HET COLLEGE VOOR DE TOELATING VAN ... · EUH071 Bijtend voor de luchtwe gen. 15540 N Virocid F, ......

15540 N

Virocid F, 20160333 TB 1

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1 BESLUIT

Op 4 maart 2016 is van

Cid Lines N.V.

Waterpoortstraat 2

B-8900 IEPER

Belgium

een aanvraag tot toelating van de biocide op basis van niet geplaatste stof(fen) (overgangsrecht)

ontvangen voor het middel

Virocid F

op basis van de werkzame stoffen glutaaraldehyde, didecyldimethylammoniumchloride en

alkyl (C12-16) dimethylbenzylammoniumchloride.

HET COLLEGE BESLUIT tot toelating van bovenstaand middel.

Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit.

Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen:

- Bijlage I voor details van de aanvraag en toelating;

- Bijlage II voor de etikettering;

- Bijlage III voor wettelijk gebruik;

- Bijlage IV voor de onderbouwing.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als

waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is

voorgeschreven.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende

aanduidingen en vermeldingen op de verpakking te worden vermeld:

15540 N


� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder

“verpakkingsinformatie” in bijlage I.

� Het toelatingsnummer.

� De etikettering zoals opgenomen in bijlage II bij dit besluit, deze moet volgens de voorschriften

op de verpakking worden vermeld.

� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in

bijlage III, onder A.

� De gebruiksaanwijzing, hetzij letterlijk, hetzij naar zakelijke inhoud, zoals opgenomen in bijlage

III, onder B. De tekst mag worden aangevuld met technische aanwijzingen voor een goede

bestrijding mits deze niet met die tekst in strijd zijn.

� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

2 WETTELIJKE GRONDSLAG

Besluit art 89, tweede lid van EU 528/2012 jo art 130a, vierde lid Wet

gewasbeschermingsmiddelen en biociden (Wgb) jo art 4, tweede

lid Wgb (oud) jo art 121 Wgb (oud) jo art 44 Wgb (oud)

Classificatie en etikettering artikel 89, tweede lid, Verordening 528/2012, jo. artikel 130a,

vierde lid, WBB, jo. artikel 50 WGB oud

Gebruikt toetsingskader RGB (Hoofdstuk 10)

3 BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en

ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn

bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het

middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar

geacht.

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die

vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd

gebruik.

3.3 Risico voor de mens

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het

werkzaam is.

15540 N


Bezwaarmogelijkheid

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de

Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes

weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College

voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.

Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift

opengesteld.

Ede, 9 februari 2018

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

Ir. J.F. de Leeuw

Voorzitter

15540 N


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

1 Aanvraaginformatie

Aanvraagnummer: 20160333 TB

Type aanvraag: aanvraag tot toelating van de biocide op basis van niet

geplaatste stof(fen) (overgangsrecht)

Middelnaam: Virocid F

Verzenddatum aanvraag: 25 februari 2016

Formele registratiedatum: * 11 april 2016

Datum in behandeling name: 30 november 2016

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

2 Stofinformatie

Werkzame stof Gehalte

glutaaraldehyde 24,0 %

didecyldimethylammoniumchloride 5,0 %

Alkyl (C12-16) dimethylbenzylammoniumchloride 5,0 %

De werkzame stoffen Alkyl (C12-16) dimethylbenzylammoniumchloride en

didecyldimethylammoniumchloride zijn opgenomen in het reviewprogramma maar voor PT03 nog

niet geplaatst op de Unielijst van Goedgekeurde Werkzame stoffen volgens Verordening 528/2012.

De werkzame stof glutaaraldehyde is per 1-10-2016 opgenomen op de Unielijst van Goedgekeurde

Werkzame stoffen volgens Verordening 528/2012 en wordt op Europees niveau verdedigd voor de

aangevraagde PT3.

3 Toelatingsinformatie

Toelatingsnummer: 15540 N

Expiratiedatum: 1 december 2027

Biocide, gewasbeschermingsmiddel of

toevoegingsstof:

Biocide

Gebruikers: Beide

4 Verpakkingsinformatie

Aard van het preparaat:

Met water mengbaar concentraat

15540 N



BIJLAGE II Etikettering van het middel Virocid F

Professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

Alkyl (C12-16) dimethylbenzylammoniumchloride

didecyldimethylammoniumchloride

glutaaraldehyde

Pictogram GHS02

GHS05

GHS06

GHS08

GHS09

GHS07

Signaalwoord Gevaar

Gevarenaanduidingen H226 Ontvlambare vloeistof en damp.

H301 Giftig bij inslikken.

H314 Veroorzaakt ernstige brandwonden en oogletsel.

H317 Kan een allergische huidreactie veroorzaken.

H330 Dodelijk bij inademing.

H334 Kan bij inademing allergie- of astmasymptomen of

ademhalingsmoeilijkheden veroorzaken.

H335 Kan irritatie van de luchtwegen veroorzaken.

H410 Zeer giftig voor in het water levende organismen, met

langdurige gevolgen.

Voorzorgsmaatregelen P210 Verwijderd houden van warmte, hete oppervlakken, vonken,

open vuur en andere ontstekingsbronnen. Niet roken.

P260 Stof/rook/gas/nevel/damp/spuitnevel niet inademen.

P264 Na het werken met dit product ... grondig wassen.

P273 Voorkom lozing in het milieu.

P280 Beschermende handschoenen/beschermende

kleding/oogbescherming/gelaatsbescherming dragen.

P301 + P310 NA INSLIKKEN: Onmiddellijk een

ANTIGIFCENTRUM/arts/... raadplegen.

P303 + P361 + P353 BIJ CONTACT MET DE HUID (of het haar):

verontreinigde kleding onmiddellijk uittrekken. Huid met water

afspoelen/afdouchen.

P304 + P340 NA INADEMING: de persoon in de frisse lucht brengen

en ervoor zorgen dat deze gemakkelijk kan ademen.

P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig

afspoelen met water gedurende een aantal minuten; contactlenzen

verwijderen, indien mogelijk. Blijven spoelen.

P342 + P311 Bij ademhalingssymptomen: een ANTIGIFCENTRUM of

een arts raadplegen.

Aanvullende

etiketelementen

EUH071 Bijtend voor de luchtwegen.

15540 N



BIJLAGE III WG/GA van het middel Virocid F

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

Toegestaan is uitsluitend het gebruik als middel ter bestrijding van:

- Bacteriën (exclusief mycobacteriën en bacteriesporen), gisten en virussen in

dierverblijfplaatsen en bijbehorende ruimten, inclusief transportmiddelen voor dieren.

Om verminderd functioneren van een Individuele Behandeling Afvalwater (IBA) bij toepassing van dit

middel op de boerderij te voorkomen, dienen afvalresten die het middel bevatten geloosd te worden

op de mestopslag of op de gemeentelijke riolering.

Draag adembescherming met beschermingsfactor 10 tijdens desinfectie.

De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden.

Het middel is uitsluitend bestemd voor professioneel gebruik.

B.

GEBRUIKSAANWIJZING

De te desinfecteren oppervlakken en materialen eerst grondig reinigen. Het middel toepassen door

middel van sprayen. Zorg dat de oppervlakken gedurende de gehele inwerktijd vochtig blijven.

Desinfectie van dierverblijfplaatsen en bijhorende ruimten voor dieren, met uitzondering van

transportmiddelen voor dieren:

Dosering: 0,25% (= 2,5 ml Virocid F aanvullen met water tot 1 liter)

Minimale inwerktijd: 30 minuten.

Desinfectie van transportmiddelen voor dieren:

Dosering: 0,5% (= 5 ml Virocid F aanvullen met water tot 1 liter)

Minimale inwerktijd: 5 minuten.

Toelatingsnummer 15540 N

Virocid F, 20160333 TB

2


BIJLAGE IV

RISKMANAGEMENT

Contents

1 Introduction ...................................................................................................................... 3

2 Identity ............................................................................................................................. 3

3 Physical and chemical properties ......................................................................................... 6

4 Analytical methods for detection and identification ............................................................. 13

5 Efficacy ........................................................................................................................... 17

6 Human toxicology ............................................................................................................ 21

7 Environment ................................................................................................................... 55

8 Conclusion ...................................................................................................................... 67

9 Classification and labelling ................................................................................................ 67

10 References .................................................................................................................. 68



3

1 Introduction

1.1 Applicant

Cid Lines N.V.

Waterpoortstraat 2

B-8900 IEPER

Belgium

1.2 Active substances

Alkyl (C12-16) dimethylbenzylammonium chloride (ADBAC), didecyldimethylammonium chloride

(DDAC) and glutaraldehyde.

1.3 Product

Virocid F

1.4 Function

Virocid F is a disinfectant (PT03)

1.5 Background to the application

This concerns an application for authorisation of a new biocidal product.

1.6 Intended uses

The proposed field of use of Virocid F is the control of:

• Bacteria (excluding mycobacteria and bacterial spores), yeasts and viruses in animal housings and

related places for animals, including animal transport vehicles, by spraying;

• Bacteria (excluding mycobacteria and bacterial spores) and yeasts in animal housings and related

places for animals, by fogging.

These uses are included in PT03.

1.7 Packaging details

1L, 10L, 20L, 60L, 200L, and 1000L in HDPE

2 Identity

2.1 Identity of the active substance

2.1.1 Alkyl (C12-16) dimethylbenzyl ammonium chloride

Common name ADBAC (non-ISO)

Name in Dutch Quaternaire ammoniumverbindingen, benzyl-C12-16-alkyldimethyl, chloriden

Chemical name Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl, chlorides

CAS no 68424-85-1

EC no 270-325-2 [EINECS]

The active substance Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl, chlorides is

included in the Union list of approved substances of EU Regulation 528/2012. For PT8 an AR is

available (June 2015, eCA Italy). For PT 1, 2, 3 and 4, a first draft CAR is available (March 2012).

The List of Endpoints below is taken from the AR on Quaternary ammonium compounds, benzyl-

(C12-16)-alkyldimethyl, chlorides (PT8, June 2015). Where relevant, some additional

remarks/information are given in italics.



4

Chemical name (IUPAC) Not applicable

Chemical name (CA) Quaternary ammonium compounds, benzyl-(C12-

16)-alkyldimethyl, chlorides

CAS No 68424-85-1

EC No 270-325-2

Other substance No. None

Minimum purity of the active substance as

manufactured (g/kg or g/l)

US ISC

940 g/kg (dry weight)

EQC


Identity of relevant impurities and additives

(substances of concern) in the active

substance as manufactured (g/kg)

None

Molecular formula Cn+9H2n+14N.Cl (n = 12, 14, 16)

Alkyl chain lengths distribution:

Chain

Length Range

C12 39 - 76%

C14 20 - 52%

C16 < 12%

Molecular mass 340.0 – 396.1 g/mol

Structural formula

N+

RCl

-

R = C12H25

C14H29

C16H33

2.1.2 Didecyldimethylammonium chloride

Common name DDAC (non-ISO)

Name in Dutch didecyldimethylammoniumchloride

Chemical name N,N-Didecyl-N,N-dimethylammonium chloride

CAS no 7173-51-5

EC no 230-525-2 (EINECS)

The active substance didecyldimethyl ammonium chloride is included in the Union list of approved

substances of EU Regulation 528/2012. For PT8 an AR is available (February 2015, eCA Italy). A first

draft CAR is available for PT1 to 4 (January 2012, eCA Italy).

The List of Endpoints below is taken from the AR on didecyldimethylammoniumchloride (PT8,

February 2015). Where relevant, some additional remarks/information are given in italics.

Chemical name (IUPAC) N,N-didecyl-N,N-dimethylammonium Chloride

Chemical name (CA) 1-decanaminium, N-decyl-N,N-dimethyl-, chloride

CAS No 7173-51-5

EC No 230-525-2

Other substance No. 612-131-00-6 (Annex I Index number)

CIPAC: 859



5



US ISC


EQC





None

Molecular formula C22H48NCl

Molecular mass 362.1 g/mol

Structural formula

N+

R Cl-

R

R = C10H21

2.1.3 Glutaraldehyde

Common name Glutaraldehyde (non-ISO)

Name in Dutch Glutaaraldehyde

Chemical name 1,5-pentanedial

CAS no 111-30-8

EC no 203-856-5 (EINECS)

The active substance glutaraldehyde is included in the Union list of approved substances of EU

Regulation 528/2012 for PT2-4, 6,11 and 12 (October 2016, eCA FI).

The List of Endpoints below is taken from the AR on glutaraldehyde (October 2016). Where relevant,

some additional remarks/information are given in italics.

Chemical name (IUPAC) 1,5-pentanedial

Chemical name (CA) Glutaraldehyde

CAS No 111-30-8

EC No 203-856-5

Other substance No.



Glutaraldehyde content in the aqueous solution is

in a range of 48.5-52.5 % (wt), 485-525 g/kg. The

theoretical dry weight specification: minimum

purity is 95.0 % (wt), 950 g/kg. The applicant

specific information and specifications are in the

confidential documents [Doc III A4.1/02

confidential (Dow) and Doc V Confidential (BASF) in

detail].




The specifications are in the confidential

documents [Doc III A4.1/02 confidential (Dow) and

Doc V Confidential (BASF)].

Molecular formula C5H8O2

Molecular mass 100.11 g/mol

Structural formula

O O

H H



6

2.2 Identity of the biocidal product

Name Virocid F

Formulation type SL

Content active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC): 5.0%

w/w

Didecyldimethylammoniumchloride (DDAC): 5.0% w/w

Glutaraldehyde: 24% w/w

Packaging information:

Material Size / content Other information

Professional use HDPE 1L, 10L, 20L, 60L,

200L, 1000L

2.3 Overall conclusions identity

The identity of the active substances and the biocidal product is sufficiently described.

Data requirements

None.

3 Physical and chemical properties

3.1 Physical and chemical properties of the active substance


The List of Endpoints below is taken from the AR on Quaternary ammonium compounds, benzyl-

(C12-16)-alkyldimethyl, chlorides (PT8, June 2015). Where relevant, some additional


Melting point (state purity) US ISC

The a.s. did not melt, but was observed to

decompose starting at approximately 150°C

(96.6%)

EQC

Melting range at atmospheric pressure of

28.9–30.2 °C (99.2%)

Boiling point (state purity) US ISC

The a.s. decomposed before melting (96.6%)

EQC

No boiling point at atmospheric pressure

(1013 hPa). The test item decomposed at a

temperature >160 °C (99.2%)

Temperature of decomposition US ISC

> 150°C

EQC

> 160°C

Appearance (state purity) US ISC

Light beige solid (96.6%)

EQC

Crystalline, tenacious and sticky solid.

Hygroscopic behaviour. White colour. Faint



7

marzipan-like odour ( 94.4%)

Relative density (state purity) US ISC

D420 = 0.96 (96.6%)

EQC

D420 = 0.929 (94.4%)

Surface tension US ISC

31.3 mN/m at 20°C (test solution: 1 g/l

aqueous solution)

EQC

28.27 mN/m at 20 ± 0.5 °C (test solution:

1.0 g/l aqueous solution)

CMC: 0.5 g/L at 20 ± 0.5 °C

Vapour pressure (in Pa, state temperature) US ISC

6.03E-04 Pa @ 20°C (extrapolated)



EQC

< 1.5E-03 Pa @ 20°C (extrapolated)

< 5.8E-03 Pa@ 25°C (extrapolated)

Henry’s law constant (Pa m3 mol -1) US ISC

5.03E-07 Pa m3 mol -1 at 20°C

EQC

< 1.15E-06 Pa m3 mol -1 at 20°C

Solubility in water (g/l or mg/l, state

temperature)

US ISC

pH 5.5: 409 g/l at 20°C

pH 6.5: 431 g/l at 20°C

pH 8.2: 379 g/l at 20°C

EQC

455 g/l in doubled distilled water at 20.0 ±

0.5 °C

444 g/l in acidic or basic solution at 20.0 ±

0.5 °C

Solubility was found to be independent of

temperature

Solubility in organic solvents (in g/l or mg/l,

state temperature) (Annex IIIA, point III.1)

US ISC

ethanol: > 250 g/l at 20°C

isopropanol: > 250 g/l at 20°C

n-octanol: > 250 g/l at 20°C

EQC

isopropanol: 549 g/l at 10°C; 568 g/l at

20°C; 586 g/l at 30°C

n-octanol: 459 g/l at 20°C

Stability in organic solvents used in biocidal

products including relevant breakdown

products (IIIA, point III.2)

US ISC

Ethanol: Stable – < 5% loss over 2 weeks at

55 °C

Isopropanol: Stable – < 5% loss over 2

weeks at 55°C

(confirmed by supporting information)

EQC

Not required: no organic solvent is used in

the representative biocidal product

Partition coefficient (log POW) (state US ISC



8

temperature) Not determined (EC methods A.8 not

applicable for surfactants). Assessment by

KOWWIN is inaccurate (software database

very limited for surfactants). log POW could be

roughly obtained from solubility in n-octanol

and water. However, this calculation is of no

use with regard to environmental fate and

behaviour and secondary poisoning risk

assessment (experimental BCF available)

EQC

0.004 @ 20°C (calculated from individual

solubilities in n-octanol and water)

Dissociation constant (not stated in Annex IIA

or IIIA; additional data requirement from

TNsG)

Not applicable. The a.s. is fully dissociated in

water

UV/VIS absorption (max.) (if absorption > 290

nm state ε at wavelength)

US ISC

The UV/VIS absorption spectra were

consistent with the assigned structure of the

active substance.

