Toelatingsnummer 11453 N

Score 250 EC  

 

11453 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 VEREENVOUDIGDE UITBREIDING

 

Gelet op de aanvraag d.d. 18 september 2008 (20080793 VUG) van

 

Stichting Trustee Bijzondere Toelatingen

Hogeweg 16

2585 JD  'S-GRAVENHAGE

 

 

tot uitbreiding van de gebruiksdoeleinden van de toelating van als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden het gewasbeschermingsmiddel, op basis van de werkzame stof difenoconazool

 

Score 250 EC

 

gelet op artikel 31, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

1.   Het gebruiksgebied van het middel Score 250 EC wordt met ingang van datum dezes

      uitgebreid met de toepassing in de onbedekte teelt van vlas, rode biet, Chinese broccoli,

      boerenkool, Chinese kool en Oosterse bladkolen en pastinaak. Voor de

      gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.   Het middel wordt toegelaten 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 29, 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 15e 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: vloeistof

 

werkzame stof:

gehalte:

difenoconazool

250 g/l

 

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

N

Milieugevaarlijk

 

 

Waarschuwingszinnen: 

 

R51/53            -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

Veiligheidsaanbevelingen:

 

S21                 -Niet roken tijdens gebruik.

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

 

Specifieke vermeldingen:

 

DPD01            -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

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:

 

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

 

b. 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.

 

c.      bij het toelatingsnummer een cirkel met daarin de aanduiding W.6.

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Score 250 EC (11453 N), een middel op basis van de werkzame stof difenoconazool. De aanvraag is gedaan door Stichting Trustee Bijzondere Toelatingen.

Het middel is bij besluit van 30 augustus 1996 reeds toegelaten als schimmelbestrijdingsmiddel. Het middel is bij dit besluit toegelaten 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. Met onderliggende aanvraag wordt een vereenvoudigde uitbreiding van de toelating gevraagd voor toepassing in de onbedekte teelt van vlas, rode biet, Chinese broccoli, boerenkool, Chinese kool en Oosterse bladkolen, koolraap, knolraap en pastinaak.  

Voor de aspecten fysische en chemische eigenschappen/analysemethoden en werkzaameheid is de vereenvoudigde uitbreidingsprocedure gevolgd. Concreet betekent dit dat het aspect werkzaamheid niet is beoordeeld. Met betrekking tot de aspecten fysische en chemische eigenschappen/analysemethoden zijn alleen de residu-analysemethoden voor plantaardige en dierlijke produkten beoordeeld.

 

2.2 Informatie met betrekking tot de stof

De werkzame stof difenoconazool is per 1 januari 2009 geplaatst (met een peer-review in een later stadium) op Annex I van gewasbeschermingsrichtlijn 91/414/EEG. Het betreft een zogenaamde groene stof. De Europese beoordeling vindt plaats voor 31 december 2010.

 

2.3 Karakterisering van het middel

Score 250 EC bevat 250 g/l difenoconazool. Difenoconazool behoort tot de groep van de triazolen en is een DMI fungicide (DeMethyl Inhibitor). Het remt de ergosterol biosynthese van het celmembraan.

Difenoconazool werkt systemisch en wordt acropetaal en translaminair in de plant en het blad getransporteerd. Difenoconazool werkt preventief en curatief.

 

2.4 Voorgeschiedenis

De aanvraag is op 22 september 2008 ontvangen; op 16 september 2008 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 10 maart 2009 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2); te weten de werkinstructies RGB (voor toxicologie en milieu) en in de RGB aangeduide (delen van de) toepasselijke versie van de HTB ( in dit geval versie 1.0)

 

3.1  Fysische en chemische eigenschappen

Gelet op de aard van het verzoek is dit aspect niet beoordeeld. De fysische en chemische eigenschappen wijzigen niet (zie Hoofdstuk 2, Physical and Chemical Properties, in Bijlage II bij dit besluit).

 

3.2  Analysemethoden

Gelet op de aard van het verzoek zijn alleen de residu-analysemethoden voor plantaardige en dierlijke produkten beoordeeld (zie Hoofdstuk 3, Methods of Analysis, in Bijlage II bij dit besluit).

 

3.3  Risico voor de mens

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar (artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en biociden).
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.

Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij dit besluit.

 

3.4  Risico voor het milieu

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

 

3.5  Werkzaamheid

Het aspect werkzaamheid is niet beoordeeld omdat het hier een derdenuitbreiding betreft.

 

3.6  Eindconclusie

Bij gebruik volgens het gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is de uitbreiding voor de gevraagde doeleinden van het middel Score 250 EC op basis van de werkzame stof difenoconazool voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, eerste lid, 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, 5 februari 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. 5 februari 2010 tot vereenvoudigde uitbreiding van de toelating van het middel Score 250 EC, toelatingnummer 11453 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als schimmelbestrijdingsmiddel in de onbedekte teelt van:

a)      suikerbieten en voederbieten

b)      winterkoolzaad

c)      vlas

d)      appels en peren

e)      boerenkool, Oosterse bladkolen, Chinese broccoli, sluitkool, Chinese kool, bloemkool, broccoli  en spruitkool

f)        rode biet

g)      knolselderij en bleekselderij

h)      bospeen, waspeen, winterwortel, pastinaak

i)        asperges

en de bedekte en onbedekte teelt van:

j)        snijselderij en peterselie

 

 

-          In de teelt van vlas is maximaal 1 toepassing toegestaan.

-          In de teelt van suikerbieten, voederbieten, winterkoolzaad, broccoli, Chinese broccoli, bloemkool, rode biet,  snijselderij en peterselie zijn maximaal 2 toepassingen toegestaan.

-          In de teelt van appels en peren zijn maximaal 4 toepassingen toegestaan.

-          In de overige vermelde gewassen zijn maximaal 3 toepassingen toegestaan.

 

Om in het water levende organismen te beschermen is de toepassing in de teelt van appel en peer in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan na

1 mei, indien gebruik gemaakt wordt van één van de volgende combinaties:

-          er gespoten wordt met een tunnelspuit en een maximale hoeveelheid spuitvloeistof van 1000 liter per ha, of

-          er gebruik wordt gemaakt van een windhaag op de rand van het rijpad en éénzijdige bespuiting van de laatste bomenrij, of

-          er in de eerste 20 meter grenzend aan het oppervlaktewater gebruik wordt gemaakt van een venturi-dop in combinatie met een éénzijdige bespuiting van de laatste bomenrij en een maximale hoeveelheid spuitvloeistof van 1400 liter per ha.

 

Op percelen die grenzen aan watergangen is toepassing in de onbedekte teelt van suikerbiet, voederbiet, winterkoolzaad, vlas, boerenkool, Oosterse bladkolen, Chinese broccoli, sluitkool, Chinese kool, bloemkool, broccoli, spruitkool, rode biet, knolselderij, bleekselderij, snijselderij, peterselie, bospeen, waspeen, winterwortelen, pastinaak en asperges uitsluitend toegestaan met gebruik van doppen uit de driftreductieklasse 75 %.




 

Veiligheidstermijnen

De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan:

-14 dagen voor boerenkool, Oosterse bladkolen, Chinese broccoli, Chinese kool, bloemkool,  broccoli, bospeen, waspeen, winterwortel, pastinaak, snijselderij en peterselie

- 21 dagen voor rode kool, savooie kool, witte kool, spitskool, spruitkool, knolselderij en bleekselderij

- 28 dagen voor suikerbieten, voederbieten, appels, peren en rode biet

 

De toepassing door middel van een luchtvaartuig is niet toegestaan.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

 

B.

GEBRUIKSAANWIJZING

 

 

Algemeen

Score 250 EC is een schimmelbestrijdingsmiddel met de werkzame stof difenoconazool en behoort tot de chemische groep van de azolen. Score 250 EC is een systemisch middel dat opgenomen wordt door de vegetatieve delen van de plant en heeft zowel een preventieve als een curatieve werking. Het middel dient te worden toegepast door middel van een gewasbehandeling.

 

De toelating in de teelt van vlas, boerenkool, Oosterse bladkolen, Chinese broccoli, Chinese kool, pastinaak, rode biet, knolselderij, bleekselderij, snijselderij en peterselie is tot stand gekomen op basis van een derdenuitbreiding via de Stichting Trustee Bijzondere Toelatingen.

Hiervoor worden geen gegevens over werkzaamheid en fytotoxiciteit beoordeeld. Het gebruik van dit middel in deze teelten geschiedt daarom voor eigen risico van de teler.

 

Resistentiemanagement

Indien nodig Score 250 EC afwisselen met middelen met een ander werkingsmechanisme, die een werking hebben tegen de geclaimde organismen, om resistentie of kruisresistentie tegen te gaan. Bij voorkeur opeenvolgende behandelingen uitvoeren en daarna afwisselen met middelen met een ander werkingsmechanisme.

