Toelatingsnummer 11453 N

Score 250 EC

 

11453 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 UITBREIDING TOELATING

 

Gelet op de aanvraag d.d. 27 maart 2008 (20080291 UG) van

 

Syngenta Crop Protection B.V.

Jacob Obrechtlaan 3 a

4611 AP BERGEN OP ZOOM

 

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

 

Score 250 EC

 

gelet opartikel 23, 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 als schimmelbestrijdingsmiddel voor professioneel gebruik in de teelt van voederbieten, winterkoolzaad, appels en peren. Voor de gronden waarop dit besluit berust 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 artikel 36 van de Wet milieugevaarlijke stoffen 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:

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

 

 

Veiligheidsaanbevelingen:

Niet roken tijdens gebruik.

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

 

Specifieke vermeldingen:

 

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:

 

         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
.

 

1.      bij het toelatingsnummer een cirkel met daarin de aanduiding W.5.

 

2 DETAILS VAN DE AANVRAAG

 

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. Het middel is reeds toegelaten als schimmelbestrijdingsmiddel voor professioneel gebruik:

a)      in de teelt van suikerbiet;

b)      in de teelt van knolselderij en bleekselderij;

c)      in de teelt van snijselderij en peterselie;

d)      in de teelt van bloemkool, broccoli, sluitkool en spruitkool, mits niet vaker dan drie keer toegepast;

e)      in de teelt van asperge;

f)        in de teelt van peen.

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 toelating als schimmelbestrijdingsmiddel voor professioneel gebruik in de teelt van voederbieten, winterkoolzaad, appels en peren gevraagd.

 

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 (richtlijn 2008/69/EG
d.d. 1 juli 2008). 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 31 maart 2008 ontvangen; op 1 april 2008 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 3 november 2008 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

De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van de evaluatie van het middel en de stof staat beschreven in Hoofdstuk 2, Physical and Chemical Properties, in Bijlage II bij dit besluit.

 

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten. De residuen die het gevolg zijn van geoorloofd gebruik die in toxicologisch opzicht of vanuit milieu oogpunt van belang zijn, kunnen worden bepaald met algemeen gebruikte passende methoden (artikel 28, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van de evaluatie van de analysemethoden staat beschreven in 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 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, voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het aspect werkzaamheid staat beschreven in Hoofdstuk 8, Efficacy, in Bijlage II bij dit besluit.

 

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 juni 2009

 

 

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 juni 2009 tot 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:

a) teelt van suikerbieten en voederbieten

b) teelt van winterkoolzaad

c) teelt van appels en peren

d) onbedekte teelt van bloemkool, broccoli, sluitkool en spruitkool

e) onbedekte teelt van knolselderij en bleekselderij

f) teelt van snijselderij en peterselie

g) teelt van bospeen, waspeen en winterwortelen

h) onbedekte teelt van asperges

 

Per teelt zijn maximaal 2 toepassingen toegestaan in suikerbieten, voederbieten, winterkoolzaad, bloemkool, broccoli, snijselderij en peterselie, 4 toepassingen in appels en peren en 3 toepassingen in de overige vermelde gewassen.

 

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 n 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 nzijdige 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 nzijdige bespuiting van de laatste bomenrij en een maximale hoeveelheid spuitvloeistof van 1400 liter per ha.

 

Op percelen die grenzen aan oppervlaktewater is toepassing in de onbedekte teelt van suikerbiet, voederbiet, winterkoolzaad, bloemkool, broccoli, sluitkool, spruitkool, knolselderij, bleekselderij, snijselderij, peterselie, bospeen, waspeen, winterwortelen en asperges uitsluitend toegestaan met gebruik van doppen uit de driftreductieklasse 75%.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

Veiligheidstermijn:

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

14 dagen voor bloemkool, broccoli, bospeen, waspeen en winterwortelen

14 dagen voor snijselderij en peterselie

21 dagen voor knolselderij en bleekselderij

21 dagen voor rode kool, savooie kool, witte kool, spitskool en spruitkool

28 dagen voor appels, peren, suikerbieten en voederbieten

 

 

 

 


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 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.

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.

Dosering: 0,5 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.

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

 

Bloemkool en 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.

Dosering: 0,5 liter middel per ha

 

 


Sluitkool (rode kool, savooie 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.

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.

Dosering: 0,5 liter middel per ha

 

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.

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.

Dosering: 0,4 liter middel per ha

 

Bospeen, waspeen en winterwortelen, ter bestrijding van loofverbruining (Alternaria dauci).

Een behandeling uitvoeren zodra een eerste aantasting wordt waargenomen. Eventuele volgende behandelingen met een interval van 2 weken.

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.