EQC

No absorption above 290 nm in the neutral,

acidic and basic media

Photostability (DT50) (aqueous, sunlight, US ISC

The photolysis data available for DDAC are

adequate for this active substance. The test

substance is photolytically stable in absence

of a photosensitising agent.

EQC

No absorption above 290 nm in UV spectrum

Quantum yield of direct phototransformation

in water at > 290 nm

Not applicable: no adsorption above 290 nm

in UV spectra

Flammability or flash point Not flammable

Explosive properties Not explosive

Oxidising properties Not oxidising

Auto-ignition or relative self ignition

temperature

No self-ignition was observed up to the

maximum test temperature (≈400°C)

3.1.2 Didecyldimethylammonium chloride



The List of Endpoints below is taken from the

AR on didecyldimethylammoniumchloride

(PT8, February 2015). Where relevant, some

additional remarks/information are given in

italics.Melting point (state purity)

US ISC

The melting range is from 188 to 205°C

(98.2%)

EQC

The melting range is from 94 to 100°C

(88.2%)



9

Boiling point (state purity) US ISC

The substance decomposes before boiling

(98.2%)

EQC

The substance decomposes under boiling

(88.2%)

Temperature of decomposition US ISC

ca. 280°C (98.2%)

EQC

> 180°C (88.2%)

Appearance (state purity) US ISC

Light-coloured solid with aromatic odour

(98.2%)

EQC

Clump building powder with hygroscopic

behaviour. White/slight yellowish colour.

Moderate mushroom-like odour (95.0%)

Relative density (state purity) US ISC

D420 =0.902 (98.2%)

EQC

D420 = 0.8651 (95.0%)

Surface tension US ISC

27.0 mN/m at 20°C (test solution: 1 g/l

aqueous solution)

EQC

25.82 mN/m at 20 ± 0.5 °C (test solution:

1.0 g/l aqueous solution)

CMC: 0.65 g/l at 20 ± 0.5 °C

Vapour pressure (in Pa, state temperature) US ISC

5.9E-06 Pa @ 20C (extrapolated)

1.1E-05 Pa @ 25C (extrapolated)

2.3E-04 Pa @ 50ºC (extrapolated)

EQC

< 1.5E-3 Pa @ 20C (extrapolated)

< 5.8E-3 Pa @ 25C (extrapolated)

Henry’s law constant (Pa m3 mol -1) US ISC

4.27E-09 Pa m3 mol-1 @ 20C

EQC

< 8.4E-7 Pa m3 mol-1 @ 20°C


temperature)

US ISC

pH 2.2: 500 g/l at 20 °C

pH 9.2: 500 g/l at 20 °C

EQC

645 g/l in doubled distilled water at 20.0 ±

0.5°C

625 g/l in acidic or basic solution at 20.0 ±

0.5°C

Solubility was found to be independent of

temperature



10


state temperature) (Annex IIIA, point III.1)

US ISC

acetone: > 600 g/l @ 20ºC

methanol: > 600 g/l @ 20ºC

n-octanol: > 250 g/l @ 20ºC

EQC

isopropanol:

942 g/l @ 10°C

906 g/l @ 20°C

953 g/l @ 30°C

n-octanol:

269 g/l @ 20°C



products (IIIA, point III.2)

ISC

ethanol: Stable < 5% loss for 14 days

at 55°C

isopropanol: Stable < 5% loss for 14 days

at 55°C

EQC

After 14 days at 54 ± 2 °C, DDAC is

concluded to be stable in isopropanol (also

confirmed by the accelerated storage

stability test on the isopropanol-based

biocidal product DDAC-50).

Partition coefficient (log Pow) (state

temperature)

US ISC

Not determined (EC methods A.8 not

applicable for surfactants). Assessment by

KOWWIN is inaccurate (software database

very limited for surfactants). log POW could be

roughly obtained from solubility in n-octanol

and water. However, this calculation is of no

use with regard to environmental fate and

behaviour and secondary poisoning risk

assessment (experimental BCFfish available)

EQC

-0.41 @ 20°C (calculated from individual

solubilities in n-octanol and water)

Dissociation constant (not stated in Annex IIA

or IIIA; additional data requirement from

TNsG)

Not applicable. DDAC is fully dissociated in

water



US ISC

ca. 0% after 30 days (direct)

ca. 7% after 30 days (indirect)

EQC

Not applicable: no absorption above 290 nm

in UV spectrum

CONCLUSION TO BE TAKEN INTO

ACCOUNT AT PRODUCT

AUTHORIZATION: stable (US ISC)


in water at > 290 nm (point VII.7.6.2.2)

Not applicable

Flammability Not flammable

Explosive properties Not explosive

Oxidising properties Not oxidising



11

Auto-ignition temperature US ISC

Relative self-ignition temperature of 195°C

EQC

No self-ignition observed up to 403°C


The List of Endpoints below is taken from the AR on glutarldehyde (October 2016). Where relevant,


Melting point (state purity) Peak maximum ca. -18 ºC (BASF)

-18 to -21.2 ºC (50 % w/v ) (Dow)

Boiling point (state purity) 101.5 °C at 987.1 hPa (ca. 50 g/100 g aqueous

solution) (BASF)

100.7 ºC at 1013 hPa (50 % w/v) (Dow)

Temperature of decomposition 1.Peak:

Onset temperature: 85 °C

Peak temperature: 246 °C

2.Peak:

Onset temperature: 330 °C

Peak temperature: 385 °C

(BASF)

For Dow, there is no information, but this is not an

absolute requirement in case the temperatures of

melting and boiling have been determined,

according to Guidance on information

requirements.

Appearance (state purity) Free flowing clear liquid (50 % solution) (BASF)

Clear colourless liquid, sharp odour (50 % w/v)

(Dow)

Relative density (state purity) 1.129 (50 % solution) (BASF, Dow)

Surface tension ca. 68 mN/m at 20 °C, (0.1 % solution) (BASF)

72.4 mN/m at 20 ºC, (0.05 % solution) (Dow)

Vapour pressure (in Pa, state temperature) 44 Pa at 20 °C (BASF, Dow), 100 % glutaraldehyde

Henry’s law constant (Pa m3 mol -1) 0.0086 Pa×m3/mol (calculated by RMS)


temperature)

pH 5, 7, 9 (20.2+/- 0.1 °C): miscible (BASF)

pH not measured: ≥ 51.3 g/100ml at 21 °C (Dow)

Glutaraldehyde is not expected to ionize in water

based on its chemical structure, therefore testing

at different pH values was not considered

necessary (Dow).


state temperature)

Methanol: fully soluble

1,4-dioxane: fully soluble

at 20 °C and at 30 °C

(BASF)

Isopropanol: fully soluble (≥ 51.3 g/100 ml)

Acetone: fully soluble (≥ 51.3 g/100 ml)

Ethyl acetate: 59 g/100 ml

Dichloromethane: 70 g/100 ml

n-hexane: 0.19 g/100 ml

Toluene: 8.5 g/100 ml



12

at 21 °C

(Dow)



products

Not applicable (organic solvents not used in

biocidal products)

Partition coefficient (log POW) (state

temperature)

pH 5 : -0.41 at 23 +/- 1 °C

pH 9 : -0.80 at 23 +/- 1 °C

pH 7 :-0.36 at 23 +/- 1 °C

(BASF)

pH not reported: -0.33 at 25 ºC

(Dow)

Hydrolytic stability (DT50) (state pH and

temperature)

See Ch. 4: Fate and Behaviour in the Environment

Dissociation constant Glutaraldehyde has no ionisable groups, and no

ionisation/dissociation in water is expected.



Medium λmax ε

[nm] [l*mol-1*cm-1]

neutral 234 14.9

neutral 282 5.9

acidic 234 14.5

acidic 282 6.1

basic 235 478.2

basic 283 22.3

max. at 234 nm. There are no peaks above 290 nm.

The ε is below 10 at wavelengths of 290 nm or

greater. (BASF, Dow)

Photostability (DT50) (aqueous, sunlight, state

pH)



in water at Σ > 290 nm


Flammability Not flammable , 50% glutaraldehyde (BASF, Dow)

Auto Ignition Temperature = 395 °C at 1002 – 1006

hPa (BASF)

Explosive properties Not explosive (BASF, Dow)

3.2 Physical and chemical properties of the biocidal product

Appearance Clear, colourless liquid with aldehyde odour

Explosive properties No explosive properties

Oxidative properties Not oxidising

Autoflammability Not autoflammable

Flashpoint The applicant has reported two inconsistent values for the

flashpoint: 65 °C and 48 °C. No study report was provided,

however.

Based on the concentration of flammable constituents in

the product, it is expected the flash point of the product is

below 60°C, but exceeds 23°C. Therefore, H226 is assigned.

pH 1% solution pH (neat): 4.22

Particle size distribution Not applicable, not a solid

Surface tension No data

Viscosity < 50 mPa.s



13

Relative density 1.030-1.070

Storage stability/Shelf life/Packaging Shelf life claim: 3 years

Tested at 54°C for two weeks in HPDE packaging.

Tested parameters: ADBAC content, DDAC content,

glutaraldehyde content, pH, and density.

All parameters remained within acceptable limits.

A long term stability study is started in February 2016.

Based on the provided data, shelf life is 2 years in HDPE is

assigned.

Technical properties Dilution stability and persistent foaming should be

determined for an SL. Experimental data on these

properties have not been provided. Since the product is not

expected to become unstable due to dilution, this is

acceptable for the dilution stability.

The product is expected to foam. It is not necessary to test

the persistent foaming because skin protection is already

prescribed.

Physical and chemical compatibility Not applicable, Virocid F does not come in contact with

other products.

3.3 Overall conclusions physical and chemical properties

The physical and chemical properties of the active substances and the biocidal product are

sufficiently described by the available information.

Shelf life is 2 years in HDPE.

Data requirements

None.

4 Analytical methods for detection and identification

The List of Endpoints below of Quaternary ammonium compounds, benzyl-(C12-16)-alkyldimethyl,

chlorides is taken from the AR (PT8, June 2015). Where relevant, some additional




The List of Endpoints below is taken from the AR on glutaraldehyde (October 2016). Where relevant,



Technical as (principle of method) US ISC

HPLC with evaporative light scattering

detection (ELSD). Confirmation by LC-MS

EQC

Analysis by RP-HPLC/DAD



14

(confirmation of identity of each a.s.

constituent by spectral match versus

relevant standards)

Impurities in technical as (principle of

method)

US ISC

HPLC-ELSD (identification by LC-MS)

Titration method

IC coupled with conductivity detector; AAS

Karl-Fischer titration and GC/FID for process

solvents

EQC

RP-HPLC/MS-MS, with two ion transitions

considered (one as quantifier, one as

qualifier)

GC-MS

ICP-OES

Karl-Fischer titration

4.1.2 Didecyldimethylammoniumchloride

Technical as (principle of method) US ISC

HPLC with evaporative light scattering

detection (ELSD). Confirmation by LC-MS

EQC

Analysis by RP-HPLC/MS-MS [parent ion

(m/z): 326; daughter ions (m/z): 186, 57]

Impurities in technical as (principle of

method)

US ISC

HPLC-ELSD (identification by LC-MS)

Titration method

IC coupled with conductivity detector; AAS

Karl-Fischer titration and GC/FID for process

solvents

EQC

RP-HPLC/MS-MS, with two ion transitions

considered (one as quantifier, one as

qualifier)

GC-MS

ICP-OES

Karl-Fischer titration and HPLC/UV for

process solvents


Technical active substance (principle of

method)

Potentiometric titration (BASF)

HPLC-UV (Dow)

Titration (Dow)

For additional information required at product

authorisation see Doc IIA and the Doc IIIAs.

Impurities in technical active substance

(principle of method)

GC-MS-FID (BASF)

Karl-Fisher titration (BASF)

GC-TCD (Dow)



15

IEC-CD (Dow)

For additional information required at product

authorisation see Doc IIA and the Doc IIIAs.

4.2 Analytical methods for analysis of the biocidal product

Preparation (principle of method) ADBAC and DDAC: HPLC-ELSD

Glutaraldehyde: HPLC-UV/Vis


Food/feed of plant origin (principle of

method and LOQ for methods for

monitoring purposes)

Not required.

Food/feed of animal origin (principle of



Not required.

Soil (principle of method and LOQ) EQC

Extraction with acetonitrile containing

1% TFA. After centrifugation and dilution

with water, analysis by RP-HPLC/MS-MS (two

mass transitions validated for each a.s.

constituent). LOQ = 0.05 mg a.s./kg

LOQ (for each individual constituent) =

0.0167 mg/kg

Water (principle of method and LOQ) EQC

Samples over SPE cartridges. After drying,

elution with acetonitrile : HPLC water (60:40,

v/v) + 1% HCOOH. Analysis by RP-HPLC/MSMS

(two mass transitions validated for each

a.s. constituent). LOQ = 0.1 μg a.s./L

LOQ (for each individual constituent) =

0.0133 μg/L

Air (principle of method and LOQ) Not required

Body fluids and tissues (principle of

method and LOQ)

Not required. The a.s. is neither toxic nor highly toxic

Based on the intended use analytical methods to determine residues of quaternary ammonium

compounds, benzyl-(C12-16)-alkyldimethyl, chlorides in food/feed of animal and plant origin are not

required.

Since the product is applied as spray, an HPLC-ELSD method to determine residues in air with an loq

of 40 µg/m3 has been provided. The method was validated and is acceptable.

4.3.2 DDAC

Food/feed of plant origin (principle of



Not relevant based on the intended use




Not relevant based on the intended use

Soil (principle of method and LOQ) US ISC



16

Extraction with propan-2-ol:water:

hydrochloric acid (90:10:0.1, v/v/v)

containing 0.01M ammonium formate prior

to dilution with water:hydrochloric acid

(100:0.1, v/v) containing 0.01 M ammonium

formate. Analysis by RP-HPLC/MS-MS

[parent ion (m/z): 326; daughter ions (m/z):

186, 43]. LOQ = 0.01 mg/kg (sandy loam

and clay)

EQC

Extraction with acetonitrile containing

1% TFA. After sonication and centrifugation,

dilution (factor 2) with water containing

1% TFA. Analysis by RP-HPLC/MS-MS

[parent ion (m/z): 326; daughter ions (m/z):

186, 57]. LOQ = 0.02 mg/kg

Water (principle of method and LOQ) US ISC

Dilution (factor 2) with propan-2-

ol:water:hydrochloric acid (90:10:0.2, v/v/v)

containing ammonium formate (0.02 M).


(m/z): 326; daughter ions (m/z): 186, 43].

LOQ = 0.1 μg/L (ground, drinking and

surface water)

EQC

Samples over SPE cartridges. After drying,

elution with 5 mL of acetonitrile. Dilution of

0.6 mL of the solution with 0.4 mL of water.


(m/z): 326.; daughter ions (m/z): 186, 57].

LOQ = 0.1 μg/L (ground and drinking water)

Enrichment over SPE cartridges. Elution with

acetonitrile and dilution (factor 2) with water

containing 02% TFA. Analysis by RPHPLC/

MS-MS [parent ion (m/z): 326;

daughter ions (m/z): 186, 57].

LOQ = 0.04 μg/L (surface water)

Air (principle of method and LOQ) Not required.

Body fluids and tissues (principle of

method and LOQ)

Not required. Didecyldimethyl ammonium chloride is not

classified as toxic or highly toxic

Based on the intended use analytical methods to determine residues of didecyldimethyl-ammonium

chloride in food/feed of animal and plant origin are not required.

Since the product is applied as spray, an HPLC-ELSD method to determine residues in air with an loq

of 40 µg/m3 has been provided. The method was validated and is acceptable.