 

 

Toepassingen

 

Suikerbieten en voederbieten, ter bestrijding van bladvlekkenziekte (Cercospora beticola).

Een behandeling uitvoeren zodra aantasting wordt waargenomen. Indien nodig kan de toepassing worden herhaald. Maximaal 2 bespuitingen per seizoen uitvoeren.

Dosering: 0,4 liter middel per ha.

Een behandeling tegen bladvlekkenziekte heeft ook een werking tegen Ramularia beticola,  roest (Uromyces betae) en meeldauw (Erysiphe betae)

 

Winterkoolzaad, ter bestrijding van wortelhals- en stengelaantasting door Leptosphaeria magulans (Phoma lingam).

Een behandeling tegen wortelhalsaantasting uitvoeren bij beginaantasting in het 4 blad- tot en met het 8 bladstadium (BBCH 14-18) en een behandeling tegen stengelaantasting in het voorjaar (BBCH 35-55) uitvoeren. Maximaal 2 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.


 

Vlas, ter bestrijding van echte meeldauw (Oidium lini)

Een behandeling voor de bloei uitvoeren. Maximaal 1 bespuiting per seizoen uitvoeren.

Dosering: 0,4 liter middel per ha.

 

Appels en peren, ter bestrijding van schurft (Venturia inaequalis en V. pirina).

Het middel dient curatief te worden toegepast tot maximaal 96 uur na het tot stand komen van een schurftinfectie.

De preventieve werkingsduur van Score 250 EC bedraagt maximaal 2 dagen.

De bespuitingen zonodig herhalen bij het optreden van nieuwe infecties. Maximaal 4 bespuitingen per seizoen uitvoeren.

Dosering: 0,015 % (15 ml middel per 100 liter water)

 

Bloemkool, broccoli en Chinese broccoli, ter bestrijding van bladvlekkenziekten (Mycosphaerella brassicicola en Alternaria spp.)

Een behandeling uitvoeren zodra een eerste aantasting wordt waargenomen. Een eventuele volgende behandeling na 2 tot 3 weken uitvoeren. Maximaal 2 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.

 

Sluitkool (rode kool, savooien kool, spitskool en witte kool), ter bestrijding van bladvlekkenziekten (Mycosphaerella brassicicola en Alternaria spp.)

Een behandeling uitvoeren zodra een eerste aantasting wordt waargenomen. Eventuele volgende behandelingen met een interval van 2 tot 3 weken. Maximaal 3 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.

 

Spruitkool, ter bestrijding van bladvlekkenziekten (Mycosphaerella brassicicola en Alternaria spp.)

Een behandeling uitvoeren zodra een eerste aantasting wordt waargenomen. Eventuele volgende behandelingen met een interval van 2 tot 3 weken. Maximaal 3 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.

 

Boerenkool, Chinese kool en Oosterse bladkolen (zoals amsoi en paksoi), ter bestrijding van bladvlekkenziekten (Mycosphaerella brassicicola en Alternaria spp.)

Een behandeling uitvoeren zodra een eerste aantasting wordt waargenomen. Een eventuele volgende behandeling na 2 tot 3 weken uitvoeren. Maximaal 3 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.

 

Rode biet, ter bestrijding van bladvlekkenziekte (Cercospora beticola).

Een behandeling uitvoeren zodra aantasting wordt waargenomen. Indien nodig kan de toepassing na 2 tot 3 weken worden herhaald. Maximaal 2 bespuitingen per seizoen uitvoeren.

Dosering: 0,4 liter middel per ha.

Een behandeling tegen bladvlekkenziekte heeft ook een werking tegen Ramularia beticola,  roest (Uromyces betae) en meeldauw (Erysiphe betae)

 

Knolselderij en bleekselderij, ter bestrijding van bladvlekkenziekte (Septoria apiicola)

Een behandeling uitvoeren zodra aantasting wordt waargenomen. Eventuele volgende behandelingen met een interval van 2 weken. Maximaal 3 bespuitingen per seizoen uitvoeren.

Dosering: 0,4 liter middel per ha.

 

Snijselderij en peterselie, ter bestrijding van bladvlekkenziekte (Septoria apiicola)

Een behandeling uitvoeren zodra aantasting wordt waargenomen. Een eventuele volgende behandeling na 2 weken uitvoeren. Maximaal 2 bespuitingen per seizoen uitvoeren.

Dosering: 0,4 liter middel per ha.

 

Bospeen, waspeen, winterwortel en pastinaak ter bestrijding van loofverbruining (Alternaria dauci)

Een behandeling uitvoeren zodra een eerste aantasting wordt waargenomen. Eventuele volgende behandelingen met een interval van 2 weken. Maximaal 3 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.

 

Asperges, ter bestrijding van stengelsterfte (Stemphylium spp.) en grauwe schimmel (Botryotinia fuckeliana=Botrytis cinerea)

Een behandeling uitvoeren vanaf begin augustus tot en met september met een interval van circa 2 weken. Maximaal 3 bespuitingen per seizoen uitvoeren.

Dosering: 0,5 liter middel per ha.

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 5 februari 2010 tot vereenvoudigde uitbreiding van de toelating van het middel Score 250 EC, toelatingnummer 11453 N

 

RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        3

 

2.   Physical and chemical properties                  3

 

3.   Methods of analysis                                         3

 

4.   Mammalian toxicology                                      5

 

5.   Residues                                                            10

 

6.   Environmental fate and behaviour                18

 

7.   Ecotoxicology                                                    50

 

8.   Efficacy                                                               83

 

9.   Conclusion                                                        83

 

10. Classification and labelling                             83


1.         Identity of the plant protection product

 

1.1       Applicant

Stichting Trustee Bijzondere Toelatingen

Hogeweg 16

2585 JD  'S-GRAVENHAGE

 

1.2       Identity of the active substance

Common name

Difenoconazole

Name in Dutch

difenoconazool

Chemical name

3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether

CAS no

119446-68-3

EC no

Not allocated

 

1.3       Identity of the plant protection product

Name

Score 250 EC

Formulation type

EC

Content active substance

250 g/L

 

1.4       Function

Fungicide.

 

1.5       Uses applied for

See GAP appendix 1.

 

1.6       Background to the application

It concerns a simplyfied third party extension of the authorization.

 

1.7       Packaging details

Packaging details do not change.

 

 

2.                 Physical and chemical properties

 

The physical and chemical properties of the plant protection product remain unchanged.

 

 

3.                 Methods of analysis

 

3.1       Residue analytical methods

 

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

HPLC-MS/MS; LOQ = 0.02 – 0.05 mg/kg

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)

Difenoconazole and CGA 205375: HPLC-MS/MS; LOQ  = 0.01 mg/kg

 


Based on the proposed use of the plant production product, the analytical methods for determination of residues in food/feed of plant origin are required to be validated for watery (beetroot, chinese broccoli, kale, chinese cabbage, eastern marrow-stem cabbage, swede, turnip and parsnip) and fat matrix (linseed)

 

Definition of the residue and proposed MRL’s for difenoconazole

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

Difenoconazole

See residues section

Food/feed of animal origin

Difenoconazole + CGA 205375

See residues section

 

The residue analytical methods, included in the abovementioned table, are suitable for monitoring of the proposed MRL’s.

 

The residue analytical methods for air, soil and water were accepted during the assessment which led to the original authorization of Score 250 EC. This simplified third party extension does not give rise to re-assess these residue analytical methods.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRL’s.

 

3.2       Data requirements

None.

 

3.3       Physical-chemical classification and labelling

The current classification and labelling can be maintained

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

 

Regarding the physical and chemical properties of the formulation, the method of application and the further information on the plant protection product, the following labelling of the preparation is proposed (classification and labelling does not change):

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

 

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:

-

Indication of danger:

-

R phrases

-

-

S phrases

21

When using do not smoke

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

-

Tactile warning of danger obligatory?

-

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

Supported shelf life of the formulation: 2 years

 

 

4.                 Mammalian toxicology

 

List of Endpoints

Difenoconazole is an existing active substance. It is a ‘green track’ substance and as such included in Annex I of 91/414/EEC since 1 January 2009. The member states commented on the DAR, but the further peer review will be performed at a later stage. The List of Endpoints presented below is therefore taken from the DAR (List of Endpoints of December 2006). Where relevant, some additional remarks/information are given in italics.

 



Absorption, distribution, excretion and metabolism (toxicokinetics) (Annex IIA, point 5.1)

Rate and extent of oral absorption

About 80 - 90% based on the biliary (73- 76%), urinary (14 -9%) excretion observed in bile duct cannulated rats within 48 hours. Lower absorption rates at higher dose levels.

