Toelatingsnummer 8960 N

Actisan-5 L  

 

8960 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 VERLENGING TOELATING

 

Gelet op de aanvraag d.d. 26 september 2007 (20071009 TVB) van

 

Veip B.V.

Molenvliet 1

3961 MT  WIJK BIJ DUURSTEDE

 

 

tot verlenging van de toelating voor de biocide, op basis van de werkzame stof natriumdichloorisocyanuraat

 

Actisan-5 L

 

gelet op artikel 122, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Verlenging toelating

1.         De toelating van het middel Actisan-5 L, welke expireert op 1 november 2010 wordt voor de in bijlage I genoemde toepassingen verlengd onder nummer 8960. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.         De toelating geldt tot het tijdstip waarop de lidstaten maatregelen genomen hebben om de nationale toelating in overeenstemming te brengen met het besluit over de werkzame stof van de Europese Commissie..

 

1.2  Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

 

1.3  Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.

 


1.4 Classificatie en etikettering

 

Gelet op artikel 50, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

1.    De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15d van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: Tablet

 

werkzame stof:

gehalte:

natriumdichloorisocyanuraat

85 %

 

 

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof(fen):  

-

 

gevaarsymbool:

aanduiding:

Xn

Schadelijk

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

R22                 -Schadelijk bij opname door de mond.

R31                 -Vormt vergiftige gassen in contact met zuren.

R36/37            -Irriterend voor de ogen en de ademhalingswegen.

R50/53            -Zeer vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

 

Veiligheidsaanbevelingen:

 

S08                 -Verpakking droog houden.

S21                 -Niet roken tijdens gebruik.

S26                 -Bij aanraking met de ogen onmiddellijk met overvloedig water afspoelen en deskundig medisch advies inwinnen.

S36/37/39b     -Draag geschikte beschermende kleding, handschoenen en een beschermingsmiddel voor het gezicht.

S60                 -Deze stof en de verpakking als gevaarlijk afval afvoeren. (Deze zin hoeft niet te worden vermeld op het etiket indien u deelneemt aan het verpakkingenconvenant, en op het etiket het STORL-vignet voert, en ingevolge dit convenant de toepasselijke zin uit de volgende verwijderingszinnen op het etiket vermeldt:

Deze verpakking is bedrijfsafval, mits deze is schoongespoeld, zoals wettelijk is voorgeschreven.

Deze verpakking is bedrijfsafval, nadat deze volledig is geleegd.

Deze verpakking dient nadat deze volledig is geleegd te worden ingeleverd bij een KCA-depot. Informeer bij uw gemeente.)

S61                 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

 

Specifieke vermeldingen:

 

-  

 

 

1)    Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorge­schreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

§         letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

§         hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn
.

 

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

De toelating van het middel Actisan-5 L is laatstelijk bij besluit d.d. 13 oktober 2000 verlengd tot 1 november 2011. Het betreft een aanvraag tot verlenging van de toelating van het middel Actisan-5 L (8960 N), een middel op basis van de werkzame stof natriumdichloorisocyanuraat. De verlenging wordt aangevraagd voor de toelating als middel ter bestrijding of afwering van:

  1. bacteriën (incl. mycobacteriën, doch excl. bacteriesporen) en gisten op oppervlakken, welke in contact komen met eet- en drinkwaren en de grondstoffen hiervoor.
  2. bacteriën (incl. mycobacteriën, doch excl. bacteriesporen) en gisten op oppervlakken, in ruimten bestemd voor het verblijf van mensen.
  3. bacteriën in dierverblijfplaatsen en bijbehorende ruimten.
  4. bacteriën en de volgende virussen in transportmiddelen voor dieren:
    klassieke varkenspest virus, virus van de ziekte Aujeszky en mond- en klauwzeer virus.
  5. micro-organismen in zwembadwater, echter uitsluitend in
    a. therapeutische baden
    b. privé baden, voorzover niet behorend bij hotels, kampeerterreinen, recreatiecentra,
    en internaten en mits het middel zodanig wordt gedoseerd dat:

-          het gehalte beschikbaar chloor gemeten met DPD 1 minimaal 2 mg/l en maximaal
5 mg/l bedraagt.

-          het gehalte cyanuurzuur een concentratie van 100 mg/l niet zal overschrijden.

6.      bacteriën in water in oogstbakken en bloemfusten/-emmers/-vazen.

 

 

2.2 Informatie met betrekking tot de stof

-

 

2.3 Karakterisering van het middel

-

 


2.4 Voorgeschiedenis

De aanvraag is op 26 september 2007 ontvangen; op 1 oktober 2007 en 24 augustus 2010 zijn de verschuldigde aanvraag- en beoordelingskostenkosten ontvangen.

 

2.5  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel
Actisan-5 L op basis van de werkzame stof natriumdichloorisocyanuraat voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, Wet gewasbeschermingsmiddelen en biociden).

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden 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 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 29 oktober 2010

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





dr. D. K. J. Tommel

voorzitter

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 29 oktober 2010 tot verlenging van de toelating van het middel Actisan-5 L, toelatingnummer 8960 N

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als middel ter bestrijding of afwering van:

  1. bacteriën (incl. mycobacteriën, doch excl. bacteriesporen) en gisten op oppervlakken, welke in contact komen met eet- en drinkwaren en de grondstoffen hiervoor.
  2. bacteriën (incl. mycobacteriën, doch excl. bacteriesporen) en gisten op oppervlakken, in ruimten bestemd voor het verblijf van mensen.
  3. bacteriën in dierverblijfplaatsen en bijbehorende ruimten.
  4. bacteriën en de volgende virussen in transportmiddelen voor dieren:
    klassieke varkenspest virus, virus van de ziekte Aujeszky en mond- en klauwzeer virus.
  5. micro-organismen in zwembadwater, echter uitsluitend in
    a. therapeutische baden
    b. privé baden, voorzover niet behorend bij hotels, kampeerterreinen, recreatiecentra,
    en internaten en mits het middel zodanig wordt gedoseerd dat:

-          het gehalte beschikbaar chloor gemeten met DPD 1 minimaal 2 mg/l en maximaal
5 mg/l bedraagt.

-          het gehalte cyanuurzuur een concentratie van 100 mg/l niet zal overschrijden.

6.      bacteriën in water in oogstbakken en bloemfusten/-emmers/-vazen.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

 

De verpakking koel en donker bewaren.

Het middel niet mengen met reinigingsmiddelen.

Verneveling van het middel is niet toegestaan.

Het middel niet in direct contact met dieren laten komen.

 

De te desinfecteren oppervlakken en materialen eerst grondig reinigen. Een daarbij gebruikt reinigingsmiddel afspoelen met schoon water. Overtollig water verwijderen.

 

Bij het desinfecteren zoveel vloeistof gebruiken, dat de oppervlakken gedurende de inwerkingstijd nat blijven.

 

Minimale inwerkingstijd 5 minuten.

 

Behandelde oppervlakken of materialen die met eet- en drinkwaren en de grondstoffen hiervoor in contact kunnen komen dienen na de inwerkingstijd grondig met schoon water te worden nagespoeld.

1 tablet weegt 2,7 gram en bevat 1,5 gram actief chloor.

 


Toepassingsgebieden en doseringen

 

1a.  Apparatuur en materialen, welke al dan niet in contact kunnen komen met eet- en drinkwaren en grondstoffen.
Dosering: 2 tabletten per 10 water.

 

1b.  Melkwinningsapparatuur op de boerderij.
Dosering: 1 tablet per 10 liter water.

 

2.        Voor gebruik in ziekenhuizen en overige instellingen voor gezondheidszorg wordt het middel uitsluitend aanbevolen voor de volgende toepassingen:

 

 

Gebruiksverdunning

Minimale inwerkingstijd

Oppervlakken (wanden, vloeren en meubilair) m.u.v. tbc-afdelingen

1 tablet op 5 liter water

5 min.

Toiletten en overig sanitair

1 tablet op 5 liter water

5 min.

Oppervlakken in tbc-afdelingen

4 tabletten op 1 liter water

5 min.

Oppervlakken en apparatuur in keukens

1 tablet op 5 liter water

5 min.

Was- en beddegoed van tbc-afdelingen

2 tabletten op 5 liter water

1 tablet op 1 liter water

2 tabletten op 1 liter water

6 uur

4 uur

 1 uur

Instrumentarium (m.u.v. cystocopen en andere medische instrumenten): uitsluitend na gebruik en voor reiniging en sterilisatie

1 tablet op 5 liter water

 

 

3.    Dierverblijfplaatsen en bijbehorende ruimten
Dosering:
4 tabletten per 10 liter water

 

4.        Transportmiddelen voor dieren
Dosering: 10 tabletten per 10 liter water

 

De ontsmetting is vooral gericht op de bestrijding van een aantal besmettelijke veeziekten, zoals bedoeld in de Veewet. Voor de ontsmetting moet grondig worden gereinigd.

De ontsmettingsoplossing wordt gemaakt door 10 tabletten per 10 liter water op te lossen. Deze oplossing over de gereinigde oppervlakken (vloeren en wanden) verspreiden en minimaal 5 minuten laten inwerken.

 

Het middel is ook voor de desinfectie van transportmiddelen voor dieren volgens de Beschikking Ontsmetting Motorrijtuigen en Aanhangwagens (no. J. 4510 d.d. 19 juli 1985) toegelaten.

 

5.      Voor gebruik in zwembaden gelden de volgende richtlijnen:
Dit middel is bestemd om zwemwater vrij te houden van bacteriën, algen en andere micro-organismen, die de hygiënische gesteldheid van het water nadelig kunnen beïnvloeden. Het middel is een verbinding van chloor en cyanuurzuur.
De desinfecterende werking berust op het vrijkomen van chloor. Wanneer het middel aan zwemwater wordt toegevoegd, wordt het chloor verbruikt.
Het cyanuurzuur wordt echter niet verbruikt; deze blijft in het water achter.
Wanneer de concentratie van het cyanuurzuur te hoog oploopt zal de werking van het middel teruglopen.
Aangezien de toe te passen hoeveelheden afhankelijk zijn van de mate, waarin het zwemwater wordt belast kan geen algemeen geldende dosering worden aangegeven.
Als richtlijn geldt, dat voor een goede werking een minimale concentratie aan beschikbaar chloor van 2 mg/l nodig is en dat om gezondheidsrisico voor de zwemmers te vermijden, de concentratie aan beschikbaar chloor nooit meer dan 5 mg/l en de concentratie aan cyanuurzuur nooit meer dan 100 mg/l dient te bedragen.
Dit moet regelmatig worden gecontroleerd met daarvoor bestemde testsets. Onder beschikbaar chloor worden die stoffen verstaan die met D.P.D.1 (diëthylparaphenyleendiamine) een kleurreactie geven.
Als richtlijn kan voorts worden aangegeven, dat 1 gram van dit middel per m3 water een beschikbaar chloorgehalte levert van ten hoogste 0,6 mg/l en een gehalte aan cyanuurzuur van 0,65 mg/l.

 

6.      Het middel is bestemd voor het onderdrukken van de bacteriegroei in het water in oogstbakken en bloemfusten/-emmers/-vazen.

Dosering: 1 tablet per 50 liter water (30 mg/l actief chloor)

 

Het middel is in staat om afhankelijk van de temperatuur en de belasting de bacteriegroei gedurende 3 tot 7 dagen effectief te onderdrukken.

 

 

Waarschuwingen:

-        Verneveling van het middel is niet toegestaan.

-        Het middel niet in direct contact met dieren laten komen.

-        Oppervlakken in tbc-ruimten: toepassing alleen met gebruik van geschikte beschermende kleding (overall + wegwerpoverall met capuchon), gezichtsbescherming, handschoenen en laarzen.

-        Alle andere toepassingen (behalve toepassing in zwembaden en in oogstbakken/bloemfusten/-emmers/-vazen): toepassing alleen met gebruik van beschermde kleding (overall), gezichtsbescherming en handschoenen.

-        Geen beschermde kleding of handschoenen nodig bij toepassing in zwembaden in oogstbakken/bloemfusten/-emmers/-vazen

-        Ter voorkoming van nadelige effecten voor bodemorganismen dient de desinfectie van dier transportmiddelen te worden uitgevoerd op locaties met een verharde ondergrond met afvoer naar een riool met aansluiting op de RWZI.

-        Om in het water levende organismen te beschermen dient voorkomen te worden dat zwemwater of afvalwater met middelresten rechtstreeks op het oppervlaktewater wordt geloosd.