Soil (principle of method and LOQ) Waived, Persistence or accumulation of

glutaraldehyde or its metabolites in soil is not

expected (BASF)

LC-MS/MS, 0.05 mg/kg (Dow)

The method is not required since the DT50 < 3 days



17

Air (principle of method and LOQ) [HPLC/UV, 18 µg/m3 (BASF)

HPLC/UV, 55.0 ng/sample (STS: 0.44 ppb or 1.8

µg/m3; LTS: 0.027 ppb or 0.11 µg/m3 ) (Dow) ]

It has been agreed that a new method will be

submitted before product authorisation

Water (principle of method and LOQ) GC-MS, LOQ = 0.05 µg/l (for drinking water and

surface water) (BASF)

LC-MS-MS, 0.1 µg/l (for drinking water and surface

water) (Dow)

Body fluids and tissues (principle of method

and LOQ)

Rat blood: GC-MS, 20 ng/g (Dow)

Body tissues: waived (BASF, Dow) It is technically

impossible at this time to analyse glutaraldehyde in

animal tissues as the glutaraldehyde will react with

the biological material, followed by rapid

metabolisation and elimination.

Food/feed of plant origin (principle of method

and LOQ for methods for monitoring

purposes)

Waived (BASF, Dow) The product is not intended to

be added to food and feedstuffs or be used in

facilities during food processing. Only by accident

may trace amounts of glutaraldehyde be on the

surface of food and feedstuffs. Due to evaporation,

photodegradation and rapid reactions with

proteins, only trace amounts would be expected

even in the case of accident.


method and LOQ for methods for monitoring

purposes)

Waived (BASF, Dow). It is technically impossible at

this time to analyse glutaraldehyde in animal

tissues as the glutaraldehyde will react with the

biological material, followed by rapid

metabolisation and elimination.

Based on the intended use analytical methods to determine residues of glutaraldehyde in food/feed

of animal and plant origin are not required.

Since the product is applied as spray, an HPLC-UV method to determine residues in air with an loq of

1 µg/m3 has been provided. The method was validated and is acceptable.

4.4 Overall conclusions methods of analysis

The submitted analytical methods meet the requirements.

Data requirements

None.

5 Efficacy

5.1 Function

Virocid F is a disinfectant based on 5% w/w Alkyl (C12-16) dimethylbenzylammoniumchloride, 5%

w/w didecyldimethylammoniumchloride and 24% w/w glutaraldehyde.

5.2 Field of use envisaged

The proposed field of use of Virocid F is the control of:


related places for animals, including animal transport vehicles, by spraying;



18

• Bacteria (excluding mycobacteria and bacterial spores) and yeasts in animal housings and related

places for animals, by fogging.

These uses are included in PT03.

The product is intended for professional use.

5.3 Effects on target organisms and efficacy

5.3.1 Efficacy data submitted and evaluation of data

Thirteen studies were provided and used in this assessment. These are summarised in Table 1.

Table 1. Summary of studies assessed

Test (version) Phase, step

Test organism Test parameters Results*

Bacteria (excluding mycobacteria and bacterial spores)

EN 1656 (2009) 2, 1

Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Proteus vulgaris

Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C

log R>5.23: 0.25 %; Clean; 30 min; 10°C

EN 1656 (2009) 2, 1



log R>5.03: 0.5 %; Clean; 5 min; 10°C

EN 14349 (2007) 2, 2


Concentration (%): 0.25 & 0.5% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C

log R>4.0: 0.25 %; Clean; 30 min; 10°C

EN 14349 (2012) 2, 2



log R>4.00: 0.25 %; Clean; 5 min; 10°C

NFT 72-281 (2014) Simulated-use

Orientation of the

surfaces: Vertically, at

a height of 1m (+/-

10%), and a distance

from the fogger of

2,6m (+/- 10%),

Staphylococcus aureus Enterococcus hirae Pseudomonas aeruginosa Escherichia coli

Concentration (%): 10% (2.4 ml Virocid F/m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 20°C Relative humidity (%):

log R>5.09: 10 %; Clean; 1 hour; 20°C



19



inoculum oriented at

the opposite of the

fogger.

40 – 80 Room volume: 33 m3

Fogging device: Nebulo Type Europa 700W


Orientation of the


a height of 1m (+/-


from the fogger of

2,6m (+/- 10%),


the opposite of the

fogger.


Concentration (%): 10% (2,4 ml Virocid F /m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 19 – 21.5 to 27°C (final) Relative humidity (%): 62 – 74 to 90 (final) Room volume: 33 m3

Fogging device:

Nebulo Type Europa 700W

log R>5.09: 10 %; Clean; 1 hour; 20°C

Yeasts

EN 1657 (2005) 2, 1

Candida albicans Concentration (%): 0.25, 0.5 & 1% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C

log R>4.07: 0.25 %; Clean; 30 min; 10°C

EN 1657 (2005) 2, 1


log R>4.18: 0.5 %; Clean; 5 min; 10°C

EN 16438 (2014) 2, 2


log R>3.87: 0.25 %; Clean; 30 min; 10°C


Orientation of the


a height of 1m (+/-


from the fogger of

2,6m (+/- 10%),


the opposite of the

fogger.

Candida albicans Concentration (%): 10% (2.4 ml Virocid F/m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 20°C Relative humidity (%): 40 – 80 Room volume: 33 m3

log R>5.99: 10 %; Clean; 1 hour; 20°C



20



Fogging device:


NFT 72-281 (2014) Simulated-use Orientation of the


a height of 1m (+/-


from the fogger of

2,6m (+/- 10%),


the opposite of the

fogger.

Candida albicans Concentration (%): 10% (2,4 ml Virocid F/m3) Interfering substances: 3 g/l BSA Contact time: 1 hour (15 minutes fogging – 45 minutes aeration time) Test temperature: 19 – 21.5 to 27°C (final) Relative humidity (%): 62 – 74 to 90 (final) Room volume: 33 m3

Fogging device:


log R>5.99: 10 %; Clean; 1 hour; 20°C

Viruses / Bacteriophages

EN 14675 (2006) 2, 1

Bovine enterovirus Concentration (%): 0.1, 0.25 & 0.5% Interfering substances: 3 g/l BSA Contact time: 30 min Test temperature: 10°C

log R>4.0: 0.25 %; Clean; 30 min; 10°C

EN 14675 (2006) 2, 1

Bovine enterovirus Concentration (%): 0.1, 0.25 & 0.5% Interfering substances: 3 g/l BSA Contact time: 5 min Test temperature: 10°C

log R>4.1: 0.5 %; Clean; 5 min; 10°C

The available information was sufficient to evaluate the efficacy of Virocid F for control of bacteria

(excluding mycobacteria and bacterial spores), yeasts and viruses, considering evaluation is done

under article 121 of the WGB. For spray application the studies show that Virocid F complies with the

criteria for lg reduction for PT03 disinfectants for the key species of the target organisms, when used

in accordance with the instructions described on the WG/GA. For fogging application additional

information was required. The fogging application is withdrawn at the applicant’s request.

5.3.2 Evaluation of the label (WG/GA)

The applicant has provided a WG/GA in Dutch. This has been adapted to our standards.

Regarding the dose instruction for fogging (diffusion time, contact time, monitoring of the

concentration of active ingredients) there are still some issues that need clarification.

For the claimed spray applications it was added to the WGGA that surfaces have to stay wet with

spray solution during the entire contact time.

5.4 Mode of action

ADBAC

C12-16-ADBAC is a cationic surfactant type active substance. Since it is surface active, it has fair

wetting properties and reacts strongly with cell walls of microorganisms. Its mode of action,

therefore, is to destroy the cell walls by sticking on the exterior structures and by entering and



21

disintegrating the inner phospholipid-bilayer-based membrane structures. Due to its interaction with

phospholipid-bilayer-based structures, it severely alters the cell wall permeability, disturbs

membrane-bound iontranslocation mechanisms and may facilitate the uptake of other biocides.

DDAC

DDAC has properties similar to the benzyl QUATS but with organic soil and hard water tolerance.

DDAC is a cationic surfactant type active substance. Due to its interaction with phospholipid-bilayer

structures, it severely alters the cell wall permeability, disturbs membrane-bound ion-translocation

mechanisms, and may facilitate the uptake of other biocides.

Glutaraldehyde

The activity of glutaraldehyde is reported to be due to its reaction with nucleophilic cell components,

where it forms irreversible cross-links with enzymes and other proteins, ultimately resulting in cell

death.

5.5 Limitations on efficacy including resistance

5.5.1 General limitations

The following limitations are mentioned:

- for all application methods, the surfaces have to be cleaned prior to disinfection;

- for fogging application a minimum temperature of 20oC is required.

- for fogging application the volume of the animal housing should not exceed 150 m3.

5.5.2 Resistance

Virocid F is a combination of three active ingredients (glutaraldehyde and two quaternary

ammonium compounds) with different disinfecting mechanisms which extends the efficacy of the

product and thereby reduces the risk of development of resistance. Therefore no resistant

management strategies are required.

5.6 Overall conclusions of efficacy

Based on the data submitted and considering that the evaluation is done under article 121 of the

WGB, it can be concluded that Virocid F, when used in accordance with the proposed label (WG/GA),

is effective in controlling:


related places for animals, including animal transport vehicles, by spraying.

The fogging application is withdrawn from the claim at the applicant’s request.

6 Human toxicology

ADBAC (benzyl-C8-18-alkyldimethyl ammonium chloride)

The List of Endpoints below is taken from the combined LOEPs on ADBAC-BKC (BPC-11 June 2015)

Where relevant, some additional remarks/information are given in italics.

List of endpoints

Absorption, distribution, metabolism and excretion in mammals

Rate and extent of oral absorption: US ISC

Based on data on urine excretion (5-8%) and tissue

residues (<1%), and on the highly ionic nature of

the a.s., it is expected that the oral absorption is

around 10% at non-corrosive concentrations.

EQC



22

Due to its ionic nature, C12-16-BKC is expected not

to easily pass biological membranes. Indeed, the

fraction of the oral dose absorbed was about 10%,

based on the urinary mean value 3-4% (with a

single peak value = 8.3%) and biliary excretion

values (3.7-4.6%), as well as on the absence of

residues in the carcass.

The oral absorption value of 10 % at non-corrosive

concentrations.

CONCLUSION TO BE TAKEN INTO ACCOUNT AT

PRODUCT AUTHORIZATION:

The oral absorption can be considered

approximately 10%, based on the administered

dose eliminated via urine, bile and tissue residues,

in two independent studies from the two

applicants.

The oral absorption value of 10 % at non-corrosive

concentrations.

(US ISC; EQC)

Rate and extent of dermal absorption*: US ISC

Based on data from an in vitro study on human

skin, the % absorbable was almost identical for 2

different dilutions (0.03% and 0.3%). Summing up

the radioactivity present in the receptor fluid, in

the skin at the application site (after stratum

corneum removal) and in the tape strips 6-20 the

value for dermal absorption of the a.s. is 8.3% at

non-corrosive concentrations.

EQC

Based on the level of radioactivity at the skin

application site after removal of the stratum

corneum layers (6.5-8.7% of the dose), and

considering the ionic nature of C12-16-BKC, it can

be expected that the dermal absorption is not

different from the oral one (10%).

The dermal absorption value has to be considered

of 10 % at non-corrosive concentrations.



Summing up the radioactivity present in the

receptor fluid, in the skin at the application site

(after stratum corneum removal) and in the tape

strips 6-20 the value for dermal absorption of the

a.s. is 8.3% at both tested concentrations (i.e., at

non-corrosive concentrations)

(US ISC; EQC)

Distribution: US ISC

Most radioactivity was confined to the intestines.

Levels in central organs (liver and kidney) were low

and decreased rapidly over time

EQC

The plasma, blood and organ radioactivity levels



23

were essentially non-quantifiable. At the high oral

dose-level only, quantifiable levels of radioactivity

were found in some central organs (highest levels

in the liver and kidney) at 8 hours post-dosing;

otherwise, most radioactivity was confined to the

intestines. Levels decreased rapidly over time



Most radioactivity was confined to the intestines.

Levels in central organs (liver and kidney) were low

and decreased rapidly over time (US ISC; EQC)

Potential for accumulation: US ISC

None noted

EQC

None. No residues were measured in the carcass

after 168h.



None relevant (US ISC; EQC)

Rate and extent of excretion: US ISC

Following oral administration in rats: 87 –99%

excreted in faeces as unabsorbed material, 5 – 8%

excreted in urine

EQC

Following oral administration in rats: 87 –99%

excreted in faeces as unabsorbed material, 5 – 8%

excreted in urine



Excretion was rapid (within a 48 to 72-hour

period). The vast majority of the oral dose was

excreted in the faeces (80-90%) as unabsorbed

material; 5 – 8% excreted in urine. About 4% of the

oral dose was eliminated in the bile in a 24-hour

period

(US ISC; EQC)

Toxicologically significant metabolite US ISC

None. Four major metabolites of C12-16-ADBAC

were identified, as the product of alkyl chain

hydroxylation. It can be hypothesized that C12-16-

ADBAC metabolism is carried out by gut microflora.

EQC

None.



None

(US ISC; EQC)

* the dermal absorption value is applicable for the active substance and might not be usable in

product authorization

Acute toxicity



24

Rat LD50 oral US ISC

344 mg/kg bw

EQC

358 mg (obtained with C8-18-BKC/kg bw)

Although the test item is different, this result can

be considered valid for C12-16-BKC, based on the

similar mechanism for oral toxicity shown by

QUATS with this alkyl chain length.



350 mg/kg bw

(US ISC; EQC)

Rabbit LD50 dermal US ISC

2848 mg/kg bw

EQC

Testing not allowed, active substance is corrosive

to skin

Literature LD50 values = 800-1400 mg/kg



<2000 mg/kg bw (Literature data provided by

EQC)

Rat LC50 inhalation US ISC

Study not conducted

EQC

Study not conducted - not relevant

C12-16-BKC is not volatile (calculated vp < 1x10-2 Pa

at 20°C) and is corrosive



Study not conducted - not relevant

The a.s. is not volatile and is corrosive

(US ISC; EQC)

Skin corrosion/irritation US ISC

Corrosive

NOAEC = 0.3% in water at 2.0 mL/kg body weight

per day (2 week-treatment)

EQC

Corrosive

The maximum concentration reported in the

literature that does not produce irritating effect on

intact skin is established at 0.1% a.s.



Corrosive



25

NOAEC = 0.3% in water at 2.0 mL/kg body weight

per day (2 week-treatment/rat)


literature that does not produce irritating effect on

intact skin is established at 0.1% a.s. (US ISC; EQC)

Eye irritation US ISC

Corrosive

EQC

Testing not allowed, active substance is corrosive

to skin


literature without irritating effect in the eyes =

0.02% a.s



Corrosive.


literature without irritating effect in the eyes =

0.02% a.s

(US ISC; EQC)

Respiratory tract irritation US ISC

No study available, but expected to be corrosive

EQC





(US ISC; EQC)

Skin sensitisation (test method used and

result)

US ISC

None (Buehler Test on guinea pig)

EQC

None (modified Draize test, guinea pig)

Result confirmed by a published study with GPMT

test



None.

(US ISC; EQC)

Respiratory sensitisation (test method used

and result)

US ISC

No study available, but expected to be not a

sensitiser

EQC


sensitiser




26



sensitiser

Repeated dose toxicity

Short term

Species/ target / critical effect US ISC

No short-term study available

EQC

Rat/dog, no specific toxic effects/ critical effects:

body weight and body weight gain reduction

associated to lower food intake



Dog: no specific toxic effects/ critical effects: body

weight and body weight gain reduction associated

to lower food intake

(EQC)

Lowest relevant oral NOAEL US ISC


EQC

LOAEL: 43-53 mg/kg/day (28-day dog- Supporting

study)



LOAEL: 43-53 mg/kg/day (28-day dog- Supporting

study) (EQC)

Lowest relevant dermal NOAEL US ISC


EQC

Study not conducted – not relevant

Effects are characterised by local corrosive effects

related to concentration rather than systemic

toxicity due to dermal uptake







(US ISC; EQC)

Lowest relevant inhalation NOAEL US ISC

No study available. Expected to be

irritant/corrosive.

EQC



27


irritant/corrosive.




irritant/corrosive.(US ISC; EQC)

Subchronic


Local effects (irritation/corrosivity) at the site of

contact in all species tested. Non specific systemic

effects (e.g. reduced body weight and body weight

gain), secondary to local effects.

EQC

Rat/dog, no specific toxic effects/ critical effects:

body weight and body weight gain reduction

associated to lower food intake



Rat/dog: Local effects (irritation/corrosivity) at the

site of contact in all species tested. Non specific

systemic effects (e.g. reduced body weight and

body weight gain), secondary to local effects.