Distribution

Initially highest residues in fat, liver, brown fat, Harderian gland, adrenal gland and stomach.  At 168 hours, residues above the plasma concentration only detected in fat.

Potential for accumulation

No evidence for accumulation

Rate and extent of excretion

Rapid and extensive (> 92%) within 48 hours mainly via faeces (>77%) and in urine (>12%). Entero hepatic recirculation demonstrated.

Metabolism in animals

Extensively metabolised, approximately 68% of the dose recovered in faeces as metabolites hydroxyl-CGA-205375, hydroxyl-CGA-169374 and CGA-205375. 1, 2, 4- triazole determined to represent <10% in male rats.

Toxicologically relevant compounds
(animals and plants)

Pending: genotoxicity studies of plant metabolites 1, 2, 4-triazole (CGA 131013) and triazole lactic acid (CGA 205369) are in progress. 1

Toxicologically relevant compounds
(environment)

None

1 There are several substances which form triazole metabolites after application. The toxicity of the different triazole metabolites has been discussed in PRAPeR expert meeting 9 (Jan. 2007). The meeting considered the metabolites 1,2,4-triazole, triazole-alanin and triazole acetic acid as toxicologically relevant.

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

1453 mg kg-1 

R22

Rat LD50 dermal

>2010 mg kg-1 

 

Rat LC50 inhalation

>3300 mg/m3

 

Skin irritation

Non-irritant

 

Eye irritation

Non- irritant

 

Skin sensitisation

Non-sensitiser

 

 

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Rat: liver/Reduced body weight, heart and carcass weight. Reduced food and water consumption.

Dog: cataract formation

Relevant oral NOAEL

90-day toxicity (rat): 20/21 (M/F) mg kg-1 day-1

28 week (dog): 31/35 mg kg-1 day-1

 

Relevant dermal NOAEL

28-day toxicity (rat): 1 000 mg kg-1 day-1

 

Relevant inhalation NOAEL

N/E

N/R

 

Genotoxicity (Annex IIA, point 5.4)

 

Substance is unlikely to be genotoxic.

Increases in chromosomal aberrations were reported in CHO cells treated in vitro with difenoconazole, but only at high concentrations inducing cytotoxicity and they were not clearly reproducible either between repeat examinations of the same slides, between experiments or across studies. 2

 

2 In vitro, difenoconazole was negative in both bacterial and mammalian cell assays for gene mutation, negative

for chromosomal damage in cytogenetic assays using isolated human lymphocytes and negative for DNA

damage/repair in the unscheduled DNA synthesis assay. In vivo, difenoconazole was negative for chromosomal

damage in the mouse bone marrow micronucleus assay. It is concluded that difenoconazole is not genotoxic.

 

Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect

Rat: reduced body weight gain and reduced absolute body weight

Mouse: liver/reduced body weight gain

Relevant NOAEL

2-year combined chronic toxicity/oncogenicity in rat:

1.0/1.3 (M/F) mg kg-1 day-1

18 months oncogenicity study in mice:

4.7/ 5.6 (M/F) mg kg-1 day-1

Carcinogenicity

In view of the lack of genotoxicity and the finding of liver adenomas/carcinomas only in mice and only at concentrations at which toxicity was observed, the substance is considered not likely to pose a carcinogenic risk to humans.

 

 

Reproductive toxicity (Annex IIA, point 5.6)

Reproduction toxicity

Reproduction target / critical effect

Retarded body weight gain, reduced absolute pup body weights

 

Relevant parental NOAEL

250 ppm @ 17.3 mg kg-1 day-1

 

Relevant reproductive NOAEL

>2500 ppm @ 178.0 mg kg-1 day-1 for the reproductive parameters analysed.

 

Relevant offspring NOAEL

250 ppm @ 17.3 mg kg-1 day-1

 

 

Developmental toxicity

Developmental target / critical effect

Reduced body weight gain/reduced food consumption (rat, rabbit)

 

Relevant maternal NOAEL

25 mg kg-1 day-1

 

Relevant developmental NOAEL

25 mg kg-1 day-1

 

 

Neurotoxicity (Annex IIA, point 5.7)

Acute neurotoxicity

No data available

N/R

Repeated neurotoxicity

No data available

N/R

Delayed neurotoxicity

No data available

N/R

 

Other toxicological studies (Annex IIA, point 5.8)

Mechanism studies

Supplementary study on enzyme induction performed concluding that difenoconazole is a reversible barbiturate-type inducer of metabolising enzymes in the mouse liver.

Studies performed on metabolites or impurities

 

The major metabolites found in the mammalian metabolism of difenoconazole (CGA 205374, CGA 205375 and CGA 189138) were further investigated regarding the acute oral toxicity and the ability to induce mutations in bacteria. The results raise no concern.

Relevant studies on plant metabolites, including studies of toxicokinetics, acute oral toxicity and genotoxicity, were submitted for triazole alanine (CGA 131013) and triazole acetic acid (CGA 205369). The results raise no concern. Genotoxicity studies of 1, 2, 4-triazole and triazole lactic acid are in progress and RMS suggests to include these in an addendum to the DAR.

 

Medical data (Annex IIA, point 5.9)

 

No detrimental effects on health in manufacturing personnel.

 

Summary (Annex IIA, point 5.10)

Value

Study

Safety factor

ADI

0.01 mg kg-1 day-1

2-year combined chronic toxicity/

oncogenicity in rat

100

AOEL

0.20 mg kg-1 day-1

90-day rat

100

ARfD

0.20 mg kg-1 day-1

90-day rat

100

 

Dermal absorption (Annex IIIA, point 7.3)

Formulation (SCORE® 250 EC (A 7402 G, EC)

 (23.2% w/w)

1.4% undiluted solution, 4.6% diluted spray solution.

Rat in vivo and comparative in vitro human/rat skin. 3

3 NL commented on the DAR with regard to the evaluation of the in vivo and the in vitro study and proposed different values for dermal absorption of 3%, 1% and 0.24% for the low, mid and high dose, respectively. See 4.2 for more details.

 

Local effects

Difenoconazole does not produce local effects, neither after a single nor repeated exposure.

 

Data requirements active substance

No additional data requirements are identified.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

No new data was submitted regarding the toxicity of the formulated product. Acute toxicity studies with Score 250 EC were also summarised and evaluated in the DAR on difenoconazole.

The formulation Score 250 EC does not need to be classified on the basis of its acute oral (LD50 rat 3129 mg/kg bw), dermal (LD50 rat >5000 mg/kg bw), and inhalation toxicology (LC50 rat >5.17 mg/L).

The formulation Score 250 EC is not classifiable as a skin or eye irritant.

The formulation Score 250 EC does not have sensitising properties in a Buehler test. Although the Buehler test is the least preferable to test for skin sensitisation, the study is considered acceptable as Score 250 EC does not contain any formulants with skin sensitising properties.

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 


4.2       Dermal absorption (IIIA 7.3)

Two dermal absorption studies are available in the DAR: an in vivo study in rats and an in vitro study with rat and human skin membranes, both performed with difenoconazole formulated as Score 250 EC. The results of the in vivo study show a dermal absorption of 30, 12, and 8% for an area dose of 0.5 µg/cm2, 12.5 µg/cm2 and 2500 µg/cm2, respectively. From the in vitro study, flux ratios (human/rat skin) of 0.1, 0.08, and 0.03 were derived. For the risk assessment this results in 0.3% for the concentrate (2.5 mg/cm2) and 3% for the spray dilution (0.5 µg/cm2) (these are rounded values because of the wide variation in the study results). These area doses are also relevant for the current risk assessment.

In conclusion, for the current risk assessment a dermal absorption value of 0.3% for the concentrate and 3% for the spray dilution will be used.

 

4.3       Available toxicological data relating to non-active substances (IIIA 7.4)

None of the other formulants raise concerns that have not been addressed in the submitted studies.

 

4.4       Exposure/risk assessments

The intended uses are listed in the GAP (appendix 1).

 

4.4.1    Operator exposure/risk

According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:

Tier 1: Risk assessment using the EU-AOEL without the use of PPE

Tier 2: Risk assessment using the NL-AOEL without the use of PPE

Tier 3: Refinement of the risk assessment using new dermal absorption data

Tier 4: Prescription of PPE

 

Tier 1

 

Calculation of the EU-AOEL / Tolerable Limit Value (TLV)

For difenoconazole no TLV has been set. The AOEL will be used for the risk assessment.

The formulation is applied 1-3 times during a period of 6 months with a spray interval of minimally 14 days; a chronic exposure duration would be applicable. However, since the number of applications is limited to maximally 3 within these 6 months and the rate and extent of excretion is rapid and extensive (> 92% within 48 hours), it is concluded that the active substance is no longer present in the body after the spray interval of 14 days. Hence, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived.