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 29 oktober 2010 tot verlenging van de toelating van het middel Actisan-5 L, toelatingnummer 8960 N

 

RISKMANAGEMENT

 

Contents

 

H.1      Introduction                                                                                                                 5

H.2      Identity                                                                                                            6

H.3      Physical and chemical properties                                                                              6

H.4      Analytical methods for detection and identification                                                    6

H.5      Efficacy                                                                                                                      6

H.6      Human toxicology                                                                                                       6

H.7      Environment                                                                                                             22

H.8      Conclusion                                                                                                               33

H.9      Classification and labelling                                                                                       33

H.10    References                                                                                                              37

 

Appendix 1 List of Endpoints sodiumdichloroisocyanurate and trichloroisocyanurate       38

Appendix 2 PNEC derivation                                                                                                45

Appendix 3 Calculation sheets Environment                                                                       48


H.1  Introduction

 

This assessments concerns prolongations of authorisations of Biocidal products based on the active substances sodium dichloroisocyanurate and trichlorocyanuric acid.

 

The use of these products is disinfection (PT2, PT3 and PT4). In table H.1 an overview of the uses is available.

 

Table H.1 Overview of intended use

No.

Product

Area of use envisaged

Dosage a.s.*

 

 

PT2

 

1.

Disochlorine Chloortabletten

Melquick

P3-ansep Chloortabletten

Suma Tab D4

Accommodations for people

0.3 g active chlorine / Liter

2.

Melquick

Stafilex Chloortabletten

Suma Tab D4

Areas/surfaces in hospitals and health care facilities including medical instruments, cleaning equipment, toilets, textiles etc.

1.5 g active chlorine / Liter

6 g active chlorine / Liter
(TB clinics)

3.

Actisan 5L

Melpool 55/G

Melpool 63/G

Melquick

Melpool 90 Tabletten**

Therapeutic baths, private pools (not part of hotels), camping sites, recreation centres or boarding schools

0.005 g active chlorine / Liter ;

0.1 g cyanuric acid / Liter

4.

Actisan 5L

Water in casks, buckets, vases for flowers

0.03 g active chlorine per Liter

 

 

PT3

 

5.

Melquick

P3-Desinfekto

P3-ansep Chloortabletten

Stafilex Chloortabletten

Suma Tab D4

Accommodations for animals and annexes including cleaning equipment

1.6 g active chlorine / Liter

6.

Actisan 5L

P3-Desinfekto

P3-ansep Chloortabletten

Stafilex Chloortabletten

Suma Tab D4

Vehicles for animal transport

1.6 g active chlorine / Liter

 

 

PT4

 

7.

Actisan 5L

Alfa plus

P3-ansep Chloortabletten

Stafilex Combi

Milking equipment on farms, including pipelines, tanks, machinery etc.

0.3 g active chlorine / Liter

8.

Actisan 5L

Disochlorine Chloortabletten

Melquick

P3-Desinfekto

P3-ansep Chloortabletten

Stafilex Chloortabletten

Stafilex Combi

Suma Tab D4

Locations where food and drinks are prepared or stored – surfaces, instruments, systems, cleaning equipment  with or without direct food contact.

0.8 g active chlorine / Liter

* Highest dosage selected from the different uses of the products evaluated for prolongation.

** Product contains Trichloroisocyanuric acid as active substance

 

H.2  Identity

n/a

 

H.3  Physical and chemical properties

n/a

 

H.4  Analytical methods for detection and identification

n/a

 

H.5  Efficacy

n/a

 

H.6  Human toxicology

 

Human health effects assessment active substance

Sodium dichloroisocyanurate (NaDCC or troclosene sodium) is an existing active substance, not included in Annex I of 98/8/EG. An application for inclusion is submitted, for which the United Kingdom is the Reporting Member State.

 

Trichlorocyanuric acid (TCCA or symclosene) is an existing active substance, not included in Annex I of 98/8/EG. An application for inclusion is submitted, for which the United Kingdom is the Reporting Member State.

 

For both active substances, a draft concept CA-report does not exist. Therefore, this assessment is based on the physical chemical and toxicological data as provided in a report on sodium dichloro-s-triazinetrione for the High Production Volume Chemical Challenge Program (sodium dichloro-s-triazinetrione is troclosene sodium, May 2004), published by the US Environmental  Protection Agency (US EPA),  and a report on tichloro-s-triazinetrione for the High Production Volume Chemical Challenge Program (tichloro-s-triazinetrione is symclosene, May 2004), published by the US Environmental  Protection Agency (US EPA) and information from the Ctgb.

 

As both NaDCC and TCCA are chlorinated isocyanurates, and most endpoints are based on read-across studies performed with cyanuric acid, hypochlorite and chlorine, the list of endpoints for both active substances is combined (indicating which substance was used for the study).

 

List of Endpoints from Ctgb



Absorption, distribution, metabolism and excretion in mammals (Annex IIA, point 6.2)

Rate and extent of oral absorption:

CYA (cyanuric acid) 100%

Rate and extent of dermal absorption:

According for physical chemical properties CYA a default value of 100% should be used. However, as is known from rat studies in which CYA was applied dermally and poorly absorbed, a default value of 10% will be used for risk assessment purposes.

There are no data to indicate the degree of dermal absorption of hypochlorite ions. However, the potential of hypochlorite solutions to penetrate the skin is low given its reactivity to proteinaceous material. The absorption has therefore been assessed by assuming a default fraction of 10% that is penetrating the skin. This is considered to be a worst-case assumption based on the indicated low potential for dermal penetration.

Distribution:

Excretion of CYA was mainly urinary.

Potential for accumulation:

No

Rate and extent of excretion:

Excretion of CYA was mainly urinary (> 95% at 5 mg/kg bw) with the remainder being faecal. For oral dosing at 500 mg/kg bw, the proportion of faecal to urinary excretion is variable at 14 – 73% urinary. In studies in humans receiving doses by the oral route, analysis showed that 100% of the ingested CYA was excreted without metabolism by the oral route within 24 hours of ingestion.

Toxicologically significant metabolite

None, chlorinated isocyanurate reduced to chloride ions and cyanuric acid.

Acute toxicity (Annex IIA, point 6.1)

Rat LD50 oral

NaDCC dihydrate:

LD50 = 2094 mg/kg bw (male)

LD50 = 1671 mg/kg bw (female)

TCCA:

LD50 = 787 mg/kg bw (male)

LD50 = 868 mg/kg bw (female)

CYA > 5000 mg/kg bw

Rat LD50 dermal

NaDCC dihydrate: LD50  > 5000 mg/kg

TCCA: LD50 > 2000 mg/kg bw

CYA > 5000 mg/kg bw

Rat LC50 inhalation

NaDCC dihydrate: LC50 > 0.27 mg/L and < 1.17 mg/L when measured gravimetrically

TCCA: LC50 < 0.29 mg/L but > 0.09 mg/L when measured gravimetrically

Skin irritation

Corrosive

Eye irritation

Highly irritating

Skin sensitization (test method used and result)

Not sensitising (0/10 sensitisation rate) Guinea-pig maximisation study.

 

Repeated dose toxicity (Annex IIA, point 6.3)

Species/ target / critical effect

Performed on monosodium cyanurate

Rat, male/ heart and urinary tract/lesions in early parts of 2-year study

Performed on sodium hypochlorite

Rat, decrease body weight and in specific organ weights, associated with some biochemical changes

Lowest relevant oral NOAEL / LOAEL

Monosodium cyanurate

NOAEL 2-year combined toxicity/carcinogenicity study = 371 mg/kg bw/day (males only)

 

Sodium hypochlorite

NOAEL 90-day toxicity study (2 independent studies) = 46.6 mg/kg bw/day (males only)

Lowest relevant dermal NOAEL / LOAEL

NOAEC 0.1% hypochlorite solution

Lowest relevant inhalation NOAEL / LOAEL

NOAEC 0.5 ppm (1 mg/m3) chlorine gas (monkey and human volunteer study)

 

Genotoxicity (Annex IIA, point 6.6)

There is no evidence of genotoxicity of CYA in vitro or in vivo.

 

Carcinogenicity (Annex IIA, point 6.4)

Species/type of tumour

No evidence of carcinogenicity in 2-year combined oral toxicity and carcinogenicity studies in the rat and mouse with monosodium cyanurate or in 24-month-whole year studies in rat with chlorine.

lowest dose with tumours

Not applicable

 

Reproductive toxicity (Annex IIA, point 6.8)

Species/ Reproduction target / critical effect

Monosodium cyanurate rat development/no effect on reproductive targets noted. Maternal toxicity only in teratogenicity study.

 

Studies with chlorine did not show any teratogenic or reproductive effects.

Lowest relevant reproductive NOAEL / LOAEL

NOAEL maternal tox >500 mg/kg

NOAEL teratogen >5000 mg/kg

Species/Developmental target / critical effect

Performed on cyanuric acid

Rat/reproduction/no effect on reproductive targets noted.

Lowest relevant developmental NOAEL / LOAEL

NOAEL = 5375 ppm (470 – 500 mg/kg bw/day males only) offspring

NOAEL adult toxicity (F2 generation) = 190 mg/kg bw/day, males only

 

Neurotoxicity / Delayed neurotoxicity (Annex IIIA, point VI.1)

Species/ target/critical effect

No neurotoxicological effects observed in repeat dose studies. (for both cyanuric acid and chlorine studies)

Lowest relevant developmental NOAEL / LOAEL.

 

 

Other toxicological studies (Annex IIIA, VI/XI)

 

n/a

 

Medical data (Annex IIA, point 6.9)

 

n/a

 

Summary (Annex IIA, point 6.10)

Value

Study

Safety factor

ADI (if residues in food or feed)

CYA = 3.71 mg/kg/day

2-year combined oral toxicity/carcinogenicity

100

 

 

Chlorine = 14.4 mg/kg bw/day

US EPA IRIS

Not applicable

AEL (Operator/Worker Exposure)

CYA = 3.71 mg/kg/day

2-year combined oral toxicity/carcinogenicity

100

 

Sodium hypochlorite = 0.47 mg/kg bw/day

90-days combined oral toxicity

100

Drinking water limit

Chlorine = 25.0 µg/l

Dutch drinking water guidelines

Not applicable

ARfD (acute reference dose)

CYA = 2.0 mg/kg

Rabbit teratology study

100

 

Data requirements active substance

No additional data requirements are identified.

 

6.1                 Human exposure assessment active substance

 

6.1.1           Identification of main paths of human exposure towards active substance from its use in biocidal product

 

Actisan-5L

An application has been submitted for the extension of the authorisation of the biocidal product Actisan-5L (8960N).  Actisan-5L are tablets used as a: private and public health area disinfectant (PT02), for surfaces, equipment, in swimming pools, and in casks/buckets/vases for flowers, veterinary hygiene biocidal product (PT03) and as a food and feed area disinfectant (PT04), containing 85% sodium dichloroisocyanurate as active substance.

 

The formulation Actisan-5L is for professional use

 

ALFA PLUS

An application has been submitted for the extension of the authorisation of the biocidal product ALFA PLUS (11482N).  ALFA PLUS is a water soluble powder used as a food and feed area disinfectant (PT04), containing 9.2% sodium dichloroisocyanurate as active substance.

 

The formulation ALFA PLUS is for professional use.

 

DISOCHLORINE CHLOORTABLETTEN

An application has been submitted for the extension of the authorisation of the biocidal product DISOCHLORINE CHLOORTABLETTEN (11292N).  DISOCHLORINE CHLOORTABLETTEN are tablets used as a: private and public health area disinfectant (PT02), and food and feed area disinfectant (PT04), containing 85% sodium dichloroisocyanurate as active substance.

 

The formulation DISOCHLORINE CHLOORTABLETTEN is for professional use.

 

MELPOOL 55/G

An application has been submitted for the extension of the authorisation of the biocidal product MELPOOL 55/G (10038N).  MELPOOL 55/G are granules used in therapeutic baths or swimming pools for the control of micro-organisms in swimming water (PT02) and contains sodium dichloroisocyanurate (55% active chlorine) as active substance.

 

The formulation MELPOOL 55/G is for both professional and non-professional use.

 

MELPOOL 63/G

An application has been submitted for the extension of the authorisation of the biocidal product MELPOOL 63/G (8081N).  MELPOOL 63/G are granules used in therapeutic baths or swimming pools for the control of micro-organisms in swimming water (PT02) and contains 100% sodium dichloroisocyanurate as active substance.

 

The formulation MELPOOL 63/G is for both professional and non-professional use.