(US ISC; EQC)


13.1 mg/kg/day (1 year, Dog)

EQC

1250 ppm = 45 mg a.s./kg bw/day (90-day, Dog)



13.1 mg/kg/day (1 year, Dog)

(US ISC)


20 mg/kg bw/day (highest dose tested)

EQC







20 mg/kg bw/day (highest dose tested)

(US ISC)





28

irritant/corrosive.

EQC


irritant/corrosive.




irritant/corrosive. (US ISC; EQC)

Long term


Rat/mouse: Local effects (irritation/corrosivity) at

the site of contact in all species tested. Non

specific systemic effects (e.g. reduced body weight

and body weight gain), secondary to local effects.

EQC











(US ISC; EQC)


44 mg/kg/day (2-years rats)

EQC

47 mg/kg/day (2-years rats)



44-47 mg/kg/day (2-years rats)

(US ISC; EQC)


Study not conducted

EQC










29

(US ISC; EQC)


Study not conducted

EQC


Active substance is not volatile and corrosive




(US ISC; EQC)

Genotoxicity

In-vitro:

In-vivo:

US ISC

In vitro:

Ames test – negative (with and without metabolic

activity)

Chromosomal aberration test – negative (with and

without metabolic activity)

Mammalian cell gene mutation assay – negative

(with and without metabolic activity)

In vivo:

Micronucleus assay - negative

EQC

In vitro:

Not genotoxic in vitro gene mutation study in

bacteria and in vitro cytogeneticity and gene

mutation assays in mammalian cells



The substance can be considered not genotoxic

based on:

in vitro (Ames test, Chromosomal aberration test,

Mammalian cell gene mutation assay) and in vivo

test (Chromosomal aberration test in rat bone

marrow) (US ISC)

Carcinogenicity

Species/type of tumour US ISC

Rat/none, Mouse/none

EQC

C12-16-ADBAC is not carcinogenic



No neoplastic lesions were found that were



30

considered treatment related.

Rat study (US ISC; EQC)

Mouse study (US ISC)

Relevant NOAEL/LOAEL US ISC

The NOELs related to non neoplastic effects in

chronic oral toxicity studies were 44 mg/kg/day for

rats and 73 mg/kg/day for mice.

EQC

In rats the NOAEL for non neoplastic effects was 47

mg a.s./kg/day.



No carcinogenic effects were observed.



Reproductive toxicity

Developmental toxicity

Species/ Developmental target / critical effect US ISC

Rabbit/maternal toxicity

EQC

Rat /maternal toxicity

Rabbit / maternal toxicity



No specific concern for developmental toxicity (US

ISC; EQC)

Relevant maternal NOAEL US ISC

Rabbit: 4 mg/kg bw

EQC

Rat: 10 mg/kg bw/day

Rabbit: 3 mg/kg bw/day


PRODUCT AUTHORIZATION

No specific concern for developmental toxicity.

Maternal NOAELs consistently lower than

developmental NOAELs. Maternal effects mostly

due to gastrointestinal distress, not relevant to

systemic toxicity (US ISC; EQC)

Relevant developmental NOAEL US ISC

Rabbit: 12 mg/kg bw

EQC

Rat: > 100 mg/kg bw/day

Rabbit: > 9 mg/kg bw/day



31



No specific concern for developmental toxicity (US

ISC; EQC)

Fertility

Species/ critical effect US ISC

Rat/ cortical adrenal hypertrophy in F0 females,

lower weight gain and higher spleen weights in F1

EQC

Rat/reduced weight gain and food consumption in

parental and F1 animals



No specific concern for reproductive toxicity (US

ISC; EQC)

Relevant parental NOAEL US ISC

608 mg/kg food (≥ 30 mg/kg bw/day)

EQC

1000 mg/kg food (> 50 mg/kg bw/day)



No specific concern for reproductive toxicity.

Parental NOAELs related to general toxicity

(US ISC; EQC)

Relevant offspring NOAEL US ISC


EQC




No specific concern for reproductive toxicity.

NOAELs in F1 related to general toxicity and equal

to the parental ones (US ISC; EQC)

Relevant fertility NOAEL US ISC


EQC

> 2000 mg/kg food (> 100 mg/kg bw/day)



No specific concern for reproductive toxicity (US

ISC; EQC)

Neurotoxicity



32

Species/ target/critical effect US ISC

Study not conducted/ not relevant

EQC




No specific concern for neurotoxicity (US ISC; EQC)

Developmental Neurotoxicity


No indication from available studies

EQC




No specific concern for developmental

neurotoxicity (US ISC; EQC)

Immunotoxicity


Study not conducted. No indication of such an

effect in the available toxicity studies

EQC

Study not conducted. No indication of such an

effect in the available toxicity studies.



No specific concern for immunotoxicity. (US ISC;

EQC)

Developmental immunotoxicity



EQC




No specific concern for developmental

immunotoxicity (US ISC; EQC)

Other toxicological studies

US ISC

No further study conducted/ not relevant



33

EQC


CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION


(US ISC; EQC)

Medical data

US ISC

No substance-specific effects have been noted. No specific observations or sensitivity/allergenicity

have been reported.

EQC

Skin reactions observed after dermal exposure to C12-16-BKC can be regarded as an irritant reaction

rather than a true sensitisation reaction. This is supported by the results from animal tests, which do

not indicate a sensitising potential

CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION

Skin reactions observed after dermal exposure to C12-16-BKC can be regarded as an irritant reaction

rather than a true sensitisation reaction. This is supported by the results from animal tests, which do

not indicate a sensitising potential (EQC)

Summary for Local effects

Value Study

Dermal NOAEC 0.3% 2-week skin irritation study with

rats (US ISC)

Oral NOAEC Not data available

Summary for systemic effects

Value Study Safety

factor

AELlong-term Not relevant

AELmedium-term Not relevant

AELshort-term Not relevant

ADI* Not applicable

ARfD Not applicable

* If residues in food or feed.

MRLs

Relevant commodities Not applicable

Reference value for groundwater

According to BPR Annex VI, point 68 US ISC



34

0.1 µg/L

EQC

0.1 µg/L

Dermal absorption

Study (in vitro/vivo), species tested US ISC

In vitro study (human skin samples)

EQC

2 in vivo study available on rats, none of them

allowing a quantitative determination (oral

exposure not prevented; radioactivity in the

stratum corneum included)

Formulation (formulation type and including

concentration(s) tested, vehicle)

US ISC

C12-16-ADBAC aqueous solution (0.03% and 0.3%

w/w)

EQC

1: 1.5 and 15 mg a.s. /kg bw, as 6-hour exposure

over 10% of the body surface

2: 0.4 mL of a 0.77% w/w aqueous solution of C8-18-

BKC

Dermal absorption values used in risk

assessment

US ISC

The sum of the absorbed dose, the exposed skin

(2.18%-2.13) and the % of radioactivity present in

tape strips 6-20 gave rise to a value of 8.3%.

EQC

Estimated similar to the oral absorption (10%).



The sum of the absorbed dose, the exposed skin

(2.18%-2.13) and the % of radioactivity present in

tape strips 6-20 gave rise to a value of 8.3%.

(US ISC)

Data requirements

No additional data requirements are identified.

Local respiratory effects and determination of local Acceptable Exposure Level (AEClocal inhalation)

AEClocal inhalation

Recent data on acute inhalation exposure to ADBAC indicate an LC50 value of 53 mg/m3 in rats (4h

nose only exposure)1. In addition, a NOAEC of 0.049 mg/m3 was derived in an experiment where

mice were exposed head only during 45 minutes. Effects included a concentration dependent

decrease in tidal volume (>15%) and decreased respiratory rate at 0.23 mg/m3 as well as an increase

of inflammatory cells (neutrophils and alveolar macrophages in bronchial lavage fluid) at 19 mg/m3)2.

In the EPA RED document of ADBAC, an LC50 of > 54 mg/m3 and < 510 mg/m3 was reported.

Furthermore, the EPA RED concluded that an inhalation AEC might be derived based on the NOAEL of



35

2.4 mg/kg bw/day based on hyperactivity and laboured breathing at 7.3 mg/kg bw/day in an oral

developmental toxicity study in rabbits (also included in the endpoint list of ADBAC). However, local

effects are not considered in this study, and therefore, this route-to-route extrapolation seems not

appropriate.

Based on the available LC50 values and applying a safety factor of 100 based on the limited

information available (only LC50) with in addition a factor of 3 to account for extrapolation from lethal

to non-lethal affects, the calculated AEC would be 0.18 mg/m3. Taking the NOAEC of 0.049 mg/m3

without an additional safety factor, the AEC for local effects after inhalation is set at 0.049 mg/m3.

In view of the above considerations the AEClocal inhalation is set at 0.049 mg/m3 in a worst case approach.

DDAC (Didecyldimethylammonium chloride)

The List of Endpoints below is taken from the combined LOEPs on DDAC (BPC-11 June 2015). Where

relevant, some additional remarks/information are given in italics.

List of Endpoints


Rate and extent of oral absorption: US ISC

Based on data on urine excretion (≈3%) and tissue

residues (<1%), and on the 90% recovery of

radioactivity in faeces as unabsorbed material

DDAC oral absorption is limited to 10% at non-

corrosive concentrations.

EQC

Based on the urinary excretion (3-4%), biliary

excretion values (2.6%), the absence of residues in

the carcass, and 85-90% recovery of radioactivity in

faeces as unabsorbed material the actual absorbed

fraction is approximately10% of the orally

administered dose, at non-corrosive

concentrations.



A value of 10% oral absorption is taken forward to

risk characterization at non-corrosive

concentrations. (US ISC; EQC)

Rate and extent of dermal absorption*: US ISC

About 0.1% of a DDAC dose delivered as aqueous

solution fully penetrated human skin in vitro in 24

h; including the radioactivity present in the dermis

and epidermis at the dose site mean total

absorbable DDAC was 9.41% (rounded to 10%) at

non-corrosive concentrations.

EQC

No possible to quantify DDAC in the available

study; indication of similarity between oral and the



36

dermal bioavailability. It is estimated as a worst

case that DDAC dermal absorption is limited to

≈10%.



A value of 10% dermal absorption is taken forward

to risk characterization at non-corrosive

concentrations. (US ISC)

Distribution: US ISC

Mainly in the g.i. tract, tissue residues (<1%).

EQC

Radioactivity mainly detected in the g.i. tract, and

at a much lower level in the liver and in the kidney.



Mainly detected in the g.i. tract, and at a much

lower level in the liver and in the kidney. No

detectable residues at 168 h (US ISC; EQC)

Potential for accumulation: US ISC

None. Tissue residues (<1%)

EQC

None. No residues in the carcass



None (US ISC; EQC)

Rate and extent of excretion: US ISC

The majority (>90%) of orally administered DDAC is

excreted, very likely unabsorbed, via the faeces.

Urine excretion ≈3% in 24-48 hours

EQC

The vast majority (86-96%) of the oral dose was

excreted in the faeces as unabsorbed material.

Urinary excretion was 3-4% and biliary excretion

2.6%, in a 24-hour period.



Around 90% of the oral dose was excreted in the

faeces as unabsorbed material. Urinary excretion

was 3-4% and biliary excretion 2.6% within 24

hours (US ISC; EQC)

Toxicologically significant metabolite US ISC

None. The majority of DDAC metabolism is

expected to be carried out by intestinal flora giving

rise to hydroxylation products in the alkyl chain,

none of them exceeding 10%

EQC



37

None. Conjugated metabolites were detected in

the urine



None. The majority of DDAC metabolism is

expected to be carried out by intestinal flora

forming hydroxylation products in the alkyl chain,

none of them exceeding 10%. In addition

conjugated metabolites were excreted in urines

(US ISC; EQC)

* the dermal absorption value is applicable for the active substance and might not be usable in

product authorization

Acute toxicity

Rat LD50 oral US ISC

238 mg/kg

EQC

264 mg/kg bw



The lowest value is 238 mg/kg (US ISC)

Rabbit LD50 dermal US ISC

3342 mg/kg

EQC

No test available. Literature data : >2000 mg/kg



>2000 mg/kg (US ISC; EQC)

Rat LC50 inhalation US ISC

No test available. Not allowed since DDAC is

corrosive

EQC

No test available. Not necessary since the active

substance is not volatile, (vapour pressure < 1 x 10-

2 Pa at 20°C) and only spraying with big, not

inhaled, droplets with MMAD > 40 µm is

recommended.



Test unnecessary: DDAC is not volatile, (vapour

pressure < 1 x 10-2 Pa at 20°C and 2.3x10-4 Pa at

50ºC); only spraying with big, not inhaled, droplets

with MMAD > 40 µm is recommended; testing is

not allowed with corrosive chemicals (US ISC; EQC)

Skin corrosion/irritation US ISC

Corrosive



38

EQC

Corrosive



Corrosive (US ISC; EQC)

Eye irritation US ISC

Corrosive

EQC

Corrosive



Corrosive (US ISC; EQC)

Respiratory tract irritation US ISC

No data available. Expected to be irritant/corrosive

EQC





Skin sensitisation (test method used and

result)

US ISC

Not a skin sensitiser (Magnusson and Kligman

procedure - OECD Guideline 406)

EQC


procedure - OECD Guideline 406)




procedure - OECD Guideline 406) (US ISC; EQC)

Respiratory sensitisation (test method used

and result)

US ISC

No data available. Expected to be not a respiratory

sensitizer.

EQC


sensitizer.




sensitizer


Short term


No study available



39

EQC

Rat/gi tract/ irritation corrosivity leading to body

weight reduction.



Rat/gi tract/ irritation corrosivity leading to body

weight reduction. (EQC)


None

EQC

None. The only availbale study is by gavage in rat

/28-day/ NOAEL = 2.5 mg/kg/day: not relevant



Data available only via gavage, which is not an

appropriate route of exposure for NOAEL

derivation.


Local effects NOAEC=0.6% DDAC in water at 2

mL/kg bw per day (5 day application)

Local effects NOAEC =0.3% DDAC in water at 2

mL/kg bw per day (2-week application).

EQC

No study available.




mL/kg bw per day (5 day application) (US ISC)


mL/kg bw per day (2-week application).

(US ISC)


No study available. Not necessary.

EQC





Subchronic


Rat and dog/gi tract/ irritation corrosivity leading

to body weight reduction.

EQC




40

to body weight reduction.




to body weight reduction (US ISC; EQC)


1 year dog:

NOAEL for local effects: 3 mg/kg/d

NOAEL for systemic effects: 10 mg/kg/d

EQC

90 days dog:

NOAEL for systemic effects: 15 mg/kg/d



NOAEL for local effects: 3 mg/kg/d (US ISC)

NOAEL for systemic effects: 10 mg/kg/d (US ISC)


90-day rat

Systemic NOAEL = 12 mg/kg /d (highest dose

tested)

Local effects NOAEL = 2 mg/kg/d.

EQC

None



Systemic NOAEL = 12 mg/kg /d (highest dose

tested) (US ISC)

Local effects NOAEL = 2 mg/kg/d. (US ISC)



irritant/corrosive.

EQC


irritant/corrosive.




irritant/corrosive.

Long term


Rat/mice /gi tract/ irritation corrosivity leading to

body weight reduction.

EQC



41

Rat/mice /gi tract/ irritation corrosivity leading to

body weight reduction.



Rat and mice/gi tract/ irritation corrosivity leading

to body weight reduction (US ISC; EQC)


2 year Rat:

Non neoplastic effects lowest NOAEL: 32

mg/kg/day

EQC

2 year Rat:

Non neoplastic effects lowest NOAEL: 27

mg/kg/day



Non neoplastic effects NOAEL: 27 mg/kg/day (EQC)



EQC







irritant/corrosive.

EQC


irritant/corrosive.




irritant/corrosive.

Genotoxicity

In-vitro:

In-vivo:

US ISC

In vitro:

Ames test – negative (with and without metabolic

activation)

Chromosomal aberration test – negative (with and

without metabolic activation)

Mammalian cell gene mutation assay – negative

(with and without metabolic activation).



42

In vivo:

Chromosomal aberration test in rat bone marrow –

negative.

EQC

Not genotoxic in vitro gene mutation study in

bacteria and in vitro cytogeneticity and gene

mutation assays in mammalian cells.