Since difenoconazole is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.20 mg/kg bw/day (= 14 mg/day for a 70-kg operator), based on the 90-day study in rats is used for the risk assessment (see List of Endpoints).

 

Exposure to difenoconazole during mixing and loading and application of Score 250 EC is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.


 

Table T.1 Internal operator exposure to difenoconazole and risk assessment for the use of Score 250 EC

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on Chinese broccoli, leafy brassica’s, kale, swedes, turnips, parsnips, flax and beetroot

Mixing/

Loading

Respiratory

0.01

14

<0.01

Dermal

0.08

14

0.01

Application

Respiratory

0.01

14

<0.01

Dermal

0.11

14

0.01

 

Total

0.20

14

0.01

a       External exposure was estimated by  EUROPOEM. Internal exposure was calculated with:

·       biological availability via the dermal route:   0.3% and 3% for concentrate and dilution, resp. (see 4.2)

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

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

 

Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.

 

4.4.2    Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

 

4.4.3    Worker exposure/risk

Shortly after application on flax it is not necessary to perform any re-entry activities during which intensive contact with the treated crop will occur. Therefore no worker exposure is calculated.

 

Shortly after application on i.a. Chinese broccoli, swedes, turnips it is possible to perform re-entry activities during which intensive contact with the treated crop will occur, e.g. as these crops may be harvested manually. Therefore, worker exposure is calculated.

 

Tier 1

The exposure is estimated for the unprotected worker. In Table T. 2 the estimated internal exposure is compared with the systemic EU-AOEL.

 

Table T.2  Internal worker exposure to difenoconazole and risk assessment after application of Score 250 EC

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Re-entry activities i.a. Chinese broccoli, swedes, turnips

 

Respiratory

-

14

-

Dermal

0.17

14

0.03

 

Total

0.17

14

0.03

a       External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:

·       biological availability via the dermal route:  3% (see 4.2)

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

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

-        No model available

 

Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

 

Operator exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to difenoconazole as a result of the application of Score 250 EC in the cultivation of Chinese broccoli, leafy brassica’s, kale, swedes, turnips, parsnips, flax and beetroot.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to difenoconazole during application of Score 250 EC in the cultivation of Chinese broccoli, leafy brassica’s, kale, swedes, turnips, parsnips, flax and beetroot.

 

Worker exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in the cultivation of Chinese broccoli, leafy brassica’s, kale, swedes, turnips, parsnips, flax and beetroot due to exposure to difenoconazole after application of Score 250 EC.

 

4.5       Appropriate mammalian toxicology and operator exposure endpoints relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

No data requirements were identified

 

4.7       Combination toxicology

Score 250 EC contains only one active substance and it is not described that it should be used in combination with other formulations.

 

4.8       Mammalian toxicology classification and labelling

The current classification and labelling (no classification and labelling for toxicology), which is prepared in conformity with Directive 1999/45/EC, can be maintained.

 

 

5.                 Residues

 

Difenoconazole is an existing active substance. It is a ‘green track’ substance and as such included in Annex I of 91/414/EEC since 1 January 2009. The member states commented on the DAR, but the further peer review will be performed at a later stage. The List of Endpoints presented below is therefore taken from the DAR (List of Endpoints of December 2006). Where relevant, some additional remarks/information are given in italics.


 

List of Endpoints

 

Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)

Plant groups covered

- Cereals, seed treatment (BBCH 00).

- Root vegetables (carrot), foliar treatment (BBCH 42/43)

- Fruits (pome fruit), foliar treatment (BBCH 61)1

Rotational crops

Leafy vegetables (lettuce, spinach), root vegetables (carrot, sugarbeet, turnip), cereals (spring and winter wheat, maize), oilseeds (mustard)

Metabolism in rotational crops similar to metabolism in primary crops

Yes, in part. Two metabolites were observerd: triazole alanine (CGA-131013) and triazole acetic acid (CGA-142856). No residues of parent difenoconazole were found. A  new metabolite was observed,

CGA-205369 (triazole lactic acid).

Processed commodities

Difenoconazole is stable under conditions representative of pasteurisation, baking/brewing/boiling and sterilisation (95.6 to 98.6% of the applied radioactivity consisted of parent difenoconazole).

Residue pattern in processed commodities similar to residue pattern in raw commodities

Yes, in part. Unprocessed apple = 0.023 mg/kga

Raw juice = <0.02 mg/kga (TF=<0.9)

Wet pomace = 0.1 mg/kga (TF=4.5)

amean value of 3 studies.

Plant residue definition for monitoring

Parent Difenoconazole

Plant residue definition for risk assessment

Parent Difenoconazole

Conversion factor (monitoring to risk assessment)

None

1nationally, in RIVM/CSR report 08653A00 (2002), metabolism studies in potato, rape, tomato, apple cell cultures, wheat and grapes were summarised. It was concluded that the metabolism of difenoconazole in these commodities were largely comparable.

 

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

Ruminant (goat), poultry (hen)

Time needed to reach plateau concentration in milk and eggs

48 hours in milk: [phenyl-14C] difenoconazole

144 hours in milk: [triazole-14C] difenoconazole

168 hours in egg yolk: [phenyl-14C] and [triazole-14C]

120 hours in eggs white: [triazole-14C] difenoconazole

Animal residue definition for monitoring

Parent difenoconazole + metabolite CGA-205375 (1-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-[1,2,4]triazol-1-yl-ethanol)

Animal residue definition for risk assessment

Parent Difenoconazole

Conversion factor (monitoring to risk assessment)

 

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

Yes

 

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

 

 

Maximum residues of difenoconazole in human food commodities of succeeding crops (lettuce, carrot, spinach) grown in rotation after cereals and carrots are not expected to exceed 0.01 mg/kg.

In one of four available studies, conducted with [triazole-14C] difenoconazole, high residues of difenoconazole equivalents/kg were found in mature maize and mature wheat grain (0.211 and 0.341 mg difenoconazole equivalents/kg, respectively). The majority of the TRR consisted of the metabolite CGA-131013 (triazole alanine; 44-66.2% TRR), CGA-142856 (triazole acetic acid; 25.9% TRR) and CGA-205369 (triazole lactic acid; 9.7%TRR) (see Table B.7.9.2-2, section B.7)

 

 

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

 

 

Potato, tomato, cotton (cottonseed oil), wheat (straw, forage and grain): stable at <‑20°C for at least 24 months.

Lettuce (head), soybean (beans), wheat forage, banana: stable at <‑20°C for at least 12 months.

Animal commodities (eggs, milk, beef liver, poultry breast):  stable at <‑20°C for at least 12 months.

 

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock ³ 0.1 mg/kg diet/day:

Ruminant:

Yesa

Poultry:

Nob

Pig:

           no

Metabolism studies indicate potential level of residues ≥ 0.01 mg/kg in edible tissues (yes/no)

 

 

 

 

Residue levels in feeding studies (dose level: mg/kg)

Mean (max) mg/kg

Muscle

*

N/R

N/R

Liver

*

N/R

N/R

Kidney

*

N/R

N/R

Fat

*

N/R

N/R

Milk

*

N/R

N/R

Eggs

*

N/R

N/R

*Dietary burden based on representative crops was not carried out, as this is not representative of the true dietary burden based on all registered crops. Calculation of the actual dietary burden and proposals for MRLs in products of animal origin will be included in the EU MRL submission.

aA new feeding study has recently been conducted. The samples have been analysed for parent difenoconazole and the metabolite CGA-205375 using updated analytical methods. Additionally, the level of 1, 2, 4-triazole in the samples has also been determined. The estimated completion of the final report for the study is mid-2006. The RMS suggests that this study could be included in an Addendum.

bThe transfer of residues of difenoconazole from poultry into tissues and eggs has been investigated in a new study. The level of 1, 2, 4-triazole in the tissues and eggs after feeding of difenoconazole has also being determined. The samples have been analysed and the final report is currently being written. The estimated completion of the final report for the study is mid-2006. The RMS suggests that this study could be included in an Addendum.

N/R=Not required

 

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Crop/processed crop

Number of studies

Transfer factor

% Transference *

Apple – washed fruit 

1

0.71

 

Apple – wet pomace

1

3.5

 

Apple – dry pomace

1

15.6

 

Apple – juice (before/after pasteurisation)

1

0.02/0.02

 

Apple - puree

1

0.14

 

Apple – wet pomace

3

6.5

 

Apple – juice (before pasteurisation)

3

<0.9

 

 

Comments on/additions to List of Endpoints

There are no comments or additions.

 

5.1       Summary of residue data

The following assessment is based on draft report 12132A01 (RIVM, 23 April 2009), report CTB-2007-003-RES (TNO, March 2007) and conclusions from RIVM report 09306A00 (12 September 2002).