 

MELPOOL 90 TABLETTEN

An application has been submitted for the extension of the authorisation of the biocidal product MELPOOL 90 TABLETTEN (8151N).  MELPOOL 90 TABLETTEN are tablets used in therapeutic baths or swimming pools for the control of micro-organisms in swimming water (PT02) and contains 100% trichlorocyanuric acid as active substance.

 

The formulation MELPOOL 90 TABLETTEN  is for both professional and non-professional use.

 

Melquick

An application has been submitted for the extension of the authorisation of the biocidal product Melquick (8813N).  Melquick are tablets used as a: private and public health area disinfectant (PT02), for surfaces, equipment and in swimming pools, veterinary hygiene biocidal product (PT03) and as a food and feed area disinfectant (PT04), and contains 53% sodium dichloroisocyanurate as active substance.

 

The formulation Melquick is for both professional and non-professional use.

 


P3-ansep chloortabletten

An application has been submitted for the extension of the authorisation of the biocidal product  P3-ansep chloortabletten (6377N).  P3-ansep chloortabletten are tablets used as a:  private and public health area disinfectant (PT02), veterinary hygiene biocidal product (PT03) and feed area disinfectant (PT04), containing 86% sodium dichloroisocyanurate as active substance.

 

The formulation P3-ansep chloortabletten is for professional use.

 

P3-DESINFEKTO

An application has been submitted for the extension of the authorisation of the biocidal product  P3-DISINFEKTO (6571N).  P3-DISINFEKTO are tablets used as a:  veterinary hygiene biocidal product (PT03) and feed area disinfectant (PT04), containing 41% sodium dichloroisocyanurate as active substance.

 

The formulation P3-DISINFEKTO is for professional use.

 

Stafilex Chloortabletten

An application has been submitted for the extension of the authorisation of the biocidal product Stafilex Chloortabletten (6706N).  Stafilex Chloortabletten are tablets used as a: private and public health area disinfectant (PT02), for both surfaces as in swimming pools, veterinary hygiene biocidal product (PT03) and as a food and feed area disinfectant (PT04), containing 85.5% sodium dichloroisocyanurate as active substance.

 

The formulation Stafilex Chloortabletten is for professional use.

 

Stafilex Combi

An application has been submitted for the extension of the authorisation of the biocidal product Stafilex Combi (5390N).  Stafilex Combi is a powder used as a food and feed area disinfectant (PT04), containing 3.4% sodium dichloroisocyanurate as active substance.

 

The formulation Stafilex Combi is for professional use.

 

Suma Tab D4

An application has been submitted for the extension of the authorisation of the biocidal product Suma Tab D4 (7321N).  Suma Tab D4 are tablets used as a: private and public health area disinfectant (PT02), veterinary hygiene biocidal product (PT03) and as a food and feed area disinfectant (PT04), containing 85% sodium dichloroisocyanurate as active substance.

 

The formulation Suma Tab D4 is for professional use.

 

6.1.2           Professional exposure

The professional user can be exposed to the products during:

  • Mixing and loading (including filling and maintenance of feeders of private swimming pools).  The professional user can be exposed to either sodium dichloroisocyanurate (Actisan-5L, ALFA PLUS, DISOCHLORINE CHLOORTABLETTEN, MELPOOL 55/G, MELPOOL 63/G, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4) or trichlorocyanuric acid (MELPOOL 90 TABLETTEN).
  • Course spraying (worst case)/dipping/mobbing/cloth (indicated is the maximum amount of cyanuric acid:  5.5 g/L (worst case), 0.24 g/L, 0.69 g/L, 1.01 g/L,  1.38 g/L, 1.4 g/L, 1.38 g/L, 0.15 g/L and 1.38 g/L & active chlorine: 6.0 g/L (worst case), 0.3 g/L, 0.75 g/L, 1.1 g/L,  1.5 g/L, 1.6 g/L, 1.5 g/L, 0.2 g/L and 1.5 g/L, for respectively Actisan-5L, ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4)
  • Fogging is not a standard use for surfaces in public or private areas (PT02) or for veterinary accommodations/means of transport (PT03) . Furthermore, to include fogging special apparatuses are needed and additional information on how to use the product in combination with the apparatuses (which is not included for all products). Therefore, this risk assessment will not include this use for all products. As fogging induces much smaller particles, which potentially lead to much more exposure than with course spraying, which will not be assessed in this risk assessment the WG/GA needs to include the following restriction: “Fumigation is prohibited”.

 

6.1.3           Non-professional exposure

The non-professional user can be exposed to products containing sodium dichloroisocyanurate (MELPOOL 55/G, MELPOOL 63/G, and Melquick) or products containing trichlorocyanuric acid (MELPOOL 90 TABLETTEN) during filling and maintenance of feeders of private swimming pools.

 

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

 

Disinfection of milking equipment or surfaces in kitchens

Actisan-5L, ALFA PLUS, P3-ansep chloortabletten, P3-DESINFEKTO, and Stafilex Combi are used for the disinfection of milking equipment. Furthermore, Actisan-5L, DISOCHLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4 are used for the disinfection of kitchens, in which food is treated or stored. Therefore, secondary exposure of humans to cyanuric acid, HOCl and disinfection byproducts residues could occur by eating foods from kitchens and/or drinking milk from milking equipment that were treated with these products. However as it is indicated in the WG/GAs that after the treatment milking equipment and/or kitchen surfaces should be rinsed with clean (tap) water, therefore it is not expected that humans can be indirectly exposed to cyanuric acid and chlorine by eating foods from kitchens and/or drinking milk from milking equipment that were treated with these products.

 

Disinfections of accommodations and annexes for animals and/or means of transport for animals

Actisan-5L, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex chloortabletten and Suma Tab D4 are used for the disinfection of accommodations and annexes for animals. Furthermore, Actisan-5L, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex chloortabletten and Suma Tab D4 are also used for the disinfection of means of transport for animals. This means that livestock can be exposed to cyanuric acid, HOCl and disinfection byproducts and that humans can be exposed indirectly by consumption of animal products containing cyanuric acid, HOCl and disinfection byproducts residues. However as it is indicated in the WG/GAs that all products should be kept out of reach from animals, therefore it is not expected that humans can be indirectly exposed to cyanuric acid, HOCl and disinfection byproducts residues by the use of these products in as a animal hygiene product (PT3).

 

Swimming pool

Dermal, oral and inhalation exposure of the general public to cyanuric acid, HOCl and disinfection byproducts will occur during use of a swimming pool (swimming) treated with Actisan-5L, MELPOOL 55/G, MELPOOL 63/G,  and MELPOOL 90 TABLETTEN.

 

6.2                 Human health effects assessment product

 

6.2.1           Toxicity of the formulated product

The toxicity of the formulated product does not change.

 

6.2.2           Data requirements formulated product

No additional data requirements are identified.

 

6.3                 Risk characterisation for human health

 

6.3.1           General aspects

 

AEL/AOELsystemic

The Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AEL based on allometric extrapolation in cases the existing substance is not placed on Annex I. This method takes into account the caloric demand of the species studied and results in a more specific value than the EU-AEL for which in most cases a standard factor of 100 is applied.

 

Cyanuric acid

The calculation of the systemic AEL for chronic is based on the lowest NOAEL of 371 mg/kg bw/day  of two-year study studies with the rat. Calculations from other studies result in higher AELs.

Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

 

Used factors are:

           extrapolation rat à human on basis of caloric demand                                          4

           other interspecies differences:                                                                                2.5

           intraspecies differences: (professional use)                                                           10

           biological availability via oral route:                                                                        100%*

           weight of professional operator/worker:                                                                   60 kg

* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption.

 

AELsystemic: 371 x 1 x 60 / (4 x 2.5 x 10) = 222.6 mg cyanuric acid/day

 

Chlorine (based on read-across van NaOCl)

The calculation of the systemic AEL for semi-chronic is based on the lowest NOAEL of 46.6 mg/kg bw/day  of two subchronic oral toxicity studies with the rat. Calculations from other studies result in higher AELs.

Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

 

Used factors are:

           extrapolation rat à human on basis of caloric demand                                          4

           other interspecies differences:                                                                                2.5

           intraspecies differences: (professional use)                                                           10

           extrapolation subchronic à chronic                                                                        2

           biological availability via oral route:                                                                        36.4%*

           weight of professional operator/worker:                                                                   60 kg

* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption.

 


AELsystemic: 46.6 x 0.364 x 60 / (4 x 2.5 x 10 x 2) = 5 mg sodium hypochlorite/day

 

5 mg sodium hypochlorite/person/day is identical to 0.08 mg sodium hypochlorite/kg bw/day. The available chlorine from NaOCl is equivalent to multiplication of the amount of NaOCl with MW (Cl2)/MW(NaOCl) = 71/74.4 = 0.95. 

 

AELsystemic: 5 x 0.95 = 4.8 mg available chlorine/person/day

 

4.8 mg available chlorine/person/day is identical to 0.08 mg available chlorine/kg bw/day.

 

Local effects and determination of local Acceptable Exposure Level (AELlocal)

Due to its corrosive/irritating properties, sodium dichloroisocyanurate produces local effects after a single exposure (skin and eye irritation) and repeated exposure. Local toxic effects are caused by release of chlorinated species in response to chlorine demand.

 

Sodium dichloroisocyanurate produces free available chlorine, in the form of hyopchlorous acid  (HOCl) as it dissolve in water. A series of rapid equilibria occur involving hypochlorous acid, hypochlorite ion, six chlorinated compounds and four non-chlorinated compounds. As the equilibria involve all of the possible chlorinated isocyanurates, the toxicity of trichloroisocyanuric acid (TCCA), sodium dichloroisocyanurate (NaDCC) and sodium dichloroisocyanurate dihydrate (NaDCC.2H2O) will be virtually equivalent at the same available chlorine concentration. As the free available chlorine (in the form of HOCl) is hydrolysed by reaction with various impurities in the water it is converted into chloride ion and additional free available chlorine is released from the chlorinated isocyanurates in solution.  Once all of the available chlorine has been reduced, the stable reaction products are cyanuric acid (CYA or isocyanuric acid) or its salts (e.g. sodium isocyanurate or disodium cyanurate) and chloride salts. Long-term systemic toxicity is due to the parent species, CYA, which is formed upon degradation.

 

The NOAECs are based on a read across to sodium hypochlorite.

 

Oral exposure

In the RAR of sodium hypochlorite it was concluded that a 2-year drinking water study in rats provided the overall NOAEC of 275 mg available chlorine/L drinking water, equivalent to 409 mg HOCl/L. Applying an overall assessment factor of 10 for inter- and intraspecies variability an oral  limit concentration (AEClocal oral) of 41 mg/L is derived.

 

Dermal exposure

Local effects were observed in repeated dose dermal toxicity studies with NaOCl. On the basis of these studies it was concluded that the NOAEL for repeated dermal exposure to sodium hypochlorite solution was related to its cytotoxicity/irritating properties and was dependent on the concentration of the applied solution. Therefore, skin irritation was seen as a threshold for dermal toxicity. The dermal exposure studies reflected the reversible irritant effects of sodium hypochlorite at the doses tested.

In the RAR of sodium hypochlorite it was concluded that a very conservative NOAEC for repeated effects following dermal exposure to sodium hypochlorite solution is 0.1%, equal to 1 g HOCl/L. Applying an overall assessment factor of 10 for inter- and intraspecies variability a dermal limit concentration AEClocal dermal of 100 mg HOCl/L is derived.

 

Inhalation exposure

In the RAR for sodium hypochlorite inhalation toxicity data on chlorine gas were used as a surrogate assessment of the potential effects of sodium hypochlorite aerosol. In the RAR it was concluded that the NOAEC for repeated exposure to chlorine gas in animal (12 months monkey) as well as human volunteer (single exposure) studies was 0.5 ppm, equivalent to 1 mg/m3. This is more or less the same as the Threshold Limit Value (TLV) for chlorine (Cl2) which is set at 1.5 mg/m3 (for 15 min, ceiling value; Dutch Arbeidsomstandighedensbesluit). For this risk assessment an AELlocal inhalation of 1.5 mg/m3 (15 min, ceiling value) will be used.

 

Furthermore, household bleach is freely available for domestic uses containing 5% sodium hypochlorite

 

6.3.2           Professional users

 

The professional user can be exposed to the products during:

  • Mixing and loading (including filling and maintenance of feeders of private swimming pools).  The professional user can be exposed to either sodium dichloroisocyanurate (Actisan-5L, ALFA PLUS, DISOCHLORINE CHLOORTABLETTEN, MELPOOL 55/G, MELPOOL 63/G, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4) or trichlorocyanuric acid (MELPOOL 90 TABLETTEN).