Dosering: 0,5 liter middel per ha

 

 

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 5 juni 2009 tot uitbreiding van de toelating van het middel
Score 250 EC, toelatingnummer 11453 N

 

 

BIJLAGE II RISKMANAGEMENT

 

 

 

Contents Page

 

 

1. Identity of the plant protection product 2

 

2. Physical and chemical properties 3

 

3. Methods of analysis 8

 

4. Mammalian toxicology 10

 

5. Residues 17

 

6. Environmental fate and behaviour 24

 

7. Ecotoxicology 56

 

8. Efficacy 84

 

9. Conclusion 88

 

10. Classification and labelling 88

 


1. Identity of the plant protection product

 

1.1 Applicant

Syngenta Crop Protection B.V.

Jacob Obrechtlaan 3a

4611 AP Bergen op Zoom

 

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

 

The active substance was included on January 1, 2009 in Annex I of Directive 91/414/EEC.

 

 

1.3              Identity of the plant protection product

Name

Score 250 EC

Formulation type

EC

Content active substance

250 g/L

 

The formulation is identical to that assessed for the inclusion of the active substance in Annex I of Directive 91/414/EEC.

 

 

1.4 Function

Fungicide.

 

1.5 Uses applied for

Score 250EC is claimed for the already authorized uses and an extension to Cercospora beticola on fodder beet, Leptosphaeria magulans on oil seed rape, Venturia inaequalis on apple and Venturia pirina on pear. See table of authorized uses in Appendix 1 for further information on uses applied for.

 

1.6 Background to the application

It concerns an extension of the authorization.

 

1.7 Packaging details

 

1.7.1 Packaging description

Material:

Co-extruded high density PE/PA (1 and 5 L) or

Fluorinated polyethylene (5 L )

Capacity:

1 L and 5 L

Type of closure and size of opening:

Screw cap closure (50 mm diameter) with tamper evident ring (1 l) or

Screw cap closure (63 mm diameter) with induction heat seal and tamper evident ring (5 l)

Other information

Not applicable

 

1.7.2 Detailed instructions for safe disposal

See application form and MSDS (no particular recommendations).

 

 

2.                  Physical and chemical properties

 

2.1              Active substance: difenoconazole

Data on the identity is taken from the List of Endpoints (Review report 2008). Changes and/or additions are taken up in italics.

Identity

Active substance (ISO Common Name)

Difenoconazole

Chemical name (IUPAC)

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

Chemical name (CA)

1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-

2-ylmethyl]-1H-1,2,4-triazole

CIPAC No

Not allocated

CAS No

119446-68-3

EEC No (EINECS or ELINCS)

Not allocated

FAO Specification (including year of publication)

No FAO specification available.

Minimum purity of the active substance as manufactured (g/kg)

940 g/kg

 

Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)

Difenoconazole as manufactured does not contain any relevant impurities.

 

Molecular formula

C19H17Cl2N3O3

Molecular mass

406.3 g/mol

Structural formula

 

 

Data on the physical and chemical properties of the active substance is taken from the DAR (May 2006; Updated December 2006). Changes and/or additions are taken up in italics.

Physical-chemical properties

Melting point (state purity)

82.0-83.0C (99.3%)

Boiling point (state purity)

Not relevant at atmospheric pressure as decomposition occurs.

100.8C at 3.7 mPa (99.3%)

Temperature of decomposition

Decomposition starts at about 337C (99.3%)

Appearance (state purity)

Technical material: Off-white powder with a slightly sweetish odour, purity not stated.

Purified material: White fine odourless crystalline powder,

purity 99.3 %

Relative density (state purity)

density = 1.39 g/ml bij 22 C (99.3 %)

Surface tension

62.8 mN/m at 20C (90 % saturated solution)(94.6%)

Vapour pressure (in Pa, state temperature)

3.32 x 10-8 Pa at 25C (99.0%)

Henrys law constant (in Pam3mol-1)

9.0 x 10-7 Pa m3 mol -1

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

15 mg/l 1.3 mg/l at pH 7.2 and 25 C

No pH effect is anticipated at environmentally relevant pH

Solubility in organic solvents (in g/l or

mg/l, state temperature)

Solubility at 25C in g/L (94.6%):

acetone:

>500 g/l

dichloromethane:

>500 g/l

ethyl acetate:

>500 g/l

hexane:

3.0 g/l

methanol:

>500 g/l

octanol:

110 g/l

toluene

>500 g/l

Partition co-efficient (log Pow) (state pH and temperature)

log PO/W = 4.36 0.02 at 25 C and a pH of approx. 8 (99.3%)

No pH effect is anticipated at environmentally relevant pH.

Hydrolytic stability (DT50) (state pH and temperature)

Stable at pH 5, 7 and 9 for 30 days at 25C.