Only points that are not covered by the List of Endpoints or that need clarification are discussed below.

 

5.1.1    Metabolism in plants

No difference was observed in the metabolism of the three crop groups studied, i.e. cereals, root vegetables and fruit (see List of Endpoints). Nationally, metabolism studies after foliar application in potato, rape, tomato, apple cell cultures, wheat and grapes were summarised. It was concluded that the metabolism of difenoconazole in these commodities were largely comparable. Therefore, no differences among all five crop groups are expected in the metabolism of difenoconazole. The available studies cover the crops in the intended use.

 

5.1.5    Supervised residue trials

A number of supervised residue trials have been submitted. Some were already summarised and evaluated by Germany for establishing of tMRLs for Annex III of Regulation (EC) 396/2005 (report 20070419_DE_difenoconazole-tMRLs.doc). This document is available on the Circa-website. All studies that had not yet been summarised, were summarised and evaluated in draft-RIVM report 12132A00.

 

Flax (linseed)

As the intended use on flax is equal to the intended use on oilseed rape in spring (except for dose rate 0.1 kg as/ha vs 0.125 kg as/ha, respectively), the results obtained in supervised residue trials in oilseed rape, can be extrapolated to flax.

Several reports containing supervised residue trials in spring and winter rape have been submitted. Some are available in the summary by Germany and the other were summarised in report 12132A00. The cGAP-NL (2x 0.125 kg as/ha, 1st application BBCH 14-18, 2nd application BBCH 35-55, PHI n.a. due to application depending on growth stage) is equal to the cGAP-NEU. Seven trials performed in N-EU are available. These trials were not performed in accordance with cGAP with regard to the growth stages at time of application1st: BBCH >18 and 2nd: BBCH > 63), but as this results in a worst-case and as residues were all below LOQ of 0.02 mg/kg, the trials are considered acceptable for performing a risk assessment. Although oil seed rape is a major crop, the seven available trials are considered sufficient as a “zero-residue situation” was demonstrated.

Residue levels  in combination with STMR and HR are presented in tabular form in table R1.

 

Beet roots

As the intended use on beet roots (cGAP 2x 0.1 kg as/ha, int 14d, PHI 28d) is equal to the intended use on sugar beets, the results obtained in supervised residue trials in sugar beet, can be extrapolated to beet roots.

Applicant submitted five supervised residue trials in sugar beet. The trials were performed with a too long interval in days, but the spray interval was in accordance with the growth stages prescribed in the intended use.

All trials are therefore considered acceptable.

 

Twenty supervised residue trials have been previously evaluated. In two trials, samples were taken only at PHI 40 or 47 days; in one trial, only one application of 0.125 kg as/ha was made; in four trials 3 applications of 0.1 kg as/ha or 4x 0.125 kg as/ha were made. Results from these seven trials will not be used.

Six trials were performed with intervals that were too long (32-36 days) or too short (11-14 days). As the residue levels in these studies are of the same order of magnitude as the results in the correctly performed studies, the results from these six trials are used in this assessment.

 

In total, eighteen trials were considered acceptable for risk assessment. In several trials, higher residue levels were detected at sampling times later than PHI=28 days, in these cases, the residue levels at later time points were used and are marked with #.

Residue levels  in combination with STMR and HR are presented in tabular form in table R1.

 

Chinese broccoli

As the intended use on broccoli and cauliflower is equal to the intended use on Chinese broccoli, the results obtained in supervised residue trials in broccoli and cauliflower, can be extrapolated to the whole group of flowering brassica’s, including Chinese broccoli.

Seven supervised residue trials in flowering brassica’s were submitted; three in cauliflower, four in broccoli. The trials were not performed in accordance with cGAP-NL (2x 0.125 kg as/ha, int 14d., PHI 14d), but with cGAP-EU (3x 0.125 kg as/ha, int 7d, PHI 14d) and are therefore considered to be acceptable.

 

The results of the trials in broccoli were not used as modification of GC-NPD method AG-575A, used for the determination of difenoconazole in broccoli is considered insufficiently validated, because:

-        the requirement for a reduced validation is not met for broccoli (2 spike levels, each n=3) and therefore no precision data are available.

-        no information is available on the linearity of response.

 

In the summary by Germany, eleven supervised residue trials in cauliflower and one trial in broccoli were summarized. Three trials in cauliflower and one trial in broccoli are considered to be acceptable, as they were performed with 2-3x 0.1-0.125 kg as/ha, int 14d, PHI 14d. The other trials were performed with too long intervals.

 

The data set is not fully in accordance with guidance document SANCO 7525/VI/95, rev 8, which states that Residue trials started/planned at the beginning of 1 January 2003 at the latest should comply with this extrapolation. Up to this date the extrapolation cauliflower ↔ broccoli is accepted.

The three new trials were performed in 2005, the trials in the summary by Germany in 1999 and 2001. As the trials were performed both before and after January 1st, 2003, the dataset is considered to be complete, even though there should be eight trials available, and can be used for risk assessment as the temporary EU-MRL is based on trials in the summary by Germany.

Residue levels in combination with STMR and HR are presented in tabular form in table R1.

 

Kale

Four trials have been submitted and were summarised in Ctgb report 20080302-sava-res (February 2009). For EU-MRL setting, a different cGAP was initially notified (3x 0.1 kg a.s./ha, int 10d, PHI 14d).  The new cGAP-EU is 2x 0.2 kg a.s./ha, int 14d and PHI 14d and is equal to the cGAP-NL. In the summary by Germany, four trials were summarized which are in accordance with the former EU-cGAP; these will therefore notbe used in this assessment. The four newly submitted trials were performed according to cGAP-NL. The residue levels are presented in table R1.

 

Leafy brassica’s (Chinese cabbage, pak-choi cabbage, mustard cabbage a.o.)

As the intended use on other leafy brassica’s is equal to the intended use on kale, the results obtained in supervised residue trials in kale, can be extrapolated to other leafy brassica’s.

 

Parsnip, swedes and turnips

Results obtained in supervised residue trials in carrots, can be extrapolated to parsnip, swedes and turnips, as the cGAP is the same for these crops (3x 0.12 kg as/ha, int 14d, PHI 14d).

 

Six supervised residue trials in carrots were submitted. Five trials were performed in accordance with cGAP; in one trial sample were only taken at PHI 7d, the result form this trial will not be used.

In a previous assessment for an application for extension of the label of Score 250 EC, twelve other supervised residue in carrots were evaluated in RIVM report 09306A00 (November 2003). Of these trials seven were performed in accordance with cGAP and five were considered acceptable.

The residue levels selected for MRL setting and risk assessment are presented in table R1.

 

Table R1: Selected residue levels from trials with difenoconazole

Crop

Extrapolation to

Residue levels selected for MRL setting (mg/kg)

STMR

(mg/kg)

HR

(mg/kg)

Oilseed rape, winter and summer

Flax/linseed

<0.02 (7x)

<0.02

<0.02

Sugar beet

Beet root

0.01, <0.02 (7x), 0.02, 0.02#, 0.033, 0.06 (3x), 0.08 (2x), 0.10 (2x)

<0.02

0.1

Cauliflower and broccoli

Chinese broccoli

<0.01, <0.02 (4x), 0.03, 0.05, 0.08

<0.02

0.08

Kale

Leafy brassica’s (Chinese cabbage, a.o.)

0.19, 0.43, 0.74, 0.92

1.04

3.3

Carrot

Parsnip, swedes and turnips

0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.13, 0.22, 0.28

0.07

0.28

 


 

5.1.7    Residues from livestock feeding studies

Feeding studies in dairy cows and laying hens were submitted for a previous application for extension of authorisation of Score 250 EC. These studies were summarised and evaluated in report 12139A01 (RIVM, 4 June 2009).

 

Dairy cows

In a feeding study, cows were dosed difenoconazole at levels of 0, 1, 5, and 15 mg ai/kg feed during 29-30 days. These dose rates are comparable to approximately 0, 0.2, 1 and 3N.

Residues of difenoconazole (<0.01 mg/kg for tissues, <0.005 mg/kg for milk) did not accumulate in milk or tissue samples even following dosing at the exaggerated levels. Only in liver low residue levels were found at a level up to 0.03 mg/kg at the highest dose level.

At the 1 mg/kg dose level, residues of CGA205375 were less than the limit of quantification in muscle (<0.01 mg/kg) and milk (<0.005 mg/kg).  In the remaining tissues, residues ranged from 0.05 to 0.07 mg/kg in liver, <0.01 to 0.02 mg/kg in fat and <0.01 to 0.01 in kidney.  Residues of CGA205375 in all matrices in the 5 and 15 mg/kg feeding levels were generally proportional to the dose.