 

Oral exposure is deemed negligible as the user will not intently eat the product. All products are either granules or in tablet form, therefore inhalatory exposure is negligible and dermal exposure is the main route of exposure. However, as contact time to the product is very short, the dermal exposure is deemed negligible compared to the dermal exposure during application or during use of the swimming pool.

 

  • Course spraying (worst case)/dipping/mobbing/cloth (indicated is the maximum amount of cyanuric acid:  5.5 g/L (worst case), 0.24 g/L, 0.69 g/L, 1.01 g/L,  1.38 g/L, 1.4 g/L, 1.38 g/L, 0.15 g/L and 1.38 g/L & active chlorine: 6.0 g/L (worst case), 0.3 g/L, 0.75 g/L, 1.1 g/L,  1.5 g/L, 1.6 g/L, 1.5 g/L, 0.2 g/L and 1.5 g/L, for respectively Actisan-5L, ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4)

 

The professional user can be inhalatory and dermally exposure during course spraying to cyanuric acid: 5.5 g/L (worst case), 0.24 g/L, 0.69 g/L, 1.01 g/L,  1.38 g/L, 1.4 g/L, 1.38 g/L, 0.15 g/L and 1.38 g/L, for respectively Actisan-5L, ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4. Oral exposure is considered to be negligible as the product is unlikely to reach the mouth directly.

 

The professional user can be inhalatory and dermally exposure during course spraying to active chlorine: 6.0 g/L (worst case), 0.3 g/L, 0.75 g/L, 1.1 g/L,  1.5 g/L, 1.6 g/L, 1.5 g/L, 0.2 g/L and 1.5 g/L, for respectively Actisan-5L, ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4. Oral exposure is considered to be negligible as the product is unlikely to reach the mouth directly.

 

Systemic effects

To calculate professional exposure to Actisan-5L (worst case for both cyanuric acid and active chlorine), the User Guidance for the Technical notes for Guidance on Human Exposure to Biocidal Products is applied. The following points have been taken into consideration:

    • Spraying Model 1 is used: mixing and loading liquids and powders in compression sprayers or dusting applicators, and applying 1 to 3 bar pressure as a coarse or medium spray, indoors and outdoors, overhead and downwards.
    • A task duration of 6 hours
    • A body weight of 60 kg for the professional user

 

Cyanuric acid

 

Table T.1 Internal operator exposure to cyanuric acid and risk assessment for the use of Actisan-5L

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AEL

(mg/day)

Risk-index b

Manual  downward/upward spraying on surfaces

Mixing/

Loading & Applicationc

Respiratory

0.72

222.6

<0.01

Dermal

9.01

222.6

0.04

 

Total

9.73

222.6

0.04

a    Internal exposure was calculated with:

·       biological availability via the dermal route:   10% (default)

·       biological availability via the respiratory route:   100% (worst case)

b    The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c    External exposure is estimated with Spraying Model 1 (TNsG).

d    PPE: gloves and coverall

 

When used according to the WG/GA, it can be concluded that no adverse health effects are expected for the protected (gloves and coverall) professional users to cyanuric acid as a result of the application of Actisan-5L.

The same conclusion applies for ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4, as the diluted concentration of these products is lower compared to Actisan-5L. 

 

Active chlorine

 

Table T.2 Internal operator exposure to active chlorine and risk assessment for the use of Actisan-5L

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AEL

(mg/day)

Risk-index b

without

PPE

with

PPE

without

PPE

with

PPE

Manual  downward/upward spraying on surfaces

Mixing/

Loading & applicationc

Respiratory

0.78

(0.78)

4.8

0.16

(0.16)

Dermal

9.83

0.72

4.8

2.05

0.15

 

Total

10.61

1.50

4.8

2.21

0.31d

a    Internal exposure was calculated with:

·       biological availability via the dermal route:   10% (default)

·       biological availability via the respiratory route:   100% (worst case)

b    The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c    External exposure is estimated with Spraying Model 1 (TNsG).

d    PPE: gloves and coverall

 

When used according to the WG/GA, it can be concluded that no adverse health effects are expected for the protected (gloves and coverall) professional users to active chlorine as a result of the application of Actisan-5L.

As  adverse effects are expected from the unprotected professional users of Actisan-5L, the second worst case is calculated below; P3-DISINFEKTO with an maximum diluted concentration of 1.6 g/L.

 

Table T.3 Internal operator exposure to active chlorine and risk assessment for the use of P3-DESINFEKTO

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AEL

(mg/day)

Risk-index b

Manual  downward/upward spraying on surfaces

Mixing/

Loading & Applicationc

Respiratory

0.21

4.8

0.04

Dermal

2.62

4.8

0.55

 

Total

2.83

4.8

0.59

a    Internal exposure was calculated with:

·       biological availability via the dermal route: 10% (default)

·       biological availability via the respiratory route: 100% (worst case)

b    The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c    External exposure is estimated with Spraying Model 1 (TNsG).

d    PPE: gloves and coverall

 

When used according to the WG/GA, it can be concluded that no adverse health effects are expected for the unprotected professional users to active chlorine as a result of the application of P3-DESINFEKTO.

The same conclusion applies for ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, Stafilex chloortabletten, Stafilex Combi, and Suma Tab D4, as the diluted concentration of these products is lower compared to P3-DISINFEKTO. 

 

Disinfection byproducts

As the sodium hypochlorite RAR describes that the amount of chlorinated by-products discharged (measured as absorbable organic halogens) have been shown to be typically in the order of 0.5% of the available chlorine applied.

6 g/L (Actisan-5L) x 0.5% = 0.03 g/L chlorine.

 

Table T.4 Internal operator exposure to disinfection byproducts and risk assessment for the use of Actisan-5L

 

Route

Estimated internal exposure a (mg /day)

Systemic

NL-AEL

(mg/day)

Risk-index b

Manual  downward/upward spraying on surfaces

Mixing/

Loading & Applicationc

Respiratory

<0.01

4.8

<0.01

Dermal

0.05

4.8

0.01

 

Total

0.05

4.8

0.01

a    Internal exposure was calculated with:

·       biological availability via the dermal route:   10% (default)

·       biological availability via the respiratory route:   100% (worst case)

b    The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c    External exposure is estimated with Spraying Model 1 (TNsG).

d    PPE: gloves and coverall

 

When used according to the WG/GA, it can be concluded that no adverse health effects are expected for the unprotected professional users to disinfection byproducts as a result of the application of Actisan-5L.

The same conclusion applies for ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4, as the diluted concentration of these products is lower compared to Actisan-5L.

 

Local effects

Dermal and upper respiratory tract exposure to active chlorine: 6.0 g/L (worst case), 0.3 g/L, 0.75 g/L, 1.1 g/L,  1.5 g/L, 1.6 g/L, 1.5 g/L, 0.2 g/L and 1.5 g/L, for respectively Actisan-5L, ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4 occurs during course spraying by the professional user.

 

AEClocal dermal is 100 mg HOCl/L is equal to 0.01% NaOCl. As mentioned before, the available chlorine from NaOCl is equivalent to multiplication of the amount of NaOCl with MW (Cl2)/MW(NaOCl) = 71/74.4 = 0.95.  Subsequently, 0.01% NaOCl is equivalent to (0.1 g/L x 0.95 =) 0.095 g/L free chlorine. The maximum doses of all products exceed the AEClocal dermal.

 

Correct use of personal protective equipment (gloves, coverall an face visor) can reduce the dermal exposure results in a sufficient reduction of the exposure to active chlorine during the application of all products except Actisan-5L. For Actisan-5L, 2 layers of clothing (coverall + disposable coverall with hood), boots, gloves and face visor, will result in a sufficient reduction of the exposure to active chlorine during the application.

 

The operator can be inhalatory exposed to chlorine.  AEClocal inhalation is 1.5 mg/m3 chlorine (based on a 15 min occupational health limit). The maximum inhalatory exposure to chlorine per day is: occupational health limit x breathing volume x time = 1.5 mg/m3 x 1.25 m3/h x 0.25 h = 0.46 mg/day. Based on the above used model (Spraying Model 1). In the worst-case scenario (Actisan-5L, maximum diluted concentration of 6.0 g/L active chlorine), the professional will be inhalatory exposed to 0.78 mg/day chlorine (Table 2). This exceeds the maximum inhalatory exposure to chlorine with a factor (0.78/0.46=) 1.7.  However, as produced chloride in solution reacts more easily with other molecules than with chloride itself (which would lead to the formation of  Cl2). The model used overestimates the respiratory exposure to chlorine (a worst-case is shown, depicting the situation where all active chlorine formed, results in the formation of Cl2). Therefore, when used according to the WG/GA, it can be concluded that no adverse health effects are expected for the unprotected professional user after inhalatory exposure to chlorine as a result of the application of Actisan-5L. The same conclusion applies for ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex chloortabletten, Stafilex Combi, and Suma Tab D4, as the diluted concentration of these products is lower compared to P3-DISINFEKTO.

 

On the basis of the above considerations, it can be concluded that the risk for the protected professional user is acceptable (2 layers of clothing (coverall + disposable coverall with hood), boots, gloves and face visor for Actisan-5L and coverall, gloves and face visor for ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4).

 

6.3.3           Non-professional users, including the general public

The non-professional user can be exposed to products containing sodium dichloroisocyanurate (MELPOOL 55/G, MELPOOL 63/G, and Melquick) or a product containing trichlorocyanuric acid (MELPOOL 90 TABLETTEN) during filling and maintenance of feeders of private swimming pools.

 

Oral exposure is deemed negligible as the user will not intently eat the product. All products are either granules or in tablet form, therefore inhalatory exposure is negligible and dermal exposure is the main route of exposure. However, as contact time to the product is very short, the dermal exposure is deemed negligible compared to the dermal exposure during use of the swimming pool.

 

On the basis of these considerations, it can be concluded that the risk for the non-professional user for all products is acceptable.

 

6.3.4           Indirect exposure as a result of use

 

Disinfection of milking equipment or surfaces in kitchens

As it is indicated in the WG/GAs that after the treatment milking equipment and/or kitchen surfaces should be rinsed with clean (tap) water, therefore it is not expected that humans can be indirectly exposed to cyanuric acid and chlorine by eating foods from kitchens and/or drinking milk from milking equipment that were treated with: Actisan-5L, ALFA PLUS, DISOCHLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi and Suma Tab D4. No residues in food and feeding stuffs are expected to arise from the use of MELPOOL 55/G, MELPOOL 63/G, and MELPOOL 90 TABLETTEN.

 

Disinfections of accommodations and annexes for animals and/or means of transport for animals

Actisan-5L, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex chloortabletten and Suma Tab D4 are used for the disinfection of accommodations and annexes for animals. Furthermore, Actisan-5L, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex chloortabletten and Suma Tab D4 are also used for the disinfection of means of transport for animals. This means that livestock can be exposed to cyanuric acid, HOCl and disinfection byproducts and that humans can be exposed indirectly by consumption of animal products containing cyanuric acid, HOCl and disinfection byproducts residues. However as it is indicated in the WG/GAs that all products should be kept out of reach from animals, therefore it is not expected that humans can be indirectly exposed to cyanuric acid, HOCl and disinfection byproducts residues by the use of these products in as a animal hygiene product (PT3).

 

Swimming pool

Dermal and oral exposure of the general public to cyanuric acid and active chlorine will occur during use of a swimming pool treated with Actisan-5L, MELPOOL 55/G, MELPOOL 63/G,  and MELPOOL 90 TABLETTEN. Inhalation exposure can be considered negligible as produced chloride in solution reacts more easily with other molecules than with chloride itself (which would lead to the formation of  Cl2). It is assumed that children will spend much more time in swimming pools than adults, and accordingly will be the most exposed locally and systemically (also compared to the professional/non-professional users). Therefore the exposure as a result of use in swimming pools is only calculated for children.