 

Dissociation constant

pKa1 = 1.07 0.18 for the corresponding acid (i.e the neutral species is predominantly present at pH > 1.1) (99.3%)

UV/VIS absorption (max.) (if absorption >290 nm state ε at wavelength)

 

Neutral media:

 

λmax [nm]

215

235

275

 

Acidic media:

 

λmax [nm]

215

235

275

 

Alkaline media:

λmax [nm]

220

235

275

No adsorption maxima between 300 nm and 700 nm at any pH

Photostability (DT50) (aqueous, sunlight, state pH)

Not applicable

Quantum yield of direct photo-

transformation in water at λ > 290 nm

Not applicable (almost no adsorption above 290 nm)

Photochemical oxidative degradation in air

DT50= 4.87 days (26.4 x 10-12 cm3/molecule.sec)

 

Flammability

Flammability: Not highly flammable

Auto-flammability

Auto-flammability: No self-ignition below the melting point

Oxidative properties

Not oxidising (91.8%)

Explosive properties

Not explosive (91.8%)

 

2.2              Plant protection product: Score 250 EC

Data on the plant protection product is taken from the DAR (May 2006; Updated December 2006). Studies submitted by the applicant are in Italics.

The range of the application concentration of the plant protection product is 0.015 - 0.250 %.

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

visual

Liquid

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

visual

Yellow orange

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

organoleptic

Thymol like

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP

EEC A.14

Not explosive

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

GLP

According to Recommendation on the Transport of Dangerous Goods, Manual of Test and

Criteria. Part III, section 34. United Nations, 1995

Not oxidising

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP

EEC A.15

Lowest auto ignition temperature is 445 C

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP

EEC A.9

63 C at 101.3 kPa

Acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

 

Not applicable

 

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC 75.3

1 % in deionised water

pH = 6.3

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

GLP

EEC A.5

100%: 37.0 mN/m (25 C)

1%: 33.7 mN/m (20 C)

0.1%: 35.6 mN/m (20 C)

Acceptable

B.2.2.12 (IIIA 2.5)

Viscosity

GLP

OECD 114

shear rate

(s-1)

viscosity at 20C

(mPa.s)

viscosity at 40C

(mPa.s)

224.5

35

 

1220

40

 

696.9

 

13

1227

 

21

Acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP

OECD 109

 

Density = 1.070 g/cm3

Acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable

 

B.2.2.15 (IIIA 2.7)

Storage stability

GLP

OECD 113

 

 

Stable for 14 days at 54 C in a hermetically closed glass bottle.

 

The a.s. content showed no decrease at all.

Acceptable

 

 

CIPAC MT 39.3

Stable for 7 days at 0 C

 

Properties determined before and after storage: appearance, pH (1 %), emulsion stability

Acceptable

B.2.2.16 (IIIA 2.7)

Shelf life

GLP

Stable for 2 years at 20 C in HDPE/PA

 

Properties determined before and after storage: appearance, pH (1%), density, persitent foaming, emulsion stability, resistence of packaging material

Acceptable

 

 

 

Stable for 2 years at 20 C in fluorinated HDPE

 

Properties determined before and after storage: appearance, pH (1%), density, persitent foaming, emulsion stability, resistance of packaging material

Acceptable

B.2.2.17

(IIIA 2.8)

Wettability

 

Not applicable

 

B.2.2.18 (IIIA 2.8)

Persistent foaming

CIPAC MT 47.2

1% in CIPAC water D

After 10 seconds: 15 ml

After 1 minute: 15 ml

After 3 minutes: 12 ml

After 12 minutes: 10 ml

Acceptable

B.2.2.19

(IIIA 2.8)

Suspensibility

 

Not applicable

 

B.2.2.20

(IIIA 2.8)

Spontaneity of dispersion

 

Not applicable

 

B.2.2.21

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.23

(IIIA 2.8)

Wet sieve test

 

Not applicable

 

B.2.2.24

(IIIA 2.8)

Particle size distribution

 

Not applicable

 

B.2.2.25

(IIIA 2.8)

Content of dust/fines

 

Not applicable

 

B.2.2.26

(IIIA 2.8)

Attrition and friability

 

Not applicable

 

B.2.2.27 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

See IIIA 2.8

 

Acceptable

B.2.2.28

(IIIA 2.8)

Stability of dilute emulsion

CIPAC MT173

Conc

(%)

Cipac water

0.5h

2h

24h

1

A

99

99

88

1

D

100

101

100

0.1

A

98

95

82

0.1

D

100

100

99

 

In all cases the complete stability after re-emulsification after 0.5 h ranges between 97.5 and 101 %.

Acceptable

B.2.2.29

(IIIA 2.8)

Flowability

 

Not applicable

 

B.2.2.30

(IIIA 2.8)

Pourability (rinsibility)

 

Not applicable

 

B.2.2.31

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.32

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable

 

2.9.1

Physical compatibility with other products

 

Not relevant

 

2.9.2

Chemical compatibility with other products

 

Not relevant

 

 

No mixing with other plant protection products or adjuvants is proposed. No information is available on the behaviour of this product when mixed. Mixing with another product or adjuvant can therefore result in unexpected behaviour.