Residues of CGA71019 were below the limit of quantification in milk and all tissue samples at the 1 mg/kg dose level. Fat did not contain any CGA71019 at any dose level. For milk, kidney and muscle, residues ranged from 0.01 up to 0.03 mg/kg at the 5 mg/kg dose level and from <0.03 up to 0.05 mg/kg at the 15 mg/kg dose level. Residue levels in liver ranged from <0.01 – 0.01 at the 5 mg/kg dose level to 0.02 – 0.03 at the highest dose level.

 

Laying hens

In a feeding study in hens, the hens were dosed difenocozole at levels of 0, 0.3, 1, 3 and 10 mg/kg feed. These dose rates are comparable to 0, 0.3, 1.2, 3 and 12N. Residues of difenoconazole (all <0.01 mg/kg) did not accumulate in eggs or tissue samples even following dosing at the exaggerated levels. 

Residues of CGA205375 were less than the limit of quantification in all tissues.  Residues were detected for the first time in eggs after 3 or 6 days at the higher dose levels.  The average residues in eggs from 6 to 28 days were 0.01, 0.04, and 0.13 mg/kg at the 1, 3 and 10 mg/kg dose levels, respectively.

Residues of CGA71019 were at or below the limit of quantification in the tissue samples except at the 10 mg/kg dose level where residues were found in muscle, liver and skin with attached fat. 

The average residues in eggs after 3 days in the 1, 3 and 10 mg/kg dose levels were 0.005, 0.015 and 0.046 mg/kg, respectively. Whereas the average residues in eggs from 6 to 28 days in the 1, 3 and 10 mg/kg dose levels were 0.007, 0.020 and 0.060 mg/kg, respectively.

 

5.1.8    Processing factors

Processing studies were submitted for carrots. Processing factors are summarized in the table. For processing studies, where RSD < 40%, the median processing factor was considered the best estimate. For processing studies, where RSD>40%, the maximum processing factor was considered to be the best estimate.


 

Table R2: Overview of processing factors

Crop

Processed product

Number

of studies

P-factors found

Proposed P-factor

for dietary calculations

carrot

cooked carrots

4

0.040, 0.045, 0.045, 0.065,

mean 0.049, RSD 23%

0.045 (median)

 

canned carrots

4

0.023, 0.032, 0.045, 0.12,

mean 0.055, RSD 80%

0.12 (maximum)

 

carrot juice

4

0.023, 0.045, 0.065, 0.12,

mean 0.063, RSD 67%

0.12 (maximum)

 

5.1.9    Calculation of the ADI and the ARfD

Calculation of the ADI

The ADI is based on the NOAEL of 1.0 mg/kg bw/d in the 2-year combined chronic toxicity/

oncogenicity in rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.01 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

Calculation of the ARfD

The ARfD is based on the NOAEL of 20 mg/kg bw/d in the 90-day oral rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD of 0.20 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

5.2       Maximum Residue Levels

Temporary EU-MRLs are present in Annex IIIa of Regulation (EC) 396/2005. Applications to modify the existing MRLs for parsley, chervil and fennel have been submitted to EFSA by Belgium and are pending.

The temporary EU-MRLs for linseed, beet root, parsnips, Chinese broccoli and leafy brassica’s cover the intended use for these crops. The intended use for swedes and turnips, however, is not covered by the intended use. The tEU-MRL is 0.1 mg/kg, whilst the MRL calculation results in Rber: 0.33 mg/kg and Rmax: 0.26 mg/kg. An MRL of 0.3 mg/kg is in order and needs to be notified.

The product complies with the MRL Directives/Regulation for linseed, beet root, parsnips, Chinese broccoli and leafy brassica’s, but not for swedes and turnips.

Notification of revised MRLs is necessary for swedes and turnips.

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev. 2.0, containing all available Member State diets, and the proposed EU-MRLs for parsley, chervil and fennel and temporary EU-MRLs. The maximum TMDI is 96.9% of the ADI for WHO Cluster Diet B. The TMDI is 36.8% and 72% of the ADI for the Dutch general population and Dutch children ages 1-6, respectively.

 

Risk assessment for acute exposure through diet

A calculation of the Estimated Short Term Intake (ESTI) was carried out using EFSA PRIMo rev. 2.0 and the temporary EU-MRLs and accompanying HRs for the crops applied for. The highest percentage of the ESTI is 17.1 % of the ARfD for Chinese cabbage for the Dutch children. ESTI values for the other commodities in all other consumer diets are all lower.


 

Conclusion

The product complies with the Uniform Principles. The product does not comply with Regulation (EC) 396/2005 regarding the MRLs for swedes and turnips.

 

5.4       Data requirements

No actual data requirement, all data are present.

The claimed applications can be granted excepted for swedes and turnips. For swedes and turnips an harmonised EU-MRL is required. MRL application is done by Ctgb.

 

 

6.                 Environmental fate and behaviour

 

The Plant Protection Products and Biocides Regulations (RGB) published in the Government Gazette (Staatscourant) 188 of 28 September 2007 came into effect on 17 Oktober 2007, while repealing the Uniform Principles Decree on Plant Protection Products (BUBG) and the Regulation elaborating the uniform principles for plant protection products (RUUBG).

 

Risk assessment is done in accordance with Chapter 2 of the RGB for products based on
- active substances which have already been included in Annex I of directive 91/414/EEC

- “new” active substances;

or

Risk assessment is done in accordance with Chapter 10 of the RGB for products based on
- active substances which have not been included in Annex I of directive 91/414/EEC.

This means that for the current application of Score 250 EC, risk assessment is done in accordance with Chapter 2 of the RGB.

 

Difenoconazole is an existing active substance included in Annex I of Guideline 91/414/EEC since 1st January 2009 (directive 2008/69 d.d. 1st July 2008) via the green track procedure by SCFCAH. RMS was Sweden. Hence it is included without the full peer review for now. Therefore the Dutch comments to the DAR, sent to EFSA in May 2007, are added to the List of Endpoints in italics.

 

In The Netherlands four difenoconazole formulations are authorised, Score 250 EC (11453 N) and Score 10WG (12497 N), Budget difenoconazole 250 EC (12690 N) and Spyrale (12975 N).

 

The current risk assessment is based on the List of Endpoints d.d. December 2006 (taken from the final review report from March 14th of 2008). A remark in the final review report is that ‘Member States must pay particular attention to the protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate.’.

 

For a metabolite of difenoconazole, 1,2,4-triazole (CGA 71019), a separate List of Endpoints with regard to input parameters for groundwater modelling is available (from Circa, archive PRAPeR peer review, PRAPeR 12). These endpoints are added at the relevant sections of the List of Endpoints in italic.

NB For the difenoconazole dossier, it appears that the List of Endpoints with regard to the metabolite CGA 71019 was already almost identical to the agreed List of Endpoints for 1,2,4-triazole.

 

In RIVM report 11960 the MPCsoil-derivation of difenoconazole is described and referred to in the relevant section.

Furthermore, data submitted by the applicant, which are summarized and evaluated in RIVM report 11959 ( December 2008)/ EPP report 090401 (17-04-2009), are included in List of Endpoints and used in the risk assessment where relevant.

 

List of Endpoints                                                                                                                          

Rapporteur Member State

Month and year

Active Substance (Name)

Sweden

May 2006 Updated December 2006

Difenoconazole

 

Fate and behaviour in the environment

 

List of Endpoints Fate/behaviour 


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Mineralization after 100 days ‡

 

1.6-2.1% after 90/120 d [14C-triazole]-label (n=2)

3.7-19.3% after 90/100/120 d [14C-chlorophenyl]-label (n=6)

Non-extractable residues after 100 days ‡

 

21.8-36.6% after 90/120 d [14C-triazole]-label (n=2)

17.4-33.7% after 90/100/120 d [14C-chlorophenyl]-label (n=6)

Metabolites requiring further consideration ‡
- name and/or code, % of applied (range and maximum)

CGA 205375: max. 4.4-9.7% after 56-120 d

[14C-triazole] and [14C-chlorophenyl] labels (n=7)

CGA 71019: max. 20.6-23.4% after 190/271 d

[14C-triazole]-label (n=2)

 

 

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Anaerobic degradation ‡

Mineralization after 100 days

 

0.1% after 110 d [14C-triazole]-label (n=1)

 

Non-extractable residues after 100 days

 

11.6% after 110 d [14C-triazole]-label (n=1)

 

Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)

None

Soil photolysis ‡

Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)

None

 


 

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Laboratory studies ‡

Difenoconazole

Aerobic conditions

Soil type

g/ha[1]

pH

t. oC / % MWHC

DT50 /DT90 (d)

DT50 (d)3

20 °C pF2/10kPa

St.