 

Oral exposure

The following was taken into account:

  • Child (4.5 years) 16.3 kg
  • Chronic AEL systemic child (4.5 years)(more information, see paragraph 6.3.1) :
    •  371 x 1 x 16.3 / (4 x 2.5 x 10) = 60.5 mg cyanuric acid/day
    • 0.08 x 16.3 = 1.3 mg available chlorine/day
  • Oral absorption: 100% for cyanuric acid and 36.4% for free chlorine
  • From instruction of use (from all products):  concentrations of cyanuric acid must not exceed a concentration of 100 mg/L and concentrations free chlorine needs to be at least 2 mg/L and at most 5 mg/L.
  • Intake of 500 millilitres of swimming water.
  • For a 4.5 years old child the exposed area of the body is 7090 cm2. It is assumed that exposure occurs from a layer of 0.1 cm around the skin (based on Technical Guidance Document (2003) and Disinfectant Fact Sheet (Prud’homme de Lodder et al., 2006)). Therefore, the amount of swim water is 709 cm3 or 0.7 L swimming water (equivalent to external exposure of  0.7 L x 100 mg/L = 70 mg cyanuric acid and 0.7 L x 5 mg/L = 3.5 mg available chlorine).

 

Table T.5 Chronic internal exposure to cyanuric acid and active chlorine due to use of swimming pools causing systemic effects

 

Route

Internal exposure (mg /day) a

NL-AEL

(mg/day)

Risk-index b

Swimming pool, cyanuric acid

Child (4.5 years)

Oral

50

60.5

0.84

Dermal

7

60.5

0.12

 

Total

57

60.5

0.96

Swimming pool, free chlorine

Child (4.5 years)

Oral

0.91

1.3

0.70

Dermal

0.35

1.3

0.27

 

Total

1.26

1.3

0.97

Swimming pool,  disinfection byproducts

Child (4.5 years)

Oral

<0.01

1.3

<0.01

Dermal

<0.01

1.3

<0.01

 

Total

<0.01

1.3

<0.01

a    Internal exposure was calculated with:

·       biological availability via the oral route:   100% cyanuric acids  and 36.4% sodium chlorine

·       biological availability via the dermal route: 10% (default for both cyanuric acid and sodium chlorine)

b    The risk-index is calculated by dividing the internal exposure by the AEL.

 

On the basis of the above considerations, adverse health effects after oral and dermal exposure to cyanuric acid, free chlorine and disinfection byproducts can be excluded.

 

Table T.6 Local external exposure to active HOCl due to use of swimming pools causing local effects

Route

external exposure (mg/L or mg/m3)

AEC

(mg/L or mg/m3)

Risk-index b

Swimming pool

Oral (mg HOCl/L)

5a

41 mg/L

0.12

Dermal (mg HOCl/L)

5a

100 mg HOCl/L

0.05

Inhalation (mg HOCl/m3)

<<1b

0.1 mg/m3

<<1

a    Sodium chlorine concentrations is calculated from available chlorine and the multiplication with MW (NaOCl)/MW(Cl2) = 74.4/71 = 1.05.

b    based on the CAR Sodium bromide

 

On the basis of the above considerations, it can be concluded that the risk for the swimmer is acceptable.

 

6.3.5           Combined exposure

All products contain one active substance, either sodium dichloroisocyanurate or trichlorocyanuric acid. However, both active substances lead to cyanuric acid, active chlorine and disinfection byproducts. The combined toxicological effect of these three active substances has not been investigated with regard to repeated dose toxicity.

Possibly, the combined exposure to these active substances may lead to a different toxicological profile than the profile(s) based on the individual substances. After cyanuric acid, the urinary tract is affected, whereas exposure to chlorine affects the liver, spleen and blood cell status.It is therefore not expected that combined exposure to (residues of) all substances (i.e. cyanuric acid, active chlorine and disinfection byproducts) will result in an additional risk above the estimated risks based on the individual substances, when used in accordance to the WG/GA.

 

6.4                 Overall conclusions

Based on the risk assessment, it can be concluded that the risk for the protected professional user no adverse health effects are expected.

Protection should consist of:

  • 2 layers of clothing (coverall + disposable coverall with hood), boots, gloves and face visor for Actisan-5L in TB-clinics
  • Coverall, gloves and face visor for Actisan-5L (in uses other than TB-clinics), ALFA PLUS, DISOCLORINE CHLOORTABLETTEN, Melquick, P3-ansep chloortabletten, P3-DESINFEKTO, Stafilex Chloortabletten, Stafilex Combi, and Suma Tab D4).

 

Furthermore, it can be concluded that for the swimmer no adverse health effects are expected.

 

Moreover, the WG/GA of all products used to disinfect surfaces in private or public areas need to include the following restriction: “fumigation is prohibited”.

 

6.5                 Classification and labelling of the formulation concerning health

 

6.5.1           Proposal for the classification of the active substance

 

Sodium dichloroisocyanurate

Symbol:

Xn

Indication of danger: Harmful

 

Risk phrases

R22

R36/37

Harmful if swallowed.

Irritating to eyes and respiratory system.

 

Trichlorocyanuric acid

Symbol:

Xn

Indication of danger: Harmful

 

Risk phrases

R22

R36/37

Harmful if swallowed.

Irritating to eyes and respiratory system.

 

In Chapter 9 the complete classification and labelling for the products are mentioned.

 

 


H.7  Environment

 

7.1      Introduction

A prolongation of the authorisation is requested for the products Actisan-5 L; Disochlorine chloortabletten, Melquick, MELPOOL 55/G, MELPOOL 63/G, Melpool 90 Tabletten, Suma Tab D4, Stafilex Chloortabletten, Stafilex Combi, P3-Ansep Chloortabletten, P3-Desinfekto and Alfa Plus. Although the authorised products differ in uses, as a whole it concerns applications as Pt2, 3 and 4 disinfectants (see table E.1). Active substances are sodiumdichloroisocyanurate and trichlorocyanuric acid (in Melpool 90 Tabletten only).

 

The active substance sodiumdichloroisocyanurate consists of 2 entries for annex I inclusion: Troclosene sodium (Sodiumdichloroisocyanurate anhydrate = NaDCC) and Sodiumdihloroisocyanurate dihydrate (NaDCC-2H2O), which differ only on the number of water molecules added to the active substance. It is assumed that these water molecules do not participate in the toxicity of Sodiumdihloroisocyanurate.

 

Trichlorocyanuric acid (TCCA or symclosene) also is an existing active substance rather similar to sodiumdichloroisocyanurate, difference is a chlorine molecule replacing the sodium molecule in sodiumdichloroisocyanurate.

 

Sodiumdichloroisocyanurate, sodiumdihloroisocyanurate dihydrate and trichlorocyanuric acid are chlorinated isocyanurates. Their mode of action consists in the release of chlorine and formation of cyanuric acid as carrier. Therefore most endpoints are based on read-across studies performed with cyanuric acid, hypochlorite and chlorine. It is considered acceptable to combine the list of endpoints for all three active substances.

 

Troclosene sodium, sodiumdihloroisocyanurate dihydrate and trichlorocyanuric acid are existing active substances, not included in Annex I of 98/8/EC. For all three active substances applications for inclusion are submitted, for which the United Kingdom is the Reporting Member State. At present a CAR for these substances does not exist.

The Board considers that sodiumdichloroisocyanurate and trichlorocyanuric acid are a bulk chemicals (C157.4; May 2005), therefore accepts publicly available data from IUCLID [2] and other data available at the CTGB [1]. Data are included for the active substance Sodiumdihloroisocyanurate (NaDCC) and its deactivated transformation product cyanuric acid (CYA). It should be noted that these data have NOT been evaluated. There are no data available for the product and this is not considered necessary.

 

The risk assessment for proposed applications with active substance sodiumdichloroiso-cyanurate and trichlorocyanuric acid is done in accordance with Chapter 10 of the RGB [Transition period for guideline 98/08/EC] for products based on active substances which have not been placed on Annex I of Directive 98/8/EC.

An overview of the endpoints is included in the Appendix 1 with a profile of the active substance sodiumdichloroiso-cyanurate (dihydrate), trichlorocyanuric acid, the major transformation product cyanuric acid and hypochlorite. In Appendix 2 an overview of the PNEC values is presented. In appendix 3 an overview of all ESD calculations is included.

In paragraph 7.2 a qualitative and quantitative exposure assessment, followed by a risk assessment presented in 7.3.

 

The products evaluated for prolongation are tablets or granulates for professional use only, with the exception of applications in pools (professional and non-professional users). The intended use is described in table E.1., see Chapter 1.

 


7.2      Environmental exposure assessment product

 

7.2.1        Chemistry and/or metabolism

The chlorinated isocyanurates hydrolyse rapidly upon addition to an aqueous environment  (DT50 <1 minute) releasing free available chlorine. As the free available chlorine is consumed by reaction with organic matter and inorganic ions (chlorine demand), chloride ion is produced. The major stable degradation product is cyanuric acid (CYA).

As residual product of the oxydation process free available chlorine can be build in organic matter forming chlorinated organic micro pollutants. These chlorinated organic micro pollutants are not addressed in the environmental risk assessment, considering that these residuals are formed in small quantities (<10% of the applied chlorine).

 

7.2.2        Distribution in the environment

Emission routes

The following lifecycle stages are considered:

 

 

Various phases in the life cycle of a product may cause emissions and environmental exposure. Emissions from active substance production and product formulation are considered less relevant compared to emissions from the application phase, in service and waste phase of the product.

 

Application, in-service and waste phase

Emission to the environment during the application phase is only relevant for outdoor use at farms for the disinfection of means of transport. All other applications, including swimming pools are expected to have no emission to the environment during the application and in-service phase.

 

Waste phase

Emissions to the environment may occur during the waste phase when residuals of the use biocidal product are removed:

- Indoor application of the product in solutions to surfaces, materials or equipment after the prescribed contact time results in the removal of residuals to the sewer with release to the STP.

- For indoor applications at farms it is assumed that treated water with residuals of the biocidal product is removed to Manure Storage Systems. Although the emission scenarios prepared by the EU indicate that emission to the STP will occur. Release to and the consequential exposure of the STP is not considered relevant for Dutch farming as discharge of manure to the sewage system or on surface water is not permitted.

- Applications to swimming pools may result in removal of swimming water with residuals of the biocidal product to the sewer. For larger swimming pools (outdoors) and private pools, however, also direct emission to surface water occurs after drainage of the water.

- In the waste phase the treatment of water of casks, buckets, vases for flowers (4) (Actisan-5 L) will result in emission to the sewer.

Emission to the secondary compartments surface water/sediment via STP effluent depends on a number of factors such as transformation / degradation of the a.s. and its transformation products.

 

Emission to air may occur during and after application of the product due to ventilation.

 

Emission to soil is considered negligible for applications with emission to the STP, but relevant for applications at farms with direct emission to soil and secondary emission to soil after spreading of manure with residuals of the product. Also during the disinfection of animal transport vehicles at farms emission to soil may occur.

 

The foreseeable routes of entry into the environment during the application, in-service and waste phase are listed in Table E.2.

 

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

 

 

Environmental compartments and groups of organisms exposed

No

Use scenario

STP

Freshwater*

Saltwater*

Soil**

Air

Birds and mammals

 

PT2

 

 

 

 

 

 

1.

Accommodations for people

++

+

-

-

(+)

(+)/-

2.

Areas/surfaces in hospitals and health care facilities including medical instruments, cleaning equipment, toilets etc.

++

+

-

-

(+)

(+)/-

3.

Therapeutic baths, private pools (not part of hotels), camping sites, recreation centres or boarding schools

++

++

-

-

(+)

(+)/-

4.

Water of casks, buckets, vases for flowers

++

+

-

-

-

(+)/-

 

PT3

 

 

 

 

 

 

5.

Accommodations for animals and annexes

-

-

-

+

(+)

(+)/-

6.

Vehicles for animal transport

-

-

-

++

(+)

(+)/-

 

PT4

 

 

 

 

 

 

7.

Milking equipment on farms, including pipelines, tanks, machinery etc.

-

-

-

+

(+)

(+)/-

8.

Locations where food and drinks are prepared or stored – surfaces, instruments, cleaning equipment  with (pt4) or without food contact (pt2)

++

+

-

-

(+)

(+)/-

++       Compartment primarily exposed

+                     Compartment secondarily exposed (surface water from STP discharge, vertebrates eating contaminated fish and soil after removal of manure with residuals of the product over grassland and arable land)

(+)       Compartment potentially exposed

-          Compartment not exposed

(+)/-     The compartment is potentially exposed or not. This depends on the specific use and the             characteristics of the active substance

*           Including sediment

**         Including groundwater, bees and non-target arthropods

 

It is assumed that for indoor applications with emission to the sewer or manure storage only the major transformation product cyanuric acid is relevant. The active substance and active chlorine is consumed before reaching the STP or soil.

Exposure of the aquatic and/or soil compartment to the active substance / active chlorine is relevant only for applications with outdoor use or direct emission to aquatic compartment, such as outdoor treatment of applications in swimming pools and means of animal transport.