DDAC can be considered not genotoxic based on:

In vitro Ames test with and without metabolic

activation (US ISC)

In vitro chromosomal aberration test with and

without metabolic activation with OECD 473 (EQC)

In vitro mammalian cell gene mutation assay with

and without metabolic activation with OECD 476

(EQC)

In vivo chromosomal aberration test in rat bone

marrow (US ISC)

Carcinogenicity

Species/type of tumour US ISC

Rat/none

Mouse/none

EQC

Rat/none



DDAC was not found to be carcinogenic (US ISC;

EQC)

Relevant NOAEL/LOAEL US ISC

None

EQC

None







Species/ Developmental target / critical effect US ISC

1) Rat / NOAEL / maternal toxicity

2) Rabbit / NOAEL /maternal toxicity



43

EQC

Rabbit/ maternal toxicity (cases of discoloured

urine, splayed legs) / severe toxicity with abortion

at top dose level (32 mg/kg)



No specific concern for developmental toxicity;

prenatal effects only seen as unspecific

consequence of maternal distress (US ISC or EQC)

Relevant maternal NOAEL US ISC

1) 0.8 mg/kg bw/day

2) 1.0 mg/kg bw/day

EQC

4 mg/kg bw

Relevant developmental NOAEL US ISC

1)≥ 16.2 mg/kg bw/day

2) ≥ 3 mg/kg bw/day

EQC

12 mg/kg bw



Prenatal toxicity only seen in rabbits, clearly

secondary to maternal effects: NOAEL 12 mg/kg

bw (EQC)

Lowest NOAEL for maternal toxicity (local effects)

in rats, not considered relevant for systemic

toxicity: 0.8 mg/kg bw (US ISC)

Fertility

Species/ critical effect US ISC

Rat /NOEL/reduced body weight and food

consumption in parental and F1-F2 animals

EQC

Rat/ two-generation/ systemic toxicity

Cortical adrenal hypertrophy in F0 females; lower

weight gain and increased spleen weight in F1



Available studies do not indicate any specific

potential for reproductive toxicity. Observed

effects concern solely general toxicity

(US ISC; EQC)

Relevant parental NOAEL US ISC




44

EQC

608 mg/kg food, corresponding to

≥ 30 mg/kg bw

Relevant offspring NOAEL US ISC


EQC

608 mg/kg food, corresponding to

≥ 30 mg/kg bw

Relevant fertility NOAEL US ISC

> 750 mg/kg food (> 31 mg/kg bw/day)

EQC

> 608 mg/kg food, corresponding to

≥ 30 mg/kg bw



No specific potential for reproductive toxicity,

overall NOAEL (parental effects) at least 31

mg/kgbw/d (608mg/kg feed) (EQC)

Neurotoxicity



EQC





(No structural similarity to known neurotoxin; no

alert for neurotoxic effects; no sign of

neurotoxicity found in sub-chronic/chronic study)

Developmental Neurotoxicity


n.a.

EQC

n.a.

Immunotoxicity



EQC





45



Developmental immunotoxicity


n.a.

EQC

n.a.


US ISC

No other study available.

EQC

No other study available.

CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION:


Medical data

US ISC

No medical reports on the manufacturing personnel have been submitted.

EQC

No study available. Statements from medical doctors from different production locations indicate

that during production no problems are found which can be related to exposure to DDAC.

CONCLUSION TO BE TAKEN INTO ACCOUNT AT PRODUCT AUTHORIZATION:

No specific observations or sensitivity/allergenicity or any medical information have been reported

(US ISC; EQC)

Summary for Local effects

Value Study

Dermal NOAEC 0.3% 2-week skin irritation study with

rats (US ISC)

Oral NOAEC 0.03% 52-week oral gavage study in

dogs (US ISC)

Summary for systemic effects

Value Study Safety

factor

AELlong-term Not relevant

AELmedium-term Not relevant

AELshort-term Not relevant

ADI* Not applicable



46

ARfD Not applicable

* If residues in food or feed.

MRLs

Relevant commodities Not applicable

Reference value for groundwater

According to BPR Annex VI, point 68 US ISC

0.1 µg/L

EQC

0.1 µg/L

Dermal absorption

Study (in vitro/vivo), species tested US ISC

In vitro study on Human dermatomed skin

membranes

EQC

In vivo study on rats (some cross-contamination

due to grooming and possible concomitant oral

exposure-quantification not possible)

Formulation (formulation type and including

concentration(s) tested, vehicle)

US ISC

1. 1.85% (w/v) DDAC in water

2. NP-1 formulation 1.85% (w/v) DDAC plus

components other than water (not specified)

EQC

1.5 and 15 mg/kg (40% DDAC in water)

Dermal absorption values used in risk

assessment

US ISC

1. 10% (for water dilutions only)

2. 17.8% (for non water dilutions formulations)

EQC

10% (as for the oral route) is taken as worst case

approach.



10% for simple aqueous formulations (US ISC)

To be checked at MS levels at the moment of

authorization of single product with other co-

formulants.

Data requirements active substance




47

Glutaraldehyde

For the active substance glutaraldehyde a AR is available for PT2, 3, 4, 6, 11 and 12 (October 2014).

The List of Endpoints below is taken from this AR. Where relevant, some additional


List of endpoints


Rate and extent of oral absorption: Approx. 37 to 51 % for both sexes depending on

dose level and method of calculation (measured as

radioactivity of 14C labelled GA). (Dow, BASF)

Oral absorption of 40 % is proposed for estimating

the systemic dose.

Rate and extent of dermal absorption for the

active substance:

10 % is proposed based on weight of evidence.

Rate and extent of dermal absorption for the

representative product(s)1:

Distribution: All organs and tissues (radioactive label)

Potential for accumulation: No potential for accumulation

Rate and extent of excretion: Rapid and almost complete, independent of the

sex

Toxicologically significant metabolite(s) Metabolites are poorly known, but none expected

to be toxicologically significant

Acute toxicity

Rat LD50 oral 77 mg/kg bw (for pure GA); R25 (Dow)

Rat LD50 dermal > 1000 mg/kg bw (for pure GA; highly dependent

on concentration) (BASF)

Rat LC50 inhalation 0.28 mg/L in male rats and 0.35 mg/L in female

rats; R23 (BASF, Dow)

Skin irritation Corrosive, R34 (Dow, BASF)

Eye irritation Corrosive, R41 (Dow, BASF)

Skin sensitization (test method used and

result)

Sensitising; Guinea pig maximisation test R43

(Dow, BASF)


Species/ target / critical effect Rat / kidney / increased kidney weight coupled

with a slight increase in urea nitrogen in females

(Dow, BASF)

Mouse / kidney / increased kidney weight (Dow)

Dog / GI tract / increased incidence of vomiting

(Dow)

Lowest relevant oral NOAEL / LOAEL NOAEL 2.9 mg/kg bw/day (2.9 and 3.6 mg/kg

bw/day for males and females, respectively), rat

(Dow, BASF)

Lowest relevant dermal NOAEL / LOAEL NOAEL/LOAEL not established: skin irritation but

no systemic effects

Lowest relevant inhalation NOAEL / LOAEL LOAEC 0.26 µg GA/L, mice (local irritant effects; no

indications of systemic toxicity other than

secondary to irritation) (Dow)

1 Please consider Q5 on Derivation of dermal absorption values of section 4.1.1 of the Manual of Technical

Agreements (MOTA) version 5.



48

Genotoxicity In vitro: Positive results in Ames test (Dow, BASF),

sister chromatid exchange assay (BASF), in vitro

chromosomal aberration assay (BASF), Forward

mutation assay (Dow, BASF).

In vivo: Slightly positive in an intraperitoneal in vivo

micronucleus test and equivocal in all oral studies

presumed due to test substance not reaching the

target organ. (BASF)

Carcinogenicity

Species/type of tumour Large Granular Lymphocytic Leukaemia in female

rats (Dow)

Testis Leydig cell adenomas in male rats (BASF)

lowest dose with tumours LGLL: 5.5 mg/kg bw/day (2-year oral study; not

treatment related) (Dow)

Leydig cells: 3.5 mg/kg bw/day (2-year oral study)

(BASF)


Species/ Reproduction target / critical effect 1. Increased resorption rate, increased post-

implantation losses, reduction in mean

placental weights (Teratogenicity study in

rabbits; Dow, BASF)

2. Testes Leydig cell hyperplasia, cystic

degeneration (2-year oral study in Wistar

rats; BASF)

3. Testes consistency changes (2-year oral

study in Fischer 344 rats; Dow)

4. Diffuse degeneration of the testes (1-year

oral study in Wistar rats; BASF)

Due to the nature and incidence of the findings

there is no ground for classification for

teratogenicity. Glutaraldehyde had little effect on

any reproduction parameters even at maternally

toxic doses and there is no ground for classification

for fertility effects.

Lowest relevant reproductive NOAEL / LOAEL 1. NOAEL 15 mg/kg bw/day

2. LOAEL 3.5 mg/kg bw/day

3. NOAEL 3.6 mg/kg bw/day

4. NOAEL 3.2 mg/kg bw/day

(The numbers refer to the studies as indicated

above)

Species/Developmental target / critical effect None in rabbits or rats (Dow, BASF)


Lowest relevant developmental NOAEL /

LOAEL

Not relevant

Neurotoxicity / Delayed neurotoxicity

Species/ target/critical effect None

Lowest relevant developmental NOAEL / Not relevant



49

LOAEL.


Respiratory irritation Moderately potent peripheral sensory irritant;

Peripheral sensory irritation test, in mice (BASF)

Respiratory sensitisation Potential respiratory sensitizer; Mouse IgE test

(Dow)

Medical data

Cohort studies and case studies have identified

respiratory and skin sensitization as the main

effects on human health. Glutaraldehyde is among

the most common causes of occupational asthma

among health care workers.

Other health risks are due to the corrosive

properties of glutaraldehyde.

Summary Value Study Safety factor

Non-professional user

ADI (acceptable daily intake, external long-

term reference dose)

Not relevant - -

AELmedium-term 0.014 mg/kg

bw/day*

Rat 90-day oral

study

100

AELlong-term 0.014 mg/kg

bw/day*

Rat 90-day oral

study

100

AECinhalation 10.6 µg/m3

(2.6 ppb)

2-year

inhalation study

in the mouse

24***

AECacute inhalation 0.5 mg/m3

(120 ppb)

Human study on

odour detection

and

chemesthetic

detection

3.2

AECdermal not

established*

Drinking water limit 0.1 µg/L As set by EU

Drinking Water

Directive

(98/83/EC)

Not relevant

ARfD (acute reference dose) 0.60 mg/kg

bw/day

Rabbit

teratogenicity

study

25

Professional user

Reference value for inhalation (proposed OEL) - - -

Reference value for dermal absorption

concerning the active substance:

10% estimated

value

- -

Reference value for dermal absorption

concerning the representative product(s)4:

10% estimated

value

- -

* AELmedium-term/ long-term is based on the NOAEL of 3.5 mg/kg bw/day of a rat carcinogenicity study

(instead of the stated 90-day oral study in rats) and corrected for 40% oral absorption.



50

** From the human volunteer- and occupational studies an NOEL of 0.2% glutaraldehyde was

derived. For the risk assessment an NOEClocal dermal of 0.2% (without additional assessment factors) will

be used.

*** AECinhalation = 0.255 mg/m3 / (2.5interspecies × 3.2intraspecies × 3LOAEC-to-NOAEC) = 0.0106

mg/m3

Data requirements


6.1 Human exposure assessment active substance

6.1.1 General aspects

Virocid F is a suspension concentrate and contains Alkyl (C12-16) dimethylbenzylammoniumchloride

(ADBAC) (5%), Didecyldimethylammoniumchloride (DDAC) (5%), and glutaraldehyde (24%) as active

substances. The proposed field of use of Virocid F is surface disinfection of animal housings and

equipment, and means of animal transport (PT3).

Virocid F is applied to the surfaces by spraying or by fogging. The application dosage is 0.5% Virocid F

in water when it is applied by spraying to disinfect of means for transport of animals, corresponding

to 0.025% ADBAC, 0.025% DDAC and 0.12% glutaraldehyde in the in-use solution. The application

dosage to disinfect animal housings is 0.25% (0.0125% ADBAC, 0.0125% DDAC and 0.06%

glutaraldehyde in the in-use solution). For application by fogging, the application dosage is 10%,

corresponding to 0.5% ADBAC, 0.5% DDAC and 2.4% glutaraldehyde.

The formulation Virocid F is for professional use.

6.1.2 Identification of main paths of professional exposure towards active substance from its use

in biocidal product

The professional user can be dermally and respiratory exposed to active substances ADBAC, DDAC

and glutaraldehyde during mixing and loading, and spraying using Virocid F. During application by

fogging no exposure of the professional user is expected because fogging is performed using a fully

automated system (IGEBA Nebulo Europe 700W) , and no person or animal may be present in the

room until the concentration of glutaraldehyde drops below 0.1 ppm, as described in the WG/GA.

The very low vapour pressure and Henry’s law constant of ADBAC and DDAC ( vapour pressure 6.03 x

10-4 Pa at 20 ºC for ADBAC and 5.9x10-6 Pa at 20oC voor DDAC, Henry’s law constant 5.03 x 10-7 Pa x

m3/mol at 20 ºC for ADBAC and 4.27x10-9 Pa m3/mol at 20 ºC for DDAC), indicates poor partitioning

of these compounds from aqueous solution. Therefore inhalation exposure to ADBAC and DDAC is

considered negligible. Local exposure of upper airway to ADBAC and DDAC is possible during

spraying.

For glutaraldehyde respiratory exposures is possible due to high vapour pressure.

As Virocid F is intended for professional use only, oral exposure is considered negligible.

6.1.3 Identification of main paths of non-professional exposure towards active substance from its

use in biocidal product

The formulation Virocid F is intended for professional use only.

6.1.4 Indirect exposure as a result of use of the active substance in biocidal product

During application of Virocid F by spraying secondary respiratory bystander exposure to the active

substances may occur. However, this exposure is expected to be lower than direct exposure of a

professional user applying the formulation by spraying. The applicant has indicated that the treated



51

surfaces does need to be washed. Therefore, secondary dermal exposure of the general public

including children visiting a farm by touching treated surfaces, and secondary exposure of animal by

licking or touching treated surfaces cannot be excluded.

6.2 Human health effects assessment product

6.2.1 Toxicity of the formulated product

No studies with Virocid F have been submitted and the classification and labelling of the formulation

has been prepared based on the calculation method described in Annex I of Regulation

1272/2008/EC.

6.2.2 Data requirements formulated product


6.3 Risk characterisation for human health

6.3.1 Professional users

Exposure by mixing/loading and application by coarse spraying

To estimate systemic and local respiratory exposure to glutaraldehyde during the application Virocid

F by spraying, Spraying Model 2 (User Guidance v.1, 2002, p.30) is considered to be applicable. Using

Spraying Model 2 is in accordance with draft final CAR for glutaraldehyde for scenario “Disinfection

of a Poultry Farm by spraying” and is also included in the HEAd hoc recommendation 6. This model

also includes mixing and loading step; therefore no separate assessment of mixing and loading is

performed. The concentration glutaraldehyde in the in-use solution is 0.12%. The indicative exposure

values are 273 mg/min for hand exposure without protective gloves, 7.8 mg/min for hand exposure

inside protective gloves, 222 mg/min for body exposure and 76 mg/m3 for respiratory exposure. The

exposure duration for professional users is considered to be 3 hours/day. The results of exposure

estimates are presented in table below.

Table T.1. Internal professional operator exposure to glutaraldehyde and risk assessment during

spraying

Route Estimated internal

exposurea (mg/kg

bw/day)

Systemic

AEL (mg/kg

bw/day)

Risk-indexb

Spraying, no PPEc, systemic effects

Dermal 0.1782 0.014 12.7

Respiratory 0.0057 0.014 0.41

Total 0.1839 0.014 13.1

Spraying, with PPEc, systemic effects

Dermal 0.0108 0.014 0.77

Respiratory 0.0005 0.014 0.04

Total 0.0109 0.014 0.81

Spraying, local effects

Route Estimated external

exposure (mg/m3)

Local

AEC (mg/m3)

Risk-indexb

Respiratory 0.091 0.0106 8.58

a Internal exposure was calculated using biological availability via the dermal route of 10 %



52

b The risk indices are calculated by dividing the internal exposure by the systemic AEL, or, for local respiratory effects, by dividing

external exposure by external AEC

c Exposure with PPE (gloves, protective clothing, respiratory protection equipment (RPE) with protection factor 10) is calculated

using indicative exposure value inside protective gloves of 7.8 mg b.p./min according to Spraying Model 2 and considering 90%

body exposure reduction due to the use of protective clothing.

Based on the risk assessment, no adverse systemic and local respiratory effects after exposure to

glutaraldehyde are expected for the protected (gloves, protective clothing and RPE with protection

factor 10) professional user after surface disinfection by spraying for 3 hours.

Before the disinfection of animal housing can take place, thorough cleaning has to be performed.