(r2)

Method of calculation

loam

141

7.2

20 / 40

104 / 345

64

0.999

SFO

loam

143

7.2

20 / 40

118 / 392

72

0.998

SFO

sand

75

5.0

20 / 40

123 / 409

105

0.913

SFO

silt loam

750

7.2

20 / 60

4562 / >>2732

-

0.892

SFO

silt loam

750

7.2

30 / 60

1752 / >>1782

-

0.977

SFO

silt loam

750

7.2

20 / 30

7092 / >>2812

-

0.855

SFO

silt loam

750

7.2

20 / 60

3452 / >>2812

-

0.973

SFO

silt loam

750

7.2

10 / 60

6022 / >>2812

-

0.952

SFO

silt loam

75

7.2

20 / 60

83 / 277

58

0.950

SFO

loam

128

7.2

20 / 30

1362 / 4522

-

0.986

SFO

loam

128

7.2

10 / 60

3382 / >10002

-

0.993

SFO

loam

12.8

7.2

20 / 60

53 / 175

37

0.995

SFO

loam

sterile

128

7.2

20 / 60

>10002 / >10002

-

-

-

sandy loam

193

7.4

20 / 40

149 / 496

100

0.977

SFO

sandy loam/loamy sand

 

193

 

7.5

 

20 / 40

 

186 / 617

 

133

 

0.939

SFO

silty clay loam

193

6.7

20 / 40

187 / 620

107

0.972

SFO

Geometric mean

117 / 388

79

 

Median

120 / 400

86

 

1 Test concentration re-calculated into corresponding g a.s./ha dose for comparison with the representative uses. Rate of degradation of difenoconazole appeared to be decreased at high test concentrations. Results from studies carried out at test concentration corresponding to 750 g a.s./ha were therefore not included in the mean/median since this rate exceeds the maximum treatment rate recommended.

2 Values not included in the mean/median because they were obtained from high test concentrations or from 10/30ºC, dry moisture or sterile conditions.

3 In case the same soil was tested under standard conditions, the variations in temperature and moisture were not considered for mean/median values of normalised data.

 

 

CGA 71019

Aerobic conditions

Soil type

 

pH

t. oC / % MWHC

DT50/ DT90
(d)

f. f. kdp/kf

DT50 (d)

20 °C pF2/10kPa

St.

(r2)

Method of calculation

sandy loam

6.4

20 / 40

6.3 / 21

-

4.3

0.75

SFO

loamy sand

5.8

20 / 40

9.9 / 33

-

7.6

0.81

SFO

silt loam

6.7

20 / 40

12 / 41

-

7.5

0.95

SFO

Geometric mean

9.1 / 30.5

 

6.3

 

Median

9.9 / 33

 

7.5

 

 

Agreed endpoint for 1,2 4- triazole (PRAPeR 12)

1,2,4-triazole

Aerobic conditions

Soil type (USDA)

 

 

pH

(CaCl2)

t. oC / % MWHC

DT50/ DT90
(d)

 f. f.    kdp/kf

DT50 (d)

20°C pF2/10kPa

St.

(r2)

Method of calculation

Sandy loam

 

6.4

20oC / 40 % MWHC

6.32 / 21.0

 

5.0

0.75

SFO

Loamy sand

 

5.8

20oC / 40 % MWHC

9.91 / 33.0

 

9.9

0.81

SFO

Silt loam

 

6.7

20oC / 40 % MWHC

12.27 / 40.8

 

8.2

0.95

SFO

Geometric mean

 

 

 

7.4

 

 

 

Agreed End-point for calculating PEC soil for EU assessments 12 days (Not normalised).

 

CGA 205375

Aerobic conditions

Soil type

 

pH

t. oC / % MWHC

DT50/ DT90
(d)

f. f. kdp/kf

DT50 (d)

20 °C pF2/10kPa

St.

(r2)

Method of calculation

sandy loam

7.4

20 / 40

93 / 309

-

63

0.980

SFO

sandy loam/loamy sand

7.5

20 / 40

83 / 275

-

60

0.995

SFO

silt loam

5.8

20 / 40

152 / 504

-

92

0.996

SFO

Geometric mean

106 / 350

 

70

 

Median

93 / 309

 

63

 

 

 

Field studies ‡

Difenoconazole

 

Soil type (indicate if bare or cropped soil was used).

Location

g/ha1

pH

 

Depth (cm)2

DT50 (d)

actual

DT90(d)

actual

St.

(r2)

DT50 (d)

Norm. 20ºC

Method of calculation

silt loam

bare

Germany

>>250

7.4

0-20

160

532

0.853

-

SFO

silt loam

bare

Germany

500

6.6

0-20

22

72

0.963

-

SFO

loamy sand

bare

Germany

500

6.2

0-20

57

189

0.817

-

SFO

silt loam

bare

Germany

500

6.8

0-20

64

211

0.885

-

SFO

loamy sand

bare

Germany

500

5.6

0-30

63

211

0.766

-

SFO

sandy loam

bare

Germany

750

6.0

0-20

265

879

0.752

-

SFO

silt loam

bare

Germany

750

6.0

0-20

241

802

0.652

-

SFO

silt loam

bare

Germany

750

5.7

0-20

116

384

0.810

-

SFO

clay loam

bare

Switzerland

125

7.3

0-10

83

277

0.934

-

SFO

clay

bare

UK

375

7.6

0-10

1562

5192

0.844

-

SFO

clay

bare

UK

125

7.6

0-10

2272

7552

0.827

-

SFO

sandy loam

bare

Spain

800

-

0-10

542

1782

0.777

-

SFO

sandy loam

bare

Spain

150

-

0-10

382

1282

0.937

-

SFO

sandy clay

bare

UK

375

8.2

0-10

1332

4422

0.840

-

SFO

loam

asparagus

Italy

6x125

-

0-30

1812

6022

0.750

-

SFO

clay

treated seed

Canada

40

7.7

0-10

872

2892

0.741

-

SFO

clay loam

treated seed

Canada

37

6.6

0-10

282

922

0.895

-

SFO

clay

treated seed

Canada

36

8.3

0-10

762

2542

0.902

-

SFO

clay loam

treated seed

Canada

36

6.1

0-10

342

1142

0.821

-

SFO

Geometric mean

92

307

 

Median

83

277

 

1 Treatment rate (g a.s./ha) used in studies.

2 Indicates depth considered, however, residues possible to quantify were sometimes only found in the top soil horizon.

3 Values not included in the mean/median because studies were only considered to be of supplementary nature, or because study was performed on treated seeds. (NB Ctgb in table footnote 2 was used where it should read footnote 3, Ctgb corrected this)

NL comment: In Vol. 1, it was stated that 9 reliable field studies and 13 supplementary studies are available. In the List of Endpoints, 19 studies are mentioned in the table (from which 10 are considered supplementary). Please clarify. From Vol. 3 it is seen that these 3 additional studies were not even suitable to derive DT50 endpoints. It would be helpful if this was also stated in the List of Endpoints and in Vol 1 as well). For the 10 supplementary studies mentioned in the List of Endpoints table, a footnote is added with number 2. This should read 3 to correspond with the footnote text.


 

Additional field dissipation data submitted for NL application for authorisation (see EPP report 090401 versie 2)

Test substance

Type of test

Soil

Application rate

[kg a.s./ha]

DT50

field

[d]

DT50

20 °C

[d]

Difenoconazole*

Field dissipation

Loamy sand

0.498

81 (FOMC)**

153 (SFO)

84 (DFOP)

103**

143

103

* Applied as Score 250 EC (A-7402 G), containing 263 g difenoconazole/L. ** Best fit.

 

Additional field dissipation data submitted for NL application for authorisation (see RIVM report 11959)

Substance

Location

Soil type

Crop

Time of

application

Dose

 

[g as/ha]

 

OM

 

[%]

pH

Duration

 

[d]

SFO

DT50

 

[d]

A-7402 G

Vouvry, Switzerland

loamy sand

bare soil

09-06-2003

500

2.0

7.5

451

153

A-7402 G

Elne, Southern France

sandy silt

bare soil

21-05-2003

500

3.4

6.8

474

63.1

NB The Switzerland trial can be considered representative for NL conditions, the S-France site is not.

 

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

No

Soil accumulation and plateau concentration ‡

 

No accumulation observed after up to 10 years use.

 

 

Additional field accumulation data submitted for NL application for authorisation (see EPP report 090401 versie 2)

Test substance

Type of test

Soil

Crop

Application rate

[kg a.s./ha]

Residues at end of study

(0-30 cm)

Difenoconazole*

5-Years soil residues

Loam

Carrot

4 x 0.125 kg a.s./ha per year**

Difenoconazole  0.052 mg/kg

CGA205375       0.011 mg/kg

1,2,4-triazole      0.011 mg/kg

 

* Applied as Score 250 EC (A-7402 G or A-7402 T), containing 263 or 254 g difenoconazole/L.