 

It should be noted that the several uses may result in simultaneous emission to the STP and surface water. Therefore an accumulative risk assessment is considered relevant.

 

Scenarios and models used for PEC calculations

Predicted Environmental Concentrations (PEC) for indoor and outdoor applications were calculated in accordance with the scenarios from OECD Emissions Scenario Documents (ESDs) for Private area and public health area disinfectants (RIVM, 2001), Draft final ESDs for Product Type 3: Veterinary hygiene biocidal products, for Product Type 4: Disinfectants used in food and feed areas, Pt18 Insecticides for Stables and Manure Storage Systems. No EU scenario is available for the treatment of water for flowers. Instead as worst case assumption is used possible use of this product at flower auctions. Use in flower greenhouses, transporters, sellers and consumers are expected to be more diffuse, resulting in lower concentrations.

 

Calculations were performed with excel sheets and EUSES 2.1. Input values, calculations and results and can be found in appendix 3.

The ESD for Stables and Manure Storage Systems assumes that the emission of the active substance after application in animal housing occurs mainly via the distribution of manure (agricultural land) and waste water (STP). The fractions of the active substance that are emitted to those streams are determined by the type of pest, the type of product, the methodology of product application, and the type of housing and manure storage system.

The ESD distinguishes 18 types of animal housings. Each type has its own characteristics with respect to size, number of animals and fractions of the active substance that are emitted via manure and/or waste water. All available housing types were included in the present calculations. Considering all stable types makes it possible to define restrictive measures per animal category or stable type in case a potential risk is identified.

Manure is spread on arable land once a year and on grassland 4x a year. The PIEC after a single application of manure of land or grassland is calculated for both scenarios using an excel sheet conform the ESD on treatment of manure in stables. For grasslands, the PEC after four applications is calculated in addition to the PIEC (conform the ESD).

 

7.2.3        PEC in surface water, sediment and STP

Cyanuric acid has only minor sorptive characteristics (Koc 108 L/kg). Therefore it is considered that risks for the sediment are covered by the risk assessment  for the aquatic compartment.

 

For the application in swimming water of private pools Melpool 55/G, Melpool 63/G, Melpool 90 Tabletten and Melquick direct emission to surface water may occur after drainage of the treated swimming water. For uses such as public pools, spas/hot tubs emission to the sewer and STP will occur. In table E-3 two tiers are included: tier 1 is the environmental concentration in surface water if the swimming water discharged immediately after treatment. In the second tier deactivation of the active chlorine is taken into account a 1 day deactivation period and assuming a DT50 of 4 hours. The latter value is considered realistic considering that complete drainage of a swimming pool is carried out only if the swimming water is aged and of low quality due to contaminants in the water. It is expected that in such a water active chlorine is deactivated more rapidly.

 

Table E-3. PECs of active chlorine and cyanuric acid for surface water, Pt 2.02 after direct emission (max. concentration 5 mg active chlorine/L and 100 mg/L cyanuric acid)

Use type

Dilution factor

Drainage

 

 

PECaquatic, intermittent
 
[mg active chlorine/L]

PECaquatic, intermittent

[mg cyanuric acid/L]

Tier 1: Discharge immediate after treatment

Private pools

2

2.5

50

Public pools

4

1.25

25

Tier 2: Discharge after 3 day deactivation assuming a DT50 of 4 hours

Private pools

2

9.54E-6

50

Public pools

4

4.77E-6

25

Scenario 2 = Van der Poel and Bakker (2002)

 

A direct quantitative risk assessment for the use of sodiumdichloroisocyanurate in water of casks, buckets, vases for flowers is not possible, as no information is available on the quantities used.  The product can be used in flower greenhouses, auctions, flower transporters, sellers and consumers. It is expected that most emissions of treated water will occur to the sewer with connection to a STP. Worst case application probably is the use in flower auctions. As for the emission from flower auctions the following data were derived from CBS: Discharge volume of 4 auctions per year: 3258.835 m3/year. Assuming 200 emission days results in a discharge per auction of 4.1 m3/day. Assuming that 90% of the water is treated results in a daily emission of 111 g cyanuric acid. In the default STP and TGD river this will result in a PECsr of 33 mg/L.

 

For the proposed uses in private and public health area disinfectants (PT2), Veterinary hygiene biocidal products (PT3) and food and feed area disinfectants (PT4) indirect emission to surface water will occur. For this emission route the assessment is restricted to the major transformation product cyanuric acid.

 

Table E-4. Use of sodium dichloroisocyanurate (expressed as kg active chlorine /d) and PECs (mg/l) of cyanuric acid for STP and surface water after indirect emission

No

Use scenario

Emission (kg/d)

PECSTP

(mg/L)

PECsurface water (µg/L)

 

PT2

 

 

 

1.

Accommodations for people (industrial and public)

0.023

0.0067

0.67

2.

Areas/surfaces in hospitals and health care facilities including medical instruments, cleaning equipment, toilets etc.

0.21

0.061

6.1

3.

Therapeutic baths, private pools (not part of hotels), camping sites, recreation centres or boarding schools

2

0.59

59

4.

Water of casks, buckets, vases for flowers

4.7

1.37

137

 

PT3

 

 

 

5.

Accommodations for animals and annexes

-

-

-

6.a

Vehicles for animal transport

-

-

-

 

PT4

 

 

 

7.

Milking equipment on farms, including pipelines, tanks, machinery etc.

0.042

0.012

1.2

8a.

Locations where food and drinks are prepared or stored – surfaces, instruments, cleaning equipment*

0.92

 

 

0.27

27

8b

Beverage industry

0.99

0.29

29

6.b

vehicles for animal transport (central disinfection)

2.62

0.76

76

*: sum of amounts used in slaughter houses and kitchens/canteens, without pre-treatment

**: Use in beverage industry

 

 

As described above all types of uses will result in emissions to the STP. The Simple treat model in EUSES 2.1 was used to derive PECs. The distribution and degree of removal of cyanuric acid in the STP is determined by the processes of biodegradation, adsorption onto sludge, removal due to sludge withdrawal and volatilisation, and was estimated using the following physical/chemical parameters (Derived from EPIwin):

- Henrys Law constant (3.79E-10 Pa*m³/mol)

- LogPow (1.95)

- biodegradability (inherently biodegradable)

 

7.2.4        PEC in air

See section air under risk characterisation for the environment.

 

7.2.5        PEC in soil and groundwater

The exposure assessment of cyanuric acid is based on the application of manure to soil and the subsequent leaching to groundwater. Additionally a soil exposure assessment is carried out for the disinfection of animal transport vehicles at farms resulting in a direct emission to soil of product residues including active chlorine and cyanuric acid.

 

The risk assessment of soil is based on a worst case scenario that cyanuric acid did not degrade in manure/slurry during storage. This is reasoned considering that in the Netherlands, the period of storage in certain animal housings is < 2 weeks and therefore there is a very short time period available for degradation.

 

The highest PIEC soil in arable land and grassland 19.8 and 27.2 μg/kg soil see Table E.5.

 

Table E.5. PIECsoil and groundwater for cyanuric acid for arable and grassland after treated manure application and PECsoil for active chlorine and cyanuric acid after the disinfection of a animal transport vehicle at a farm, excluding degradation.

Scenario

Category

Active chlorine

Cyanuric acid

 

 

Soil

(mg/kg soil)

Soil

(mg/kg soil)

Porewater (mg/L)

Treated manure from stables#

Arable land

 PIEC soil after one application

0

1.98E-02

1.63E-4

 

Grassland

PIECsoil  after 4 applications

0

2.76E-02

2.27E-4

Animal transport vehicles

Soil after 1 disinfection treatment

15.8

13.8

-

# Worst case maximum PIECsoil is directly after manure application on arable land;

 

The fate and behaviour profile for cyanuric acid infers that it has a high potential to reach groundwater as this compound has been shown to be mobile in soil. 4 scenarios of animal housings showed exceedance of the groundwater criteria for drinking water by a factor of 1.6 to 2.3. It should be noted, that, although not quantified, there are indications that cyanuric acid rapidly degrades under anaerobic conditions. Considering the close range to acceptability of the drinking water criterion for the 4 scenarios, fulfilment of the criterion for 14 scenarios, the uncertainties involved in the emission scenarios and the fact that biodegradation is not included in the calculations, the risk for groundwater used for the production of drinking water is considered sufficiently addressed and considered acceptable.

 

7.2.6        Primary and secondary poisoning of birds and mammals

The estimated log Pow of sodiumdichloroisocyanurate, trichloroisocyanuric acid, active chlorine and cyanuric acid are -0.05, not available and 1.95, respectively. Which are far below the relevant trigger value of 3 as stated in the TGD. It is concluded that the potential for sodiumdichloroisocyanurate, trichloroisocyanuric acid and its major transformation products to bio-accumulate is low and a risk of secondary poisoning does not exist.

Due the type of use of the sodiumdichloroisocyanurate and trichloroisocyanuric acid containing products primary poisoning is not expected to be of any relevance.

 

7.2.7        Monitoring data

Monitoring data of sodiumdichloroisocyanurate, trichloroisocyanuric acid, active chlorine and cyanuric acid in water, soil and air compartments are not available.

 

7.3 Risk characterisation for the environment

In the risk assessment presented in this chapter a comparison is made between the predicted environmental concentration (PEC), presented in the chapter above, and the Predicted No Effect Concentration (PNEC). This PNEC is derived in Appendix 2 from data available in the list of endpoints (Appendix 1). For the different uses described above PEC/PNEC ratios are calculated. If the PEC/PNEC ratio exceeds 1 then there is an unacceptable risk.

 

7.3.1 Aquatic compartment (incl. Sediment) and STP

 

STP

The proposed use may result in an emission of the active substance to the sewage system, however, based on the rapid degradation, with a half life less than 2 minutes in activated sludge, it can be concluded that all active chlorine formed from sodiumdichloroisocyanurate or trichloroisocyanuric acid has been decomposed by reductants present in the sewage drainage system. The active chlorine will not reach the STP. Emission of the major transformation product cyanuric acid to the STP will occur after use of sodiumdichloroisocyanurate or trichloroisocyanuric acid containing products. The cyanuric acid concentration in the STP can only be derived from the amount of product used.

 

Table E.6. PEC/PNEC ratios of cyanuric acid for STP after emission (PNECSTP cyanuric acid = 34 mg/L)

No

Use scenario

PECSTP

(mg/L)

PEC/PNEC

 

PT2

 

 

1.

Accommodations for people (industrial and public)

0.0067

<0.001

2.

Areas/surfaces in hospitals and health care facilities including medical instruments, cleaning equipment, toilets etc.

0.061

0.002

3.

Therapeutic baths, private pools (not part of hotels), camping sites, recreation centres or boarding schools

0.59

0.017

4.

Water of casks, buckets, vases for flowers

1.37

0.04

 

PT3

 

 

5.

Accommodations for animals and annexes

-

-

6.a

vehicles for animal transport

-

-

 

PT4

 

 

7.

Milking equipment on farms, including pipelines, tanks, machinery etc.

0.012

<0.001

8a.

Locations where food and drinks are prepared or stored – surfaces, instruments, cleaning equipment*

0.27

0.008

8b

Beverage industry

0.45

0.008

6.b

vehicles for animal transport (central disinfection)

0.76

0.022

 

Accumulative exposure

 

0.099

*: sum of amounts used in slaughter houses and kitchens/canteens, without pre-treatment

 

No unacceptable risks for micro-organisms in the STP are expected (even if all emissions are combined to one STP). Therefore the standard for micro-organisms in the STP is met for all products and applications.

 

Water and sediment organisms

The risk of direct emission of formed active chlorine and cyanuric acid to surface water formed after the application of sodiumdichloroisocyanurate or trichloroisocyanuric acid to swimming water is assessed in table E.7.

 

Table E.7 PEC/PNEC ratios of active chlorine and cyanuric acid in surface water after direct emission of treated pool water

No

Use scenario

PECsurface water (µg/L)

Acute PNEC (µg/L)

PEC/PNEC

Discharge immediately after treatment

 

active chlorine

2500

0.3

8333

 

cyanuric acid

50,000

6600

7.6

 

Combination toxicity

 

 

8340

Discharge after 3 days deactivation assuming a DT50 of 4 hours

 

active chlorine

0.0095

0.3

0.03

 

cyanuric acid

50,000

6600

7.6

 

Combination toxicity

 

 

7.63

 

Direct emission to surface water of treated swimming water from will result in a short term risk for aquatic organisms. Deactivation of the active chlorine will result in a lower risk, but the risk is still unacceptable for the emission of cyanuric acid remaining in the emitted swimming water.