Therefore, taken in to account this cleaning procedure and other tasks than cleaning/disinfections, 3

hours exposure is considered to be a realistic assumption for farmers. According to the WG/GA the

in-use concentration of Virocid F for disinfection animal housing is 0.25%. This is half of the

concentration used in the calculation above (0.5%), which is based on the maximum in-use

concentration used in the means of animal transport. Based on the in-use concentration of 0.25%,

the risk index by disinfection of animal housing is refined to be 0.40 after 3 hours. Therefore, the use

of Virocid F is not expected to cause adverse health effects, even when this is performed by

contractors specialised in animal house disinfection.

Local dermal exposure to ADBAC, DDAC and glutaraldehyde can occur during mixing and loading of

Virocid F and during spraying. During mixing and loading, the professional user is dermally exposed

to the concentrate (containing 5% w/w ADBAC, 5% w/w DDAC and 24% w/w glutaraldehyde), and

during the application the professional user is dermally exposed to the in-use dilution of Virocid F.

The maximum dilution is 0.5%, corresponding to 0.025% w/w ADBAC, 0.025% w/w DDAC and 0.12%

w/w glutaraldehyde.

For the exposure to the concentrated product, the NOAEL for all active substances are exceeded. The

use of PPE (gloves and protective clothing) is therefore prescribed for the professional user during

mixing and loading. The concentration of glutaraldehyde in the in-use dilution (0.12%) does not

exceed the NOEL of 0.2% for glutaraldehyde and the combined concentration of ADBAC and DDAC

(0.05%) is lower compared to the NOAEL of 0.3%. Therefore no adverse health effects are expected

due to dermal exposure to ADBAC, DDAC and glutaraldehyde during disinfection by spraying. By

spraying the upper airway of the professional user may be exposed to in-use solution of Virocid F.

However, because the concentrations of ADBAC, DDAC and glutaraldehyde in the in-use solution are

all below the NOAEL, no adverse effects are expected.

Exposure by fogging

The formulate Virocid F may be applied to surfaces by fogging. For this purpose Virocid F is diluted to

10% in water, and transferred to the fogging apparatus IGEBA Nebulo Europe 700W. Exposure during

mixing and loading is already evaluated above, therefore no separate assessment is needed. The

fogging is automated process and no person or animal is allowed to be present in the room while the

room is treated. Therefore no exposure of the professional user during disinfection by fogging is

expected. However, if the professional user needs to enter the area during treatment in emergency

situations (for example the apparatus used for the fumigation is not working properly), than the

professional user could be respiratory and dermally exposed to unknown concentration of the active

substances. Therefore, the following sentence needs to be included in the WG/GA: “If a treatment

area needs to be entered due to emergency situation, wear suitable protective personal equipment

and suitable respiratory protection equipment.”

After the treatment, the room is released for use only when glutaraldehyde drops below 0.1 ppm

(=100 mg/m3), according to the WGGA. However, this concentration of 100 mg glutaraldehyde/m3 is

far higher than the local inhalation AEC of 0.0106 mg/m3 for glutaraldehyde.



53

According to the applicant the average concentration of glutaraldehyde during the fogging treatment

is 148 ppm. Assuming ventilation rate of 4 /hr (RIVM report 320005003/2006) and initial

concentration of 148 ppm (=148000 mg/m3), ConsExpo 4.1 shows that after 4.5 hours the

glutaraldehyde air concentration decreases below the inhalation AEC of 0.0106 mg/m3. Based on this

information the following sentence should be added to the WG/GA: “The room may be released for

unprotected person or animals 4.5 hours after the fogging application.”

6.3.2 Non-professional users, including the general public

The formulation Virocid F is intended for professional use only.

6.3.3 Indirect exposure as a result of use

According to the proposed WG/GA the disinfected surfaces do not need to be rinsed, meaning that

the active substances may remain on the treated surfaces. The general public (e.g. children visiting

farm) and animal may be dermally and orally exposed to ADBAC, DDAC and glutaraldehyde by

touching or licking the surfaces disinfected with Virocid F.

For local effects the sum of the concentrations of ADBAC (0.025%) and DDAC (0.025%) in Virocid F is

lower than the NOAEL (0.3%). In addition, the concentration of glutaraldehyde (0.12%) is lower than

its NOEL 0.2%. Therefore no local adverse effects are expected due to the exposure due to dermal

exposure to ADBAC, DDAC and glutaraldehyde by touching disinfected surface.

For glutaraldehyde, systemic effects need to be addressed. According to the applicant, up to 1.0-2.4

mL of Virocid F is applied per m2 from spraying and fogging, corresponding to 230-576 mg

glutaraldehyde/m2 (1-2.4 mL x 0.96 g/cm3 x 24% ). As a worse case for secondary exposure a toddler

of 10 kg was assumed to enter the treated area. The palms of both hands (115.2 cm2) becomes

contaminated by touching disinfected surface, and 10% of glutaraldehyde on hands is orally ingested

by hand-to-mouth transfer. For transfer coefficient of glutaraldehyde from treated surface to hands

18% is used, which is the worst value for transfer of dried fluid from various surface (TNsG, 2007).

Using the oral absorption rate of 40% (the draft CAR), the systemic exposure level is calculated as

following:

Amount of glutaraldehyde on hands

0.01152 m2 x 576 mg glutaraldehyde/m2 x 18% (transfer coefficient)

= 1.194 mg glutaraldehyde on hands

Systemic dermal exposure

1.194 mg x 90% x 10% (dermal absorption) = 0.107 mg

Systemic oral exposure

1.194 mg x 10% x 40% (oral absorption) = 0.048 mg

Total systemic exposure

(0.107 mg+ 0.048 mg)/10 kg bw = 0.015 mg/kg bw/day

As the calculated exposure level 0.015 mg/kg bw/day is higher than the systemic AEL of 0.014 mg/kg

bw/day (RI=1.07), adverse health effects due to secondary exposure to gultaraldehyde by using

Virocid F cannot be excluded. Therefore, the risk for the general public due to the secondary

exposure to glutaraldehyde contained in Virocid F is considered unacceptable, and the following

sentence should be included in the WG/GA : “Rinse off the surface using clean drinking water after

disinfection”. With the inclusion of the rinsing step, the dermal and oral exposure of animal to the

active substances is also considered to be acceptable.

6.3.4 Combined exposure

The formulation Virocid F is a mixture of three active substances. The combined toxicological effect

of these three active substances has not been investigated with regard to repeated dose toxicity.



54

Possibly, the combined exposure to these active substances may lead to a different toxicological

profile than the profiles based on the individual substances.

For risk assessment based on local effects, the principle of addition can be applied. During mixing and

loading, the use of PPE(gloves and protective clothing) is prescribed and therefore no local dermal

effects need to be considered. During application by spraying, the total concentration of irritating

substances (i.e. 3 active substances.) in the solution is 0.17% (0.025%+0.025%+0.12%). This value is

lower than the NOAEL of 0.2% for glutaraldehyde and the NOAEL of 0.3% for ABDAC and DDAC.

Therefore it is concluded that there is no concern for combined dermal exposure to the three active

substances.

Regarding inhalation exposure, glutaraldehyde is the only substance for which such exposure is

possible. Therefore there is no concern for combined exposure for inhalation exposure.

Only for glutaraldehyde systemic effects were evaluated, therefore no addition on systemic effects

are expected.

6.3.5 Substance of Concern

This product also contains a substance of concern, for which a Community Limit value has been set.

The risk assessment for dermal and respiratory exposure to these substances was performed using

appropriate models. Based on the risk assessment, no adverse effects are expected for the

unprotected professional user from respiratory exposure to SoC Human Toxicology 1 as a result of

the application of Virocid F, when used in accordance with WG/GA.

6.4 Overall conclusions for the aspect human health

Based on this risk assessment, it was concluded that no adverse health effects are expected for the

protected professional user (gloves, protective clothing and respiratory protection equipment with

protection factor of 10) after dermal and respiratory exposure to ADBAC, DDAC and glutaraldehyde

as a result of the application of Virocid F, when used in accordance to the WG/GA. Furthermore, the

following sentences should be added to the WG/GA: The room may be released for unprotected

person or animals 4.5 hours after the fogging application.” and “If a treatment area needs to be

entered due to emergency situation, wear suitable protective personal equipment and suitable

respiratory protection equipment.”

Furthermore, when used according to the WG/GA, no adverse health effects are expected for the

general public and animal by indirect exposure to ADBAC, DDAC and glutaraldehyde as a result of the

application of Virocid F. The following sentence should be included in the WG/GA : “Rinse off the

surface using clean drinking water after disinfection”.

6.5 Additional indirect exposure risk assessment

Based on efficacy evaluation the application by fogging is not authorised. The applicant has asked if

the restriction sentence in the WGGA: “Rinse off the surface using clean drinking water after

disinfection”, which was required due to the risk identified from indirect exposure after fogging

application could be removed. Hereafter the risk assessment for secondary exposure is performed

based on the application by spraying:

According to the applicant, 400 mL of Virocid F dilution is applied per m2 by spraying. In animal

housing and mean of animal transportation, max concentrations of Virocid F are 0.5% and 0.25%

w/w, respectively. This corresponds to the application of glutaraldehyde amount of 257 mg (400 mL

x 1.07 g/cm3 x 0.25% x 24%) per m2 in animal housing, and 514 mg (400 mL x 1.07 g/cm3 x 0.5% x

24%) per m2 in means of animal transportation.



55

For animal housing, a toddler of 10 kg was assumed to enter the treated area as the worst case.

Using the same approach as that taken in the evaluation, the systemic exposure level is calculated as

following:

Amount of glutaraldehyde on hands

0.01152 m2 x 257 mg glutaraldehyde/m2 x 18% (transfer coefficient)

= 0.533 mg glutaraldehyde on hands

Systemic dermal exposure

0.533 mg x 90% x 10% (dermal absorption) = 0.048 mg

Systemic oral exposure

0.533 mg x 10% x 40% (oral absorption) = 0.021 mg

Total systemic exposure

(0.048 mg+ 0.021 mg)/10 kg bw = 0.0069 mg/kg bw/day

The calculated exposure level 0.0069 mg/kg bw/day is lower than the systemic AEL of 0.014 mg/kg

bw/day (RI=0.50). Therefore no adverse effects are expected.

For means of transportation, exposure of animals transported is taken into consideration. The AEL

values of 0.014 mg/kg bw for glutaraldehyde is the limit value derived for human exposure. Therefor

for animal exposure assessment, an animalAELmedium-term will be derived. Considering the NOAEL of 3.5

mg/kg bw/day, correction for 40% oral absorption, and using an assessment factor of 5, an

animalAELmedium-term of 0.28 mg/kg bw/day can be derived. The assessment factor of 5 is chosen to be

in line with EFSA guidance on birds and mammals (2009). According to this guidance document the

same endpoint as in the human risk assessment, without the AF applied as part of the human risk

assessment, should be used for a mammalian chronic risk assessment. Subsequently, the exposure is

compared to the NOAEL and if long-term toxicity/exposure ratio is less than 5 an unacceptable risk

occurs. In other words, using this information, reflecting this by using an AF of 5, a resulting risk index

>1 would be considered unacceptable.

Assuming the application rate of 400 mL/m2 , glutaraldehyde residue is calculated to be 514 mg per

m2 . Using the oral absorption rate of 40% (the CAR), and assuming 100% transfer from the

disinfected surface to mouth as the worst case, the area to be licked to reach systemic AEL for a lamb

of 40 kg is calculated as following:

(0.28 mg/kg bw/day x 40 kg bw) ÷ 40% ÷ 514 mg glutaraldehyde/m2 = 0.0545 m2 =545 cm2

It is unlikely scenario to occur that a lamb licks off a disinfected surface of 545 cm2 (e.g. a square with

c.a. 23 cm side). In addition, the AEL is based on animal studies with repeated exposure (90 days or 2

year rat studies), while the exposure of animals to Virocid F is considered to be a couple of times in

their life-span. Also, the worst case 100% of glutaraldehyde is assumed to remains on disinfected

surface if the surface is left to dry, while glutaraldehyde is considered to decompose quickly.

Altogether, the risk for the animals due to the secondary exposure to glutaraldehyde contained in

Virocid F is considered acceptable.

The restriction sentence in the WG/GA : “Rinse off the surface using clean drinking water after

disinfection” is not required.

7 Environment

7.1 Introduction



56

Authorisation is requested for Virocid F containing alkyl dimethyl benzyl ammonium chloride

(ADBAC), didecyldimethyl-ammonium chloride (DDAC) and glutaraldehyde as active substances. The

biocidal product concerns a veterinary hygiene disinfectant (PT03) and is for professional use only.

The intended uses are described in Table E.1.

Table E.1. Intended uses, dose, and use concentrations of the active substances.

Area of use envisaged Concentration

active substance

in product (g/kg)

Dose (g

product/L)

Use

concentration

active

substances in

diluted solution

(g/kg)

Application rate

Disinfection of animal

housing by spraying

ADBAC: 50

DDAC: 50

GA1: 240

2.5

ADBAC : 0.125

DDAC : 0.125

GA. : 0.6

not specified

Disinfection of animal

housing by fumigation 100

ADBAC : 5

DDAC : 5

GA. : 24

2.4 ml/m³

Disinfection of veterinary

transport vehicles by

fogging

5.0

ADBAC : 0.25

DDAC : 0.25

GA. : 1.2

not specified

1 Glutaraldehyde

7.2 Product related studies

The exposure assessment is based on data for the active substances. There are no fate or ecotoxicity

data available for the product. The data for the active substances applied in the current risk

assessment are presented in appendix I.

7.3 Environmental exposure assessment

7.3.1 Chemistry and/or metabolism

ADBAC and DDAC are cationic surfactants which are characterized by near irreversible binding or

interaction with organic matter. Both active substances are classified as readily biodegradable.

Metabolites are not formed > 10% in all environmental compartments. A monitoring study (Clara et

al, 2007) conducted in nine Austrian sewage treatment plants (STPs) demonstrated that quaternary

ammonium compounds are effectively removed from waste water (98.5% removal). Metabolites of

ADBAC are not formed > 10% in all environmental compartments.

Glutaraldehyde is highly hydrophilic, non-ionisable and fully soluble in water. Although

glutaraldehyde is volatile, it does not easily evaporate from water due to its high water solubility and

corresponding low Henry constant. The active substance is hydrolytically and photolytically stable

under environmental relevant conditions. Glutaraldehyde is subject to rapid photochemical

degradation in air with a half-life of 8.2 h, and classified as readily biodegradable.

Glutaraldehyde is considered to be moderately mobile in soil and sediment based on the average

organic carbon-water partitioning coefficient (Koc) of 326 L/kg. The adsorption is considered to be

irreversible as no desorption could be observed in the test.

The active substance’s physical-chemical properties applied for the exposure assessment are

summarised in appendix I.

7.3.2 Distribution in the environment



57

Various phases in the life cycle of a product may cause emissions and environmental exposure.

Significant release to the environment will therefore occur during the application of products holding

the biocide. Table E.2 summarises the receiving environmental compartments that have been

identified as potentially exposed during the use of the product for the different applications.

Emissions from active substance production and product formulation are not part of the risk

assessment. The routes of entry into the environment are explained in more detail in the next

sections.

Table E.2. Foreseeable routes of entry into the environment on the basis of the intended use.

Main scenario Environmental compartments exposed

STP1 Freshwater2 Saltwater2 Soil3 Air

Disinfection of stables ++ + - + ++

Disinfection of veterinary

transport vehicles ++ + - - ++

++ Compartment directly exposed, + Compartment indirectly exposed, - Compartment not exposed, 1 Sewage Treatment Plant, 2 Including sediment, 3 Including groundwater.

7.3.2.1 Disinfection of stables

Disinfection of animal housing including cages, floors, walls, conveyor belts, and machinery is

common practice in stables and usually takes place at the beginning or ending of a breeding period.

Release of waste water holding residues of the product to the sewer and subsequently to the sewage

treatment plant is possible, but considering that most farms are not connected to the municipal

sewer, disposal to the manure depot is more likely. Alternatively, waste water may be collected and

transported by tankers and disposed to the sewer. If present, residues may be released to individual

sewage treatment plants (In Dutch: IBA) as well when equipment is for instance rinsed above sinks.

Residues that are released to the sewer can enter the aquatic environment via an STP or an IBA,

although some IBAs infiltrate their effluent in soils. When released to the manure, residues are mixed

with the top soil layer when manure is applied as a soil fertiliser. The active substances may be

subsequently emitted to groundwater due to leaching or transported to adjacent surface water due

to runoff or drainage systems. Application of sewage sludge as a soil fertiliser is highly unlikely in The

Netherlands as its chemical composition does not fulfil the environmental standards regarding

organic pollutants and heavy metals. In order to avoid unnecessary contamination of the receiving

soils, sewage sludge is treated as hazardous waste instead. Because animal houses are ventilated

after disinfection by fumigation, release to the air compartment and subsequent deposition on

surface water and soils is likely.