** Less applications and lower amounts applied in the first year.

 


Additional field accumulation data submitted for NL application for authorisation (see RIVM report 11959)

Substance

Location

Soil type

Crop

Time of

application

Number of

applications

Dose

 

[g as/ha]

 

OM

 

[%]

pH

 

[H2O]

Duration

 

[y]

Max.

Residue *

difeno-conazole

 

[g as/ha]

Max. residue

CGA 205375

[g as/ha]

Max. residue

CGA 71019

[g as/ha]

A-7402 G

Vouvry, Switzerland

loam

bare soil

2001

2

50/25

2.2

7.4

5 years

62

0

7

A-7402 G

Vouvry, Switzerland

loam

carrot

2002

4

125

2.2

7.4

114

0

4

A-7402 G

Vouvry, Switzerland

loam

carrot

2003

4

125

2.2

7.4

180

0

11

A-7402 G

Vouvry, Switzerland

loam

carrot

2004

4

125

2.2

7.4

196

17

13

A-7402 G

Vouvry, Switzerland

loam

carrot

2005

4

125

2.2

7.4

173

16

15

* residue in sum of 0-10, 10-20, 20-30 cm layer

 

 


Laboratory studies ‡

Difenoconazole

Anaerobic conditions

Soil type

g/ha1

pH

t. oC / % MWHC

DT50 / DT90 (d)

DT50 (d)

20 °C pF2/10kPa

St.

(r2)

Method of calculation

loam

128

7.2

20 / flooded

stable

-

-

-

Geometric mean/median

-

-

 

1 Test concentration re-calculated into corresponding g a.s./ha dose for comparison with the representative uses.

 

 

CGA 71019

Anaerobic conditions

Soil type

 

pH

t. oC / % MWHC

DT50/ DT90
(d)

f. f.    kdp/kf

DT50 (d)

20°C pF2/10kPa

St.

(r2)

Method of calculation

silt loam

7.3

20 / flooded

81 / 268

-

-

0.972

SFO

Geometric mean/median

-

-

-

 

 

 

CGA 205375

Anaerobic conditions

Soil type

 

pH

t. oC / % MWHC

DT50/ DT90
(d)

f. f.    kdp/kf

DT50 (d)

20°C pF2/10kPa

St.

(r2)

Method of calculation

sandy loam/loamy sand

7.5

20 / flooded

213 / 706

-

-

0.986

SFO

Geometric mean/median

-

-

-

 

 


 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Difenoconazole 

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

sand

0.36

7.9

-

-

12.8

3870

0.74

sandy loam

1.98

7.8

-

-

63.0

3520

0.76

silt loam

1.74

6.5

-

-

54.8

3470

0.85

silty clay loam

0.67

6.9

-

-

47.2

7730

0.91

clay

2.79

5.9

-

-

97.8

3470

0.89

sand

0.52

6.5

-

-

2.1

400

0.80

silt loam

0.58

7.5

-

-

35.0

5660

0.88

sandy loam

0.58

8.5

-

-

11.5

1960

0.94

Arithmetic mean

40

3760

0.85

Median

41

3495

0.87

pH dependence, Yes or No

No

 

 

CGA 71019 ‡

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

silty clay

0.70

8.8

-

-

0.83

120

0.90

clay loam

1.74

6.9

-

-

0.75

43

0.83

silty clay loam

0.70

7.0

-

-

0.72

104

0.92

sandy loam

0.81

6.9

-

-

0.72

89

1.02

Arithmetic mean

0.75

89

0.91

Median

0.74

82

0.91

pH dependence (yes or no)

No

 

Agreed endpoint (from PRAPeR 12)

Metabolite 1,2-4 triazole

Soil Type(USDA)

OC %

Soil pH

(CaCl2)

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

Silty clay

0.70

8.8

 

 

0.833

120

0.897

Clay loam

1.74

6.9

 

 

0.748

43

0.827

Sand

0.12

4.8

 

 

0.234

202

0.8851

Silty clay loam

0.70

7.0

 

 

0.722

104

0.922

Sandy loam

0.81

6.9

 

 

0.720

89

1.016

Arithmetic mean (of 4 values excluding the very low OC sand that was considered not representative of agricultural soils)

0.756

89

0.9155

pH dependence (yes or no)

No

 


 

CGA 205375 ‡

Soil Type

OC %

Soil pH

Kd (mL/g)

Koc

(mL/g)

Kf

(mL/g)

Kfoc

(mL/g)

1/n

loamy sand

2.17

5.7

-

-

118

5440

0.81

silty clay loam

1.16

6.6

-

-

45.5

3920

0.76

clay

2.63

6.7

-

-

44.1

1680

0.76

sandy loam

1.17

6.8

-

-

22.6

1930

0.72

loam

1.22

7.6

-

-

23.6

1930

0.77

Arithmetic mean

51

2980

0.76

Median

44

1930

0.76

pH dependence (yes or no)

No

 

 

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching ‡

 

Eluation: 200 mm

Time period: 2 d

Difenoconazole did not move out of the zone of application in any of four soils tested.

Study used only to support results from adsorption/desorption tests.

Aged residues leaching ‡

Not submitted, not required

 

 

 

Lysimeter/ field leaching studies ‡

 

Not submitted, not required

 

 

Route and rate of degradation in water (Annex IIA, point 7.2.1)

Hydrolytic degradation of the active substance and metabolites > 10 % ‡

Difenoconazole: No degradation observed at pH 5, 7 and 9 (25ºC, 30 days)

 

 

CGA 71019: No degradation observed at pH 5, 7 and 9 (25ºC, 30 days)

 

CGA 205375: No degradation observed at pH 4, 7 and 9 (50ºC, 5 days)

Photolytic degradation of active substance and metabolites above 10 % ‡

 

Difenoconazole: Stable (<10% transformation over 15 days, continuous irradiation)

 

CGA 205375: Stable (<10% transformation over 15 days, continuous irradiation)

Quantum yield of direct phototransformation in water at  λ> 290 nm

0.0155.

Predicted half-lives were between 12 and >10000 years at 52ºN latitude depending on season.

 

CGA 205375: 0.0266.

Predicted half-lives were between 14 and >10000 years at 52ºN latitude depending on season.

Readily biodegradable ‡
(yes/no)

No

 

 

Degradation in water / sediment

Difenoconazole

Distribution of total radioactivity in Pond/River systems (20ºC):

Max. in water 88/80% day 0. Decreased to 20/32% by day 3 and to <10% by day 7/14.

Distribution of Difenoconazole in Pond/River systems (8ºC):

Max. in water 83/87% day 0. Decreased to 15/36% by day 3 and to 2.3/12% by day 14.

Max. in sediment 99.8/96.5% day 42.

 

Metabolites identified (20ºC, 14C-chlorophenyl label):

CGA 205375 max. 4.9% in pond system (days 32 and 127),

max. 11.6-11.4% in river system (days 90-183).

Water / sediment system

pH

water phase

pH sed

t. oC

DT50/DT90 whole sys.

Degradation

St.

(r2)

DT50/DT90

water

Dissipation

St.

(r2)

DT50- DT90

sed

St.

(r2)

Method of calculation

 

Pond

-

6.9

20

ca 324/>1000

0.998

1.0 / 3.3

0.987

-

 

SFO

 

River

-

7.2

20

ca 307/>1000

0.999

2.0 / 6.6

0.968

-

 

SFO

 

Pond

-

7.2

8

DT50 ca 3 y1

-

1.0 / 3.4

0.991

-

 

SFO

 

River

-

7.2

8

DT50 ca 2 y1

-

0.8 / 6.2

0.999

-

 

SFO

 

Geometric mean

315 / >1000

 

1.1 / 4.6

 

-

 

 

1 DT50 values related to degradation in whole systems obtained at 8ºC were not included in mean value.

 

CGA 205375

Distribution of CGA 205375 in Pond/River systems:

Max. in water 97/96% day 0. Decreased to <10% by day 7/14. Max. in sediment 91/87% day 62/28.

 

Metabolites identified (14C-triazole label):

CGA 71019 max. 3.2% in pond system (day 148),

max. 14.1% in river system (day 148).

Water / sediment system

pH water phase

pH sed

t. oC

DT50-DT90 whole sys.

Degradation

St.

(r2)

DT50-DT90

water

Dissipation

St.

(r2)

DT50- DT90

sed

St.

(r2)

Method of calculation

Pond

7.97

7.09

20

ca 630/>1000

0.765

1.4 / 4.7

0.958

-

-

SFO

River

8.1

7.46

20

ca 301/>1000