 

An overview of the risks due to indirect emission of sodiumdichloroisocyanurate or trichloroisocyanuric and its major transformation products to water and sediment organisms after discharge of wastewater through a STP is presented below.

 

No direct or indirect exposure of STP, surface water and sediment is expected from indoor applications of the product of the product in animal housings.

 

Table E-8. PEC/PNEC ratios of cyanuric acid in surface water after indirect emission via the STP (PNEC cyanuric acid = 660 µg/L).

No

Use scenario

PECSW

(µg/L)

PEC/PNEC

 

PT2

 

 

1.

Accommodations for people (industrial and public)

0.67

0.001

2.

Areas/surfaces in hospitals and health care facilities including medical instruments, cleaning equipment, toilets etc.

6.1

0.009

3.

Therapeutic baths, private pools (not part of hotels), camping sites, recreation centres or boarding schools

59

0.089

4.

Water of casks, buckets, vases for flowers

137

0.21

 

PT3

 

 

5.

Accommodations for animals and annexes

-

-

6.a

Vehicles for animal transport

-

-

 

PT4

 

 

7.

Milking equipment on farms, including pipelines, tanks, machinery etc.

1.2

0.002

8a.

Locations where food and drinks are prepared or stored – surfaces, instruments, cleaning equipment*

27

0.041

8b

Beverage industry

29

0.044

6.b

Vehicles for animal transport (central disinfection)

76

0.12

 

Accumulative exposure

 

0.52

*: sum of amounts used in slaughter houses and kitchens/canteens, without pre-treatment

 

No unacceptable risks for aquatic organisms in surface water are expected (even if all emissions are combined to one STP discharging to surface water). Therefore the criterion for aquatic organisms in water is met for all products and applications.

 

Monitoring data (surface water)

There are no data available in the Pesticide Atlas regarding the presence of sodiumdichloroiso-cyanurate or trichloroisocyanuric and major transformation products active chlorine and cyanuric acid in surface water.

 

All products evaluated here are on the market for more than 3 years (First product is authorised since 18-January-1991). From the general scientific knowledge collected by the Ctgb about the product, its active substance and major transformation products, the Ctgb concludes that there are 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. The Ctgb does not expect an exceeding of the drinking water criterion when the product is used conform the Legal instructions for Use. The standards for surface water destined for the production of drinking water are met.

 

7.3.2    Atmosphere

Criteria for the examination of environmental risks to air are not specified by a numerical standard. Therefore, effects on air quality are only taken into account when adverse effects are predicted.  Currently, the assessment of potential impacts on air quality is aimed to minimise the risk for stratospheric ozone depletion.

Within the NL framework, the following approach is used to test for ozone depletion:

The WGB admission requirements for air can be considered as generic, without a quantitative assessment. As possible effects to the air quality are qualitatively determined only, the assessment is restricted to the evaluation of the potential of the active substances regarding their potential to deplete ozone in the earth’s stratosphere (ozone layer).

The FOCUS air working group developed a guidance methodology to determine the potential of a substance for ozone depletion. The following issues are considered relevant:

1.      the atmospheric life time of a substance should be long enough to transport the substance to the atmosphere;

2.      The substance contains one or more of the following substituents: F, Cl of Br;

3.      Substances containing N and S are relevant in stratospheric ozone depletion (e.g. N2O);

Exemplified substances are CFCl3, tetrachloromethane, HCFC142b, Halon 1211 and methyl bromide with a atmospheric life time of 2 to 50 year.

 

As sodiumdichloroisocyanurate and trichloroisocynuric acid fulfils one of these criteria, a potential risk for ozone depletion may occur. It depends on the type of use, emission route and possible other degradation characteristics, whether ozone depletion is relevant.

A source of chlorine is from the use of sodiumdichloroisocyanurate and trichloroisocynuric acid in indoor disinfection treatments and in swimming pools. When released, this chlorine is rapidly converted to forms that dissolve in water and therefore are removed from the lower atmosphere. Such chlorine never reaches the stratosphere in significant amounts [WHO reporting}.

Therefore the proposed application of the active substances sodiumdichloroisocyanurate and trichloroisocynuric acid meet the standards for air.

 

7.3.3    Terrestrial compartment

Soil organisms

The risk assessment is targeted to the risks for soil organisms after exposure to treated manure and direct emission to soil of product residues during disinfection treatment of animal transport vehicles on farms.

 

Table E.9. PIECsoil and PEC/PNEC for cyanuric acid for arable and grassland after treated manure application and PECsoil and PEC/PNEC for active chlorine and cyanuric acid after the disinfection of a animal transport vehicle at a farm.

Scenario

Category

Active chlorine

Cyanuric acid

 

 

Soil

(mg/kg soil)

PEC/PNEC

Soil

(mg/kg soil)

PEC/PNEC

Treated manure from stables#

Arable land

 PIEC soil after one application

-

-

1.98E-02

0.001

 

Grassland

PIECsoil  after 4 applications

-

-

2.76E-02

0.015

Animal transport vehicles

Soil after 1 disinfection treatment

15.8

**

13.8

7.7

# Worst case scenario: maximum PIECsoil directly after manure application on arable land and grassland;

** Risk could not be determined because no PNECsoil could be derived for active chlorine.

 

PECsoil/PNECsoil quotients were below 1 in all 18 scenarios for transformation product cyanuric acid. Emission of residues of the products Actisan 5L, P3-Desinfekto, P3-ansep Chloortabletten, Stafilex Chloortabletten and Suma Tab D4 to soil at farms after the disinfection of animal transport vehicles, however, will result in a risk for soil organisms. Therefore risk mitigation measures are required for these products: disinfection of animal transport vehicles is restricted to locations with a hard standing with a discharge to a sewer system connected to a STP. Setting in place these risk mitigation measures, risks for soil organisms are considered acceptable for all uses.

 

Non-target arthropods (including bees)

The exposure of bees is considered negligible as bees are not considered to forage in animal housings or on manure treated land. Soil dwelling arthropods are considered to be covered by the risk assessment for soil organisms as cyanuric acid is assumed to have a non-specific mode of action.

All other uses as described in table E.1 are not expected to result in exposure of non-target arthropods (including bees). Therefore risks for non-target arthropods including bees are considered acceptable for all uses.

 

Groundwater

Assessment of the drinking water criterion takes place according to the RGB. This means that the concentration of the active substance and relevant metabolites in groundwater for the preparation of drinking water needs to be < 0.1 μg/L.

The PECgw derived using the equilibrium partitioning method from the PEC soil, estimated that for arable and grasslands, the cut off value of 0.1 µg/L would be exceeded for all animal housings and that a higher tier risk assessment was necessary.

 

Also PEARL predicted for cyanuric acid groundwater concentrations over 0.1 μg/L on basis of the same input parameters as EUSES. Assuming that cyanuric acid is inherently biodegradable. Considering that drinking water standard is exceeded only in 4 of the 14 scenarios by maximal 2.6, the scenarios are rather worst case and that the WHO concluded that cyanuric acid will degrade more rapidly under anaerobic conditions resulting in no risk, it is concluded that the use for the disinfection of stables fulfils the criteria for water used for the production of drinking water.

 

Persistence in soil

Sodiumdichloroisocyanurate and trichloroisocynurate react rapidly with organic and inorganic material in soil and will not persist. Both actives meet the standards for persistence. No soil degradation studies are available for major transformation product cyanuric acid. Cyanuric acid is considered to be not readily biodegradable in laboratory studies (OECD, 1999). However, it does biodegrade in the environment, in both soil and ambient water systems, in which it degrades to carbon dioxide and ammonia so that it does not accumulate in the environment. The standards for persistence in soil are met.

 

7.3.4    Non compartment specific effects relevant to the food chain

Bioconcentration and secondary poisoning

As the log Kow values are < 3 for sodiumdichloroisocyanurate and cyanuric acid (-0.05 and 1.95, respectively), and as active chlorine is a reactive short living substance, a risk for bioconcentration and biomagnification is not expected (conform the biomagnification trigger value proposed for Kow in the TGD).

The risk for bioconcentration and secondary poisoning in the proposed use is therefore considered not relevant. The standards for bioconcentration and secondary poisoning are met.

 

Primary poisoning of birds and mammals

The proposed use will not result in direct exposure of birds and mammals and thus the risk for the primary poisoning is considered acceptable.

 

7.4       Measures to protect the environment (risk mitigation measures)

Additional measures to protect the environment (risk mitigation measures) are required for applications related to the direct discharge of swimming water. The following mitigation measure is required for the application in swimming water of private and public pools of Melpool 55/G, Melpool 63/G, Melpool 90 Tabletten and Melquick: “To protect aquatic organisms direct discharge of the treated swimming water must be prevented”.

 

 “Om in het water levende organismen te beschermen dient voorkomen te worden dat zwemwater of afvalwater met middelresten rechtstreeks op het oppervlaktewater wordt geloosd.”

 

Additional measures to protect the environment (risk mitigation measures) are required for applications related to the direct emission to soil after disinfection of animal transport vehicles at farms. The following mitigation measure is required for Actisan 5L, P3-Desinfekto, P3-ansep Chloortabletten, Stafilex Chloortabletten, Suma Tab D4: “To prevent adverse effects for soil organisms disinfection of animal transport vehicles is restricted to locations with a hard standing with a discharge to a sewer system connected to a STP”.

 

“Ter voorkoming van nadelige effecten voor bodemorganismen dient de desinfectie van dier transportmiddelen te worden uitgevoerd op locaties met een verharde ondergrond met afvoer naar een riool met aansluiting op de RWZI.”

 

7.5 Overall conclusion

It can be concluded that:

  1. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate, meets the standards for aquatic and sediment organisms.
  2. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for microorganisms in STP
  3. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for the production of drinking water from surface water.
  4. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for the production of drinking water from shallow groundwater and surface water.
  5. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for the air compartment.
  6. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for persistence in soil.
  7. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for soil organisms.
  8. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the risks for non-target arthropods including bees.
  9. the  proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for bioconcentration
  10. the proposed application of the active substance sodiumdichloroisocyanurate and trichloroisocyanurate meets the standards for primary and secondary poisoning of birds and mammals.

 

Based on the available data, it can be concluded that Actisan-5 L, Disochlorine Chloortabletten, Melquick, Melpool 55/G, Melpool 63/G, Melpool 90 Tabletten, Suma Tab D4, Stafilex Chloortabletten, Stafilex Combi, P3-ansep chloortabletten, P3-Desinfekto, Alfa Plus, when used in accordance with the proposed label (WG/GA) complies with the environmental standards and will not cause unacceptable effects on the environment.

 

Data requirements

There are no additional data required.

 

CONSULTED LITERATURE SOURCES

Ctgb dossier

 

EUSES 2.1.1

 

Pearl 3.3.3

 

ESD

for PT2, 3 and 4

WHO

[3] WHO, 2007. Sodium Dichloroisocyanurate in Drinking-water - Background document for development of WHO Guidelines for Drinking-Water Quality

 

 

H.8.  Conclusion

When the products Alfa Plus, Actisan-5 L, Disochlorine Chloortabletten, Melpool 55/G, Melpool 63/G, Melpool 90 Tabletten, Melquick, P3-Ansep Chloortabletten, P3-Desinfekto, Stafilex Chloortabletten, Stafilex Combi and Suma Tab D4 are used in accordance with the WG/GA 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 Pesticides and Biocides Act).

 

 

H.9.  Classification and labelling

Actisan 5-L, 8960 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N

Indication of danger:

Harmful,

Dangerous for the environment

R phrases

R22

R31

R36/37

R50/53

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to eyes and respiratory system.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S26

 

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

Disochlorine chloortabletten, 11292 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N

Indication of danger:

Harmful,

Dangerous for the environment

R phrases

R22

R31

R36/37

R50/53

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to eyes and respiratory system.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S26

 

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

MELQUICK 8813 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N

O

Indication of danger:

Harmful,

Dangerous for the environment

Oxidizing

R phrases

R8

R22

R31

R36/37

R50/53

Contact with combustible material may cause fire.

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to eyes and respiratory system.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S26

 

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

P3-ansep chloortabletten, 6377 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N

O

Indication of danger:

Harmful,

Dangerous for the environment

Oxidizing

R phrases

R8

R22

R31

R36/37

R50/53

Contact with combustible material may cause fire.