7.3.2.2 Disinfection of veterinary transport vehicles

Considering that professional use of biocides for the disinfection of veterinary transport vehicles is

regulated (Ontwerpbesluit milieubeheer – agrarisch, Wet bodembescherming), direct exposure of

soils and surface water is prevented as vehicles have to be disinfected above liquid-tight floors at

farms and slaughterhouses. Applications at farms will result in emission to the manure and

eventually to soils when manure is applied as a fertilizer, or to the sewer when present. Disinfection

of transport vehicles is however not common practice and is usually limited to isolate pathogenic

micro-organisms in case of epidemics. Most transport vehicles are disinfected on the premises of

slaughterhouses after been unloaded. Here, waste water is discharged to an on-site waste water

treatment plant and subsequently to the municipal sewer. Pre-treatment of waste water is

mandatory for slaughterhouses in order to fulfil the standards set by local water authorities

regarding e.g. suspended solids, lipids contents, and biological oxygen demands (Besluit algemene

regels voor inrichtingen milieubeheer).

7.3.3 Predicted environment concentration calculations



58

7.3.3.1 General

Predicted Environmental Concentrations (PECs) were calculated according to relevant exposure

scenario documents (ESDs, release to the environment), the guidance on biocide legislation, Part B,

volume IV (distribution in the environment), and the model SimpleTreat (concentrations for micro-

organisms in a STP and the STP’s effluent) by using the default values for parameters, unless

otherwise noted. Release of active substances during the waste phase of the end-products is not

assessed, because it is assumed that end-products to which the active substances are added are

disposed as solid waste and usually incinerated. Possible pH effects on the environment were not

considered, because the STP and receiving compartments are expected to have sufficient buffering.

The applied methods are explained below. The risk assessment is based on the active substance’s

physical-chemical properties as listed in appendix I and the concentrations as listed in Table E.1.

Monitoring data demonstrated that STPs effectively remove ADBAC and other quaternary

ammonium compounds from waste water (Clara et al., 2007). Concentrations in surface water of

ADBAC and DDAC were therefore based on monitoring data (98.5% removal) instead of the

distribution over sewage sludge, air, and water by SimpleTreat.

Because sewage sludge is not applied as a soil fertiliser in The Netherlands, emission to soils is

negligible when vehicles are disinfected on the slaughterhouses’ premises. No PECs were therefore

calculated for soils and groundwater for this type of use.

7.3.3.2 Disinfection of stables

Emission to the environment was calculated according to the stable disinfection scenario taken from

the ESD for PT03 An application rate of 0.4 L sanitising solution/m² was applied as a worst-case for

surface disinfection. For disinfection by spraying or fumigation emission was based on the stable

volumes taken from the ESD for insecticides in stables (PT18). Although these volumes are higher

than the advised maximum room volume per fogging device (150 m³), application of multiple devices

and/or disinfection of various small sized stables is realistic.

As the amount of disinfections per year and the sizes of the surfaces to be disinfected strongly

depend on the type of animal housed, emission to soils due to disinfection of stables varies among

the different farm industries. The ESD distinguishes 18 types of farms, which were in this risk

assessment grouped in dairy cattle, beef cattle, pig farming, and poultry. Only the highest PECs and

PEC/PNEC ratios for each category are presented in the current risk assessment report. Because duck

farming is worst-case considering the number of annual applications (13 vs. 1-7 ), assessments were

made for poultry with and without ducks for comparison. Note that battery cages are not allowed in

Europe anymore (Regulation No 1999/74/EC of the European Parliament). This type of farming was

therefore excluded from the poultry group.

7.3.3.3 Disinfection of veterinary transport vehicles

Emission to the STP resulting from the disinfection of veterinary transport vehicles was only

calculated for mammals being the worst case. Considering that large scale disinfection of veterinary

transport vehicles is done on the premises of slaughterhouses where waste water is pre-treated by

grease and sediment separation tanks, it was assumed that 90% is eliminated during wastewater pre-

treatment. This assumption is justifiable as glutaraldehyde is readily biodegradable and quaternary

ammonium compounds are extreme lipophilic. Emission was based on an application rate of 0.4

L/m².

Indirect release to soils via manure is likely when vehicles are disinfected on farms. It is, however,

assumed that the frequency of disinfection is similar to that of stables, because stables are only

disinfected when animals are transported to or from the farm. Considering that the surface of

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:286:0001:0030:EN:PDF



59

transport vehicles is negligible towards that of stables, the risk for soil organisms is covered by the

stable scenario.

7.3.3.4 Groundwater

FOCUS PEARL (PEARL model © RIVM/Alterra, FOCUS v. 4.4.4) was used to estimate concentrations in

shallow groundwater by using the default parameters for the Kremsmünster scenario which is

assumed representative for most Dutch agricultural conditions regarding crop, soil and climate. Grass

and winter cereals were selected as crops for grassland and arable land, respectively. The worst-case

concentrations in soil were recalculated to kg/ha in order to be entered in PEARL. Manure was

distributed on grassland 1st of February, 26th of March, 18th of May and 10th of July and on arable land

3rd of October, and applied by injection for which the depth was adjusted accordingly (10 cm). For

arable land, an incorporation depth of 20 cm was used. Uptake by crops was not considered and a

simulation period of 20 years was chosen. The dose was based on the expected soil concentration

direct after manure application. The compounds’ physical-chemical properties are listed in Appendix

I.

7.4 Environmental effect assessment

Risk assessment is based on Predicted No-Effect Concentrations (PNECs) for the different

compartments which are derived from ecotoxicity data and applying assessment factors. The

assessment factor depends on the type of test performed (acute or chronic), the toxicological

endpoint (effect concentrations (ECs), no-observed effect concentrations (NOECs), etc), and the

number of data and is determined according to the Technical Guidance document (version 2003

chapter 3). The PNECs based on the ecotoxicological data applied for the current risk assessment are

presented in Table E.3.

Table E.3. Predicted no-effect concentrations for ADBAC, DDAC and glutaraldehyde

PNEC Lowest endpoint AF PNEC Test/species

ADBAC

STP EC50: 7.75 mg/L 100 0.0775 mg/L NOEC and EC50 available

(respiration studies)

fresh water NOEC: 4.15 µg/L 10 0.415 µg/L

NOECs are available for three

species belonging to three

trophic levels (fish, Daphnia and

algae). Daphnias are most

sensitive

sediment NOEC: 520 mg/kg

dwt 100 1.13 mg/kg wwt Chironomus tentans study

soil EC10: 74 mg/kg wwt 100 0.74 mg/kg wwt

C12-16-ADBAC was tested on soil

dwelling invertebrates, micro-

organisms and plants. Soil micro-

organisms are most sensitive

DDAC

STP 3h EC50: 17.9 mg/L 100 0.14 mg/L 2 EC50s for STP micro-organisms

(respiration inhibition studies)

freshwater NOEC 0.011 mg/L 10 1,1 µg/L Acute and chronic data available.

Algae are the most sensitive.

sediment NOEC 530 mg/kg

dwt

100 1.15 mg/kg wwt

Based on a chronic study with

midge larvae (Chironomus)

soil EC10 70 mg/kg wwt 50 1.4 mg/kg wwt Two chronic endpoints for

terrestrial organisms. Micro-



60

organisms are most sensitive.

Glutaraldehyde

STP EC50: 51 mg/L 100 0.51 mg/L EC50 from a respiration inhibition

study

fresh water NOEC: 0.025 mg/L 10 2.5 µg/L

Three trophic levels. Based on

the lowest NOEC for algal growth

inhibition

sediment No studies available. Emission to sediment is not expected considering

glutaraldehyde’s low hydrophobicity (Log Kow is -0.33)

soil EC10: 9.2 mg/kgwwt 50 0.184 mg/kg wwt carbon transformation test

Note that data on sediment organisms is not available for glutaraldehyde and therefore have to be

derived from aquatic data by applying equilibrium partitioning. However, PECsediment is also derived by

using equilibrium partitioning from PECfreshwater and therefore the ratio PEC:PNEC for freshwater

covers that of sediment as well. Calculation of PECsediment is therefore not included in the current risk

assessment. However, adsorption to sediment is not expected as the active substance is not

hydrophobic.

7.5 Risk characterisation for the environment

For each relevant compartment, PECs are divided by PNECs. Risks are considered unacceptable when

PEC/PNEC >1.

7.5.1 Aquatic compartment (incl. sediment) and STP

7.5.1.1 Water and sediment organisms and micro-organisms in the STP

Disinfection of transport vehicles

The risk characterisation for the aquatic compartment (freshwater and sediment) indirectly exposed

via a STP are presented in Table E.4 .

Table E.4. PEC and PEC/PNEC ratios for micro-organisms in the STP and freshwater indirectly

exposed due to disinfection of veterinary transport vehicles on the slaughterhouses’’ premises.

STP Fresh water Sediment

PEC (mg/L) PEC/PNEC PEC (mg/L)1 PEC/PNEC PEC (mg/kg

ww)

PEC/PNEC

ADBAC 0.002 0.021 6.15E-06 0.015 0.36 0.315

DDAC 0.002 0.011 1.16E-05 0.011 0.28 0.241

Glutaraldehyde 0.011 0.023 1.15E-03 0.459 0.01 -

Total 0.055 0.485 0.556 1 removal of the active substance(s) by sorption onto suspended matter is included.

Assuming that veterinary transport vehicles are disinfected on the slaughterhouses’ premises and

waste water is purified on-site prior to discharge to the municipal sewer, the application of ADBAC,

DDAC, and glutaraldehyde does not result in unacceptable risks for micro-organisms in the STP and

the receiving freshwater compartment including sediments as the combined PEC:PNEC ratios are

below one. It should be however noted that in absence of data on sediment toxicity, the risk ratios

for glutaraldehyde in freshwater are valid for sediment as well, resulting in a PEC:PNEC ratio slight

above one. However, considering glutaraldehyde’s low sorption profile (see appendix I) and its

irreversible binding to organic matter, sorption onto sediments and risks for sediment living



61

organisms cannot be expected. Therefore, the standards for micro-organisms in the STP and the

aquatic environment are met and no risk mitigation measures are necessary.

Disinfection of stables

The risk characterisation for the aquatic compartment (freshwater and sediment) indirectly exposed

via a STP are presented in Table E.5.

Table E.5. PEC and PEC/PNEC ratios for micro-organisms in the STP and freshwater indirectly

exposed due to disinfection of stables.



ww)

PEC/PNEC

Spraying

ADBAC

Dairy cattle 6.06E-04 0.008 1.21E-05 0.029 7.02E-01 0.621

Beef cattle 3.28E-04 0.004 6.58E-06 0.016 3.80E-01 0.336

Pig farming 4.13E-04 0.005 8.27E-06 0.020 4.78E-01 0.423

Poultry 9.36E-04 0.012 1.88E-05 0.045 1.08E+00 0.960

DDAC

Dairy cattle 6.06E-04 0.004 2.29E-05 0.021 5.47E-01 0.475

Beef cattle 3.28E-04 0.002 1.24E-05 0.011 2.96E-01 0.257

Pig farming 4.13E-04 0.003 1.56E-05 0.014 3.72E-01 0.324

Poultry 9.36E-04 0.007 3.53E-05 0.032 8.45E-01 0.734

Glutaraldehyde

Dairy cattle 2.27E-02 0.044 2.27E-03 0.907 1.78E-02 -

Beef cattle 1.23E-02 0.024 1.23E-03 0.491 9.67E-03 -

Pig farming 1.54E-02 0.030 1.54E-03 0.618 1.22E-02 -

Poultry 3.51E-02 0.069 3.50E-03 1.40 2.76E-02 -

Total

Dairy cattle 0.056 0.957 1.10

Beef cattle 0.03 0.518 0.593

Pig farming 0.038 0.652 0.747

Poultry 0.088 1.48 1.69

Fumigation

ADBAC

Dairy cattle 4.33E-04 0.006 8.69E-06 0.021 5.02E-01 0.444

Beef cattle 1.38E-04 0.002 2.76E-06 0.007 1.60E-01 0.141

Pig farming 1.12E-04 0.001 2.24E-06 0.005 1.29E-01 0.114

Poultry 2.25E-04 0.003 4.51E-06 0.011 2.61E-01 0.231

DDAC

Dairy cattle 4.33E-04 0.003 1.64E-05 0.015 3.91E-01 0.340

Beef cattle 1.38E-04 0.001 5.20E-06 0.005 1.24E-01 0.108

Pig farming 1.12E-04 0.001 4.21E-06 0.004 1.01E-01 0.088

Poultry 2.25E-04 0.002 8.49E-06 0.008 2.03E-01 0.177



62



ww)

PEC/PNEC

Glutaraldehyde

Dairy cattle 1.62E-02 0.032 1.62E-03 0.649 1.28E-02 -

Beef cattle 5.16E-03 0.010 5.16E-04 0.206 4.06E-03 -

Pig farming 4.18E-03 0.008 4.18E-04 0.167 3.29E-03 -

Poultry 8.43E-03 0.017 8.42E-04 0.337 6.63E-03 -

Total

Dairy cattle 0.041 0.685 0.784

Beef cattle 0.013 0.218 0.249

Pig farming 0.01 0.176 0.202

Poultry 0.022 0.356 0.408 1 removal of the active substance(s) by sorption onto suspended matter is included.

Disinfection of stables by spraying results in concentrations that exceed the PNEC for glutaraldehyde

in water (1.48 times max) and quaternary ammonium compounds in sediment (1.69 times max2).

These outcomes must be however considered as worst-case as:

• emission is based on the worst-case dosing of 0.4 L solution/m². Moreover, applying 0.4 L/m² and

considering the surfaces and fractions emitted to the sewer as specified in the ESD results

consequently in 130 to 1000 m³ waste water discharged to the sewer, which clearly negatively

impacts the receiving STP (2000 m³/d). Also note that emission was based on the total stable

surface, while disinfection by spraying is often limited to surfaces that are in direct contact with

animals, i.e. floors and lower parts of walls where the highest infestation may be expected.

Whole stables are for various reasons often disinfected by fumigation;

• stables are disinfected 1 to 7 times per year, exceptions are duck farms which are treated 13

times annually. Therefore, release to the sewer is intermittent for the majority of the stable

types. Elevated concentrations can occur temporarily, in sewers although acute effects cannot be

disregarded as all active substances are considered acutely toxic (H400).

Taken into account the above listened arguments the expected exceeding of the PNEC due to

disinfection of stables by spraying is considered acceptable.

Disinfection by fumigation does not result in unacceptable risks, although fumigation combined with

spraying, which is recommended by specialists, still results in a slight exceeding of the PNEC.

However, the applied ESD assumed that 30 to 50% of the applied disinfectant is released to the

sewer, while the majority is expected to be released to air when stables are ventilated after

treatment.

When residues are released to an IBA, malfunctioning of the waste water treatment system may be

expected as high loads of ADBAC, DDAC, and glutaraldehyde may kill the microbial population as the

system’s volume is limited (3-6 m³) and additional degradation in the sewer is not expected as the

residence time is short and an IBA is not fully loaded with organic material. A precautionary measure

to avoid discharge to an IBA is added to the WG/GA.

Conclusively, disinfection of stables will not result in unacceptable risks for the aquatic environment.

The standards are met and no additional risk mitigation beside a warning for IBAs are necessary.

2 In absence of data on sediment toxicity, the risk ratios for glutaraldeyde in water are valid for

sediment as well and should be therefore added to the aggregated risk coefficient. However, it cannot

be expected that glutaraldehyde adsorbs to sediment.



63

7.5.1.2 Aggregated risk assessment

Because the product is applied at slaughterhouses and on farms both resulting in emission to the

sewer, the environment receives the active substances from different applications and therefore a

cumulative risk assessment should be performed. However, disinfection of stables is done 1-13 times

annually, while transport vehicles are disinfected daily. Therefore, the two intended uses have no

overlap in time and therefore an aggregated risk assessment, i.e. summarising the PEC:PNEC ratios

for all intended uses, is deemed not necessary.

7.5.1.3 Monitoring data (surface water)

Dutch water boards have a well-established programme for monitoring pesticide contamination of

surface waters for which the results are publicly available on-line (www.

bestrijdingsmiddelenatlas.nl). Here, monitoring data are processed in a graphic format aiming to

provide an insight into measured pesticide contamination of Dutch surface waters against

environmental standards. The Pesticide Atlas was used to evaluate measured concentrations of

pesticides in Dutch surface water, but no data are available regarding the presence of the active

substances ADBAC, DDAC and glutaraldehyde in Dutch surface water.