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to eyes and respiratory system.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S26

 

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

P3-desinfecto, 6571 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N,

O

Indication of danger:

Harmful,

Dangerous for the environment

Oxidizing

R phrases

R8

R22

R31

R37/38

R41

R50/53

Contact with combustible material may cause fire.

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to respiratory system and skin.

Risk of serious damage to eyes.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S26

 

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

Stafilex Chloortabletten, 6706 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N

Indication of danger:

Harmful,

Dangerous for the environment

R phrases

R22

R31

R36/37

R50/53

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to eyes and respiratory system.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S22/23-NL

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

Do not breath dust and spray.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

Suma Tab D4, 7321 N

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

Xn,

N

O

Indication of danger:

Harmful,

Dangerous for the environment

Oxidizing

R phrases

R8

R22

R31

R36/37

R50/53

Contact with combustible material may cause fire.

Harmful if swallowed.

Contact with acids liberates toxic gas.

Irritating to eyes and respiratory system.

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

S8

S21

S22/23-NL

S36/37/39b

 

S60

 

S61

Keep container dry.

When using do not smoke.

Do not breath dust and spray.

Wear suitable protective clothing, gloves and face protection.

This material and its container must be disposed of as hazardous waste.

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

The current classification and labelling, which are prepared in conformity with Directive 1999/45/EC, can be maintained for the products:

Alfa Plus, Melpool 55/G, Melpool 63/G, Stafilex Combi and Melpool 90 Tabletten.

 

 

H.10  References

No references are available.


Appendix 1 List of Endpoints sodiumdichloroisocyanurate and trichloroisocyanurate

This List of endpoints contains studies not evaluated by the CTGB as these are currently under assessment as part of the EU BPD Annex I inclusion process.

 

Profile of active substance

Identity

Chemical name (CA)

Troclosene sodium = Sodiumdihloroisocyanurate anhydrate (NaDCC)

Sodiumdihloroisocyanurate dihydrate (NaDCC-2H2O)

Trichloroisocyanuric acid (TCCA),

CAS No

2893-78-9

51580-86-0

87-90-1

Molecular formula

C3C12N3O3.Na

C3Cl2N3O3.2H2O.Na

C3Cl3N3O3

Molecular mass

Troclosene sodium:                                         219.95

Sodium dichloroisocyanurate dihydrate:     255.98

TCCA                                                            232.41

Structural formula

 

Troclosene sodium         TCCA

Sodium dichloroisocyanurate dihydrate

CYA (transformation product):

 

Physical and chemical properties

Appearance (state purity)

White granular solid with chlorine odour

Specific gravity

Sodium dichloroisocyanurate dihydrate: 1.97 g/mL at 25°C

CYA: 1.75 g/mL

Vapour pressure (in Pa, state temperature)

< 0.06 Pa at 20 ºC

Henry’s law constant

5.28 E-05 atm-m3/mole fraction (calculated)

5.35  Pa-m3/mole

TCCA <0.002 Pa at 20°C (equivalent to OECD 104)

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

The active substance hydrolyses rapidly upon addition to water. The results of the study therefore reflect the hydrolysis reaction and the resultant solubility of the hydrolysis products.

Troclosene sodium:

15000 mg/L (10°C)

20000 mg/L (20°C)

28000 mg/L (30°C)

 

Sodium dichloroisocyanurate dihydrate:

17000 mg/L (10°C)

22500 mg/L (10°C)

31000 mg/L (10°C)

Partition coefficient (log POW)

Log Pow = -0.0556 TCCA: Log Pow = 0.94

The substance is a salt which hydrolyses rapidly in water (t1/2 < 1 second) forming polar products which are insoluble in octanol and soluble in water, which suggests that the Pow would be very low.

The active substance reacts with octanol..

 

Route and rate of degradation in water

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

Chlorinated isocyanurate t½ < 1 minute

CYA t½ > 30 days at 25% at all environmentally relevant pH
0% after 30 days [2]

Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolites

CYA t½ > 30 days at 25°C in water

Readily biodegradable (yes/no)

TCCA or NaDCC – No, inherently biodegradable

CYA – No.

CYA degrades rapidly under anaerobic conditions (soils, sediments) or under conditions of low dissolved oxygen. (100% degradation in activated sludge (2.5 mg/l O2) in 8 hours)

Biodegradation in seawater

Not applicable

Non-extractable residues

Not applicable

Distribution in water / sediment systems (active substance)

TCCA or NaDCC undergoes rapid hydrolysis to form available chlorine in the form of HOCl and cyanuric acid.

Distribution in water / sediment systems (metabolites)

Available chlorine will be rapidly reduced by organic matter, the stable reaction products are CYA or its salts and chloride salts.

CYA degrades under a wide variety of natural conditions, and particularly well in systems of either low or zero dissolved oxygen, such as anaerobic activated sludge and sewage, soils, mud’s, etc. The overall degradation reaction is hydrolysis, initially to carbon dioxide and ammonia. Since no net oxidation occurs, CYA exerts no primary biological oxygen demand. However, eventual nitrification of the ammonia would exert its usual biological oxygen demand. Organisms degrading CYA under anaerobic conditions do not require acclimatisation. In highly aerobic media, CYA resists biodegradation.

 

Route and rate of degradation in soil

Mineralization (aerobic)

Not performed – not applicable to the proposed product types.

Laboratory studies (range or median, with number of measurements, with regression coefficient)

Not performed

Field studies (state location, range or median with number of measurements)

Not performed

Anaerobic degradation

CYA degrades readily under a wide variety of natural conditions, and particularly well in systems of either low or zero dissolved oxygen, such as anaerobic activated sludge and sewage, soils, muds (Saldick J (1974) 100% degradation in farm soil in 23 days.

Soil photolysis

No data available

Non-extractable residues

No data available

Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)

No data available

Soil accumulation and plateau concentration

CYA degrades readily under a wide variety of natural conditions, and particularly well in systems of either low or zero dissolved oxygen, such as anaerobic activated sludge and sewage, soils, mud’s, etc. The overall degradation reaction is hydrolysis, initially to carbon dioxide and ammonia. Since no net oxidation occurs, CYA exerts no primary biological oxygen demand. However, eventual nitrification of the ammonia would exert its usual biological oxygen demand. Organisms degrading CYA under anaerobic conditions do not require acclimatisation.

 

Adsorption/desorption

Ka , Kd

Kaoc , Kdoc

pH dependence (yes / no) (if yes type of

dependence)

Performed on CYA

 

Kd = 0.114 – 0.622

Koc = 8 – 150

 

No.

TCCA or NaDCC is rapidly reduced by reaction with inorganic species in soil. Mobility of CYA decreases with decreasing organic matter.

 

Fate and behaviour in air

Direct photolysis in air

No absorbance in the UV at < 290 nm

Indirect photolysis with OH radicals (TCCA/NaDCC/CYA) = 43 hours with an overall OH rate constant of 3.00 E-12 cm3/molecule-sec (calculated, EPIWIN v 3.12)

Quantum yield of direct photolysis

No data available

Photo-oxidative degradation in air

Latitude: .............                             Season: .................          DT50..............

Volatilization

The active substance is not volatile; however, available chlorine and chloride will be released when the active substance is in the aqueous environment, therefore small emissions of chlorine compounds (HOCl and chloramines) to the air compartment would be expected during use of the substance. These compounds are very short-lived due to their high reactivity, therefore there is insignificant risk. The lifetime of HOCl in the stratosphere under photolysis conditions is at most 30 min. The amount of chloride released from use of these compounds is insignificant compared to natural sources.

Monitoring data, if available

Soil (indicate location and type of study)

No data available

Surface water (indicate location and type of study)

No data available

Ground water (indicate location and type of study)

No data available

Air (indicate location and type of study)

Monitoring data from a single manufacturing site has shown that the actual exposure is 0.1 ppm (0.145 mg/m3) chlorine.

 

Chapter 5:       Effects on Non-target Species

Toxicity data for aquatic species (most sensitive species of each group) CYA

 

Species

Time-scale

Endpoint

Toxicity

 

Fish

 

Salmo gairdneri

96h

LC50

>2100 mg/L of CYA measured/nominal

 

Salmo gairdneri

21 days

NOEC

= 756 mg/L of CYA measured/nominal

 

Invertebrates

 

Daphnia magna

48 hr

EC50

> 1000 mg/L of CYA measured/nominal

 

Daphnia magna

21 day

NOEC

= 121 mg/L of CYA measured/nominal

 

Algae

 

Selenastrum capricornutum

96 hr

EC50

= 655 mg/L of CYA measured/nominal

 

N. pelliculosa

96 h

NOEC

= 945 mg/L of CYA measured/nominal

 

Microorganisms

 

Activated sludge, predominantly domestic sewage

3 h

EC50

= 3402 mg/L of CYA

 

Toxicity data for aquatic species (most sensitive species of each group)  NaDCC

 

Species

Time-scale

Endpoint

Toxicity

 

Fish

 

Salmo gairdneri

96 h

LC50

0.22 mg/L [2]

 

Invertebrates

 

Daphnia magna

48 hr

EC50

0.196 µg/L of NaDCC anhydrous nominal [2]

 

Daphnia magna

48 hr

EC50

0.28 mg/L [2]

 

 

 

 

 

 

Algae

 

No data available

 

 

 

 

Microorganisms

 

No data available

 

 

 

 

Toxicity data for aquatic species (most sensitive species of each group)  Trichloroisocyanuric acid (TCCA)

Species

Time-scale

Endpoint

Toxicity

Fish

Salmo gairdneri

96h

LC50

0.24 mg/L of TCCA nominal

Lepomis macrochirus

96h

LC50

> 0.23 mg/L of TCCA

nominal

Oryzias latipes

96h

LC50

0.3 mg/L TCCA [2]

Invertebrates

Daphnia magna

48 hr

NOEC

= 0.21 mg/L of TCCA measured/nominal

Daphnia magna

48 hr

NOEC

0.17 of TCCA measured/nominal

Daphnia magna

48h

EC50

0.21 mg/L TCCA [2]

Algae

Chlorella pyrenoidosa. Euglena gracilis, Scenedesmus obligauus

96 hr

EC50

= 655 mg/L of CYA measured/nominal

0.5 mg/L TCCA nominal

Microorganisms

Activated sludge, predominantly domestic sewage

3 h

EC50

= 59 mg/L of TCCA

 


Effects on sediment dwelling organisms

Acute toxicity to

CYA is not toxic to chironomid. NOEC = 756 mg/kg wwt

Effects on earthworms or other soil non-target organisms

Acute toxicity to ………………………………….

CYA is not toxic to earthworms. NOEC = 756 mg/kg wwt

Reproductive toxicity to  …………………………

No data available

Effects on soil micro-organisms

Nitrogen mineralization

No data available

Carbon mineralization

No data available

 

Effects on terrestrial vertebrates

Acute toxicity to mammals

NaDCC dihydrate:

LD50 = 2094 mg/kg bw (male)

LD50 = 1671 mg/kg bw (female)

TCCA: LD50 = 787 mg/kg bw (male)

CYA > 5000 mg/kg bw

Reproductive toxicity to mammals

Performed on cyanuric acid

NOEL = 5375 ppm (470 – 500 mg/kg bw/day males only) offspring

NOAEL adult toxicity (F2 generation) = 190 mg/kg bw/day, males only

Acute toxicity to birds

No data available

Dietary toxicity to birds

NaDCC is not toxic to birds. LD50 = 1766 mg/kg

TCCA is not toxic to birds. LD50 = 1630 mg/kg

Reproductive toxicity to birds

No data available

 

Effects on honeybees

Acute oral toxicity

No data available

Acute contact toxicity

No data available

 

Effects on other beneficial arthropods

Acute oral toxicity

No data available

Acute contact toxicity

No data available

Acute toxicity to ………………………………..

No data available

Bioconcentration

Bioconcentration factor (BCF)

The chlorinated isocyanurates react rapidly in aqueous solutions releasing free available chlorine, therefore the Log Pow of any of the chlorinated isocyanurates are expected to be low. The calculated Log BCF for NaDCC is 0.286 (BCF = 1.932). If absorbed, the available chlorine will readily react with proteins in tissue to form oxidized proteins, chloride ion and CYA. The measured Log Pow of the CYA is -1.31 giving a calculated Log BCF of 0.500 (BCF = 3.162). Therefore, there is no potential for bioaccumulation.

Depuration time (DT50)

                      (DT90)

Not measured

Level of metabolites (%) in organisms accounting for > 10 % of residues

None

 

Input parameters for cyanuric acid in EUSES and PEARL

Parameter

Input

Unit

d/s/o*

Molecular weight