7.5.1.4 Surface water intended for the abstraction of drinking water

Biocidal products with the active substances ADBAC, DDAC and glutaraldehyde have been on the

market for more than three years. The existing active substances are not included in the list of

substances of concern due to their presence in surface water at drinking water abstraction points as

established by VEWIN/Ctgb (2015). In addition, ADBAC, DDAC and glutaraldehyde are not included in

the recommended list of biocides to be monitored for drinking water from surface water (RIVM,

2010), but the RIVM recommends to include quaternary ammonium compounds in general. From the

general scientific knowledge collected by the Ctgb about the product and its active substances, the

Ctgb concludes that there are in this case no concrete indications for concern about the

consequences of this product for surface water from which drinking water is produced, when used in

compliance with the directions for use. Thus the standards for surface water destined for the

production of drinking water are met.

7.5.2 Terrestrial compartment

7.5.2.1 Soil organisms

The risk characterisation for soils resulting from stable disinfection is presented in Table E.6.

Table E.6. PEC derived from the house scenario and PEC/PNEC ratios for soils due to

disinfection of stables. Concentrations are calculated after the 40th manure application on

grassland and 10th application on arable land (ten years) based on nitrogen emissions standards.

Degradation and leaching between two manure events are considered.

Grassland Arable land

PEC (mg/kg wwt) PEC/PNEC PEC (mg/kg wwt) PEC/PNEC

Spraying

ADBAC

Dairy cattle 1.17E-03 0.002 5.83E-04 <0.001

Beef cattle 9.31E-03 0.013 4.86E-03 0.007

Pig farming 6.40E-03 0.009 4.17E-03 0.006

Poultry, including duck

farming 5.52E-03 0.007 4.95E-03 0.007



64



Poultry, excluding duck

farming 3.25E-03 0.004 1.60E-03 0.002

DDAC

Dairy cattle 1.61E-03 0.001 8.06E-04 <0.001

Beef cattle 1.81E-02 0.013 6.72E-03 0.005

Pig farming 1.25E-02 0.009 5.76E-03 0.004


farming 1.08E-02 0.008 6.85E-03 0.005


farming 5.74E-03 0.004 2.22E-03 0.002

Glutaraldehyde

Dairy cattle 5.40E-03 0.029 2.70E-03 0.015

Beef cattle 2.69E-02 0.146 2.25E-02 0.122

Pig farming 1.85E-02 0.1 1.93E-02 0.105


farming 1.59E-02 0.087 2.29E-02 0.124


farming 1.03E-02 0.056 7.42E-03 0.040

Total

Dairy cattle 0.032 0.017

Beef cattle 0.172 0.134

Pig farming 0.118 0.115


farming 0.102 0.136


farming 0.064 0.044

Fumigation

ADBAC

Dairy cattle 8.34E-04 0.001 4.17E-04 <0.001

Beef cattle 2.03E-03 0.003 1.06E-03 0.001

Pig farming 1.73E-03 0.002 1.13E-03 0.002


farming 2.04E-03 0.003 1.83E-03 0.002


farming 8.94E-04 0.001 5.96E-04 <0.001

DDAC

Dairy cattle 1.15E-03 <0.001 5.77E-04 <0.001

Beef cattle 3.95E-03 0.003 1.46E-03 0.001

Pig farming 3.37E-03 0.002 1.56E-03 0.001


farming 3.97E-03 0.003 2.53E-03 0.002



65




farming 1.58E-03 0.001 8.24E-04 <0.001

Glutaraldehyde

Dairy cattle 3.86E-03 0.021 1.93E-03 0.01

Beef cattle 5.86E-03 0.032 4.90E-03 0.027

Pig farming 5.00E-03 0.027 5.22E-03 0.028


farming 5.88E-03 0.032 8.45E-03 0.046


farming 2.84E-03 0.015 2.76E-03 0.015

Total

Dairy cattle 0.023 0.012

Beef cattle 0.038 0.029

Pig farming 0.031 0.031


farming 0.038 0.050


farming 0.017 0.017

Emission to grassland and arable land does not result in unacceptable risks for the terrestrial

environment after ten years of successive manure applications as the PECs are well below the PNECs.

The standards are met and no additional risk mitigation measures are necessary.

7.5.2.2 Non-target arthropods (including bees)

The risk assessment to arthropods is considered to be similar to soil organisms due to their direct

contact with soils. The standards for soil arthropods are therefore met. Because the active

substances are expected to have a non-systemic mode of action, secondary exposure of bees

through pollen is considered negligible. Moreover, direct exposure of bees is unlikely as the product

is applied indoors where bees are absent. Hence, the risk for bees is considered acceptable for the

active substances.

7.5.2.3 Groundwater

Assessment of the drinking water criterion defines that the concentration of the active substance

and the relevant metabolites in groundwater for the preparation of drinking water needs to be < 0.1

µg/L. For the proposed applications, exposure of soil with a potential risk for leaching to

groundwater is expected after the distribution of manure on land.

Leaching of ADBAC and DDAC to groundwater can be excluded because of the high adsorption

characteristics (Koc is >1.0·105 L/kg). However, leaching to groundwater of glutaraldehyde is expected

as this compound is highly mobile and degrades slowly. Therefore, the concentrations in

groundwater were only estimated for glutaraldehyde. The doses and concentrations are listed in

Table E.7.

Table E.7. Concentrations of glutaraldehyde in groundwater. Concentration based on the

worst-case situation (spraying)

Scenario PEC after manure

application (mg/kg wwt)

Dose per manure

application (kg/ha)

Average concentration

closest to the 80th



66

percentile (µg/L)

grassland 0.168 3.28E-02 <0.001

arable land 0.061 7.79E-02 <0.001

No exceeding of the groundwater limit (0.1 µg/L) is expected when manure holding the active

substances is distributed on grassland and arable land. Therefore, the standards for groundwater are

met.

7.5.2.4 Persistence in soil

The half-lives of ADBAC and glutaraldehyde in soils (see appendix I) does not exceed the criteria for

persistence in soils (180 days). The standard for persistence in soils is therefore met.

The half live of DDAC in soils (DT50 212 days at 12°C) does exceed the criteria for persistence in soils

(180 days). Although the standard for persistence in soils is not met, the accompanied risks are

considered acceptable as the PECs are below the PNEC.

7.5.3 Non compartment specific effects relevant to the food chain

7.5.3.1 Bioconcentration

ADBAC and DDAC are surfactants and therefore a normal Kow could not be established. An

experimental BCF (whole fish) is determined at 79 L/kg for ADBAC and 81 L/kg for DDAC, indicating

that ADBAC and DDAC have a low potential for bioaccumulation. Hence the product meets the

standards for bioaccumulation.

As the log Kow of glutaraldehyde is < 3 (see appendix I) and the active substance is not highly

adsorptive (Koc <20000 L/kg in sediment and/or 50000 L/kg in soils), bioconcentration is not expected

according to the trigger values presented in the TGD. The risk for bioconcentration of the proposed

uses is therefore considered not relevant. The standards for bioconcentration are met and no further

assessment of secondary poisoning is deemed necessary.

7.5.3.2 Primary and secondary poisoning of birds and mammals

The low BCFs (see above) indicate that the risk for birds and mammals is low regarding secondary

poisoning. Hence the product meets the standards for the risk to birds and mammals. Primary

poisoning is not expected for the intended uses.

7.5.4 Atmosphere

Criteria for the examination of environmental risks to air are not specified in the form of a numerical

standard. The assessment of potential impacts on air quality is aimed to minimize the risk for

stratospheric ozone depletion. There are no indications that ADBAC, DDAC and glutaraldehyde

contribute to depletion of the ozone layer as the compounds are not listed as ‘controlled substance’

in Annex I of Regulation (EC) No 1005/2009 of the European Parliament. Moreover, AOPwin

calculates for the active substances the following half-lives in air (OH timeframe 24 hrs/day, 0.5×106

OH radicals/cm3):

• ADBAC: 8.8 hours

• DDAC: 8.3 hours

• Glutaraldehyde: 8.2 hours

The calculated half-lives are below the trigger of 2 days, which is used as cut off value to identify

chemicals that could be of potential concern for long range transport through the atmosphere. The

environmental risk to air is therefore considered acceptable.

7.6 Measures to protect the environment (risk mitigation measures)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:286:0001:0030:EN:PDF



67

No risk mitigations were proposed by the applicant. Because release to an individual sewage

treatment plant may result in malfunctioning of the installation, a precautionary measure stating

that residues must be discharged to the manure deposit or municipal sewer will be added. This is

discussed in the next section.

7.7 Overall conclusion for the aspect Environment

An authorisation of a biocide in The Netherlands is only possible when the risks related to the

product application are acceptable. When used in accordance with the legal Instructions for Use

(WG/GA), Virocid F complies with the environmental standards and will not cause unacceptable

effects to the environment provided that inhibition of the functioning of the IBA is prevented. The

following risk mitigation is therefore included in the WG/GA:

NL: Om verminderd functioneren van een Individuele Behandeling Afvalwater (IBA) bij toepassing

van dit middel op de boerderij te voorkomen, dienen afvalresten die het middel bevatten geloosd te

worden op de mestopslag of op de gemeentelijke riolering.

EN: To prevent the inhibition in functioning of an on-site wastewater treatment system (IBA),

possible residues containing the product must be discharged to the slurry pit or to a municipal STP.

The fogging application is withdrawn at the applicant’s request.

8 Conclusion

The fogging application is withdrawn at the applicant’s request.

The applicant has proven that Virocid F under the proposed Legal Conditions for Use and the

Directions for Use (WG/GA), is sufficiently effective and that no unacceptable risk is expected to

human health, the person who uses the product and the environment (Art. 121 jo art. 49 first

paragraph Dutch 2007 Plant Protection Products and Biocides Act).

9 Classification and labelling

The identity of all substances in the mixture that contribute to the classification of the mixture *:

ADBAC, DDAC, gluetaraldehyde

Pictogram: GHS02 Signal word: Danger

GHS05

GHS06

GHS07

GHS08

GHS09

H-statements: H226 Flammable liquid and vapour

H301 Toxic if swallowed.

H314 Causes severe skin burns and eye damage.

H317 May cause an allergic skin reaction.

H330 Fatal if inhaled.

H334 May cause allergy or asthma symptoms or

breathing difficulties if inhaled.

H335 May cause respiratory irritation.

H410 Very toxic to aquatic life with long lasting effects.

P-statements: P210 Keep away from heat, hot surfaces,



68

sparks, open flames and other ignition

sources. No smoking.

P260 Do not breathe

dust/fume/gas/mist/vapours/spray.

P264 Wash … thoroughly after handling.

P273 Avoid release to the environment.

P280 Wear protective gloves/protective clothing.

P301+P310 IF SWALLOWED: Immediately call a POISON

CENTER/doctor/...

P303+P361+P353 IF ON SKIN (or hair): Take off immediately all

contaminated clothing. Rinse skin with water [or

shower].

P304+P340 IF INHALED: Remove person to fresh air and keep

comfortable for breathing.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several

minutes. Remove contact lenses, if present and

easy to do. Continue rinsing.

P342+P311 If experiencing respiratory symptoms: Call a

POISON CENTER/doctor/...

Supplemental Hazard

information:

EHU071 Corrosive to the respiratory tract.

Child-resistant fastening obligatory? Not applicable

Tactile warning of danger obligatory? Not applicable

Explanation:

Pictogram: GHS06 is due to H301and GHS07is due to H335.

H-statements: H301 is assigned in accordance with the calculation described

in Guidance on the application of the CLP Criteria, and based

on exposure to glutaraldehyde in vapour form. H330 and H335

are assigned because of glutaraldehyde.

P-statements: P210 is highly recommended when H226 is assigned.P260 is

proposed by the applicant. For the rest highly recommended P-

statements for the assigned hazard classifications are

proposed.

Other: EUH071 is assigned because of the combination of H314 and

H330.

* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

10 References

Bakker, J. Biociden in oppervlaktewater voor drinkwaterproductie, National Institute of Public Health and the

Environment, RIVM report 601712007, 2010, Bilthoven, The Netherlands.

Clara, M., Scharf, S., Scheffknecht, C., and Gans, O. 2007. Occurrence of selected surfactants in untreated and

treated sewage. Water Research 41, 4339-4348

Database with monitoring data from pesticides in surface water obtained from regional water boards.

http://www.bestrijdingsmiddelenatlas.nl

Lijst met probleemstoffen voor de bereiding van drinkwater uit oppervlaktewater, VEWIN, 2015

http://www.vewin.nl/probleemstoffen

Emission Scenario Document for Product Type 3: Veterinary hygiene biocidal products, JRC Scientific and

Technical Reports, Report nr. EUR 25116 EN, Publications Office of the European Union, Luxembourg, 2011

http://www.vewin.nl/probleemstoffen



69

OECD Series on Emission Scenario Documents Number 14. Emission Scenario Document for insecticides for

stables and manure storage systems. OECD report ENV/JM/MONO(2006)4. Organisation for Economic Co-

operation and Development, Paris, Jan 2006.

Regulation (EC) No 1005/2009 of the European Parliament and the Council of 16 September 2009 on

substances that deplete the ozone layer.

Guidance on the Biocidal Product Regulation. Volume IV: Environment - Part B: Risk Assessment (Active

Substances). European Chemicals Agency, Report no. ECHA-15-G-01-EN, Helsinki, Finland, 2015.

Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens.



70

Appendix I. Input parameters for modelling, environmental assessment

parameter value remarks

ADBAC

molecular weight (g/mole) 359.6 g/mol

Average value. 340.0 – 396.1 g/mol,

depending on alkyl chain length C12 -

C14 - C16

melting point (°C) 150

Compound is a solid at environmental

temperature. Start to decompose at

150°C.

vapour pressure at test temperature

(Pa) 6.03E-04

test temperature vapour pressure (°C) 20

solubility at test temperature (mg/L) 431000 pH 6.5:

test temperature solubility (°C) 20

Henry constant (Pa × m3 × mol-1) 5.03E-07 Calculated

test temperature Henry constant (°C) -

octanol-water partition coefficient

(L/kg) - deemed inaccurate (see Koc)

organic carbon-water partition

coefficient (L/kg) 2658607

The average Koc for sand, sandy loam,

clay loam, silt loam.

characterisation of biodegradability readily biodegradable

half-life for biodegradation in fresh

water at 12°C (days) 15

Default half-life for compounds that

are readily biodegradable according to

the TGD as no degradation studies are

available.

half-life for biodegradation in

sediment at 12°C(days) -

half-life for biodegradation in soil at

12°C (days) 76

half-life for leaching from soil (days)

rate constant for biodegradation in

STP (/d) not relevant

Data for ADBAC is available

demonstrating that an STP effectively

removes 98.5% of the active

ingredients from the waste water

(monitoring study for several

municipal STPs, Clara et al., Water

Research 41, 4399-4348).

half-life in air (hrs) 8.8

Estimated with AOPwin (OH

timeframe 24 hrs/day, 0.5×106 OH

radicals/cm³)

parameter Value Remarks

DDAC

molecular weight (g/mole) 362.1

melting point (°C) 98.2

Compound is a solid at environmental

temperature. Start to decompose at

98.2°C.


(Pa) 5.90E-6


solubility at test temperature (mg/L) 500000



71

test temperature solubility (°C) 20

Henry constant (Pa m³/ mol) 4.27E-9

test temperature Henry constant (°C) 20


(L/kg) -


coefficient (L/kg) 1.1E6


half-life for biodegradation in fresh

water at 12°C (days) 15

Default half-life for compounds that

are readily biodegradable according

to the TGD as no degradation studies

are available.

half-life for biodegradation in

sediment at 12°C(days) -


12°C (days) 212


STP (/d) not relevant

Data for DDAC is available

demonstrating that an STP effectively

removes 98.5% of the active

ingredients from the waste water

(monitoring study for several

municipal STPs, Clara et al., Water

Research 41, 4399-4348).

half-life in air (hrs) 8.3

Estimated with AOPwin (OH

timeframe 24 hrs/day, 0.5×106 OH

radicals/cm³)

parameter value remarks

Glutaraldehyde

molecular weight (g/mole) 100.11

melting point (°C) -33

Compound is a liquid at

environmental temperature.


(Pa) 44 Pure substance


solubility at test temperature (mg/L) miscible

≥ 51.3 g/100ml

test temperature solubility (°C) 20.2+/- 0.1 °C

21 °C

Henry constant (Pa × m3 × mol-1) 0.0086 calculated

test temperature Henry constant (°C) -


(L/kg) 0.47


coefficient (L/kg) 326



12°C (days) 30

Default value for readily

biodegradable compounds


STP (/d) 24

Default value for readily

biodegradable compounds

HET COLLEGE VOOR DE TOELATING VAN ... · EUH071 Bijtend voor de luchtwe gen. 15540 N Virocid F, ......

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