 

Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions.

 

2.3              Data requirements

None.

 

 

3.                  Methods of analysis

 

3.1.            Analytical methods in technical material and plant protection product

 

3.1.1 Difenoconazole

Description and data on the analytical methods is taken from the List of Endpoints. The final List of Endpoints presented below is taken from the DAR (May 2006; Updated December 2006). Where relevant, some additional remarks/information are given in italics.

 

Technical as (principle of method)

GC-FID

Impurities in technical as (principle of method)

Confidential information, see Annex C

Preparation (principle of method)

GC-FID

 

Conclusion

These analytical methods have been assessed in the DAR and are considered to be acceptable.

 

3.2              Residue analytical methods

 

3.2.1 Difenoconazole

 

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

Soil (principle of method and LOQ)

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

Water (principle of method and LOQ)

GC-ECD; LOQ = 0.05 (drinking) 0.1 (surface)

Air (principle of method and LOQ)

HPLC-MS/MS; LOQ = 0.99 ng/L

Body fluids and tissues (principle of method and LOQ)

Not required, non toxic compound

 

 

Based on the proposed use of the plant protection product analytical methods for determination of residues in food/feed of plant origin are required for watery and a special (sugar beet) matrix

 

Definition of the residue and MRLs 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

 

Required LOQ

Soil

Difenoconazole + CGA 205375 (metabolite: final decision on inclusion in the definition of the residue pending additional data expected mid-2006)

0.05 mg/kg (default)

Drinking water

Difenoconazole

0.1 g/L (drinking water guideline)

Surface water

Difenoconazole

0.1 g/L (HTB 1.0)

Air

Difenoconazole

0,06 mg/m3 (derived from the AOEL (0.2 mg/kg bw/day) according to SANCO/825/00

Body fluids and tissues

The active substance is not classified as (very) toxic thus no definition of the residue is proposed.

 

The residue analytical methods, included in the abovementioned List of Endpoints, are suitable for monitoring of the proposed MRLs.

 

The residue analytical methods for water, soil and air, evaluated in the DAR, are acceptable and suitable for monitoring of residues in the environment.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRLs and for monitoring of residues in the environment.

 

3.3 Data requirements

None.

 

3.4 Physical-chemical classification and labelling

 

Proposal for the classification of difenoconazole (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

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:

 

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

 

In the GAP/instructions for use the following has to be stated:

-

 

 

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 at 1 January 2009. The member states commented on the DAR, but the further peer review will be performed in 2009. 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 g/cm2, 12.5 g/cm2 and 2500 g/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 g/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

Score 250 EC is an EC formulation and contains 250 g/L difenoconazole.

The intended uses are listed under 1.5.

 

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.

Since the formulation is applied 1-4 times during a period of less than 3 months with a spray interval of minimally10 days, 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 oilseed rape and fodderbeets

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

Mechanical upward spraying on apples and pears

Mixing/

Loading

Respiratory

0.00

14

<0.01

Dermal

0.02

14

<0.01

Application

Respiratory

0.01

14

<0.01

Dermal

0.77

14

0.05

 

Total

0.80

14

0.06

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 fodder beets and oilseed rape 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 apples and pears it is possible to perform re-entry activities during which intensive contact with the treated crop will occur. 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 in apples and pears

 

Respiratory

-

14

-

Dermal

0.14

14

0.01

 

Total

0.14

14

0.01

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 fodder beets, oilseed rape, apples and pears.

 

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 fodder beets, oilseed rape, apples and pears.

 

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 fodder beets, oilseed rape, apples and pears 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 identifed.

 

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 in 2009. 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 <‑20C for at least 24 months.

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

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

 

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

Intakes by livestock 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 12132A00 (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.

 

5.1.4 Stability of residues

No new data has been submitted. See the List of Endpoints. In studies submitted nationally and summarised for previous applications for authorisations, difenoconazole was proven to be stable in various products of plant products (lettuce, soy beans, wheat grain and straw, cottonseed, cottonseed oil, cotton seed cake, apples and grapes) and metabolite mB was proven to be stable in apples and grapes, both substances for 2-years when stored at 20C. In animal products (tissues, milk and eggs) difenoconazole is stable for at least 1-year and mB is stable for at least 1-year in tissues and stable for at least 9-months in milk, all when stored at 20C.

 

Sugar beets are considered to have a separate matrix, storage stability studies for this specific matrix should be submitted. However, since difenoconazole was proven to be stable in various matrices (fat, water, dry), the stability of difenoconazole was demonstrated sufficiently.

 

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.

 

Fodder beets

Applicant submitted five supervised residue trials in sugar beet. As the cGAP (2x 0.1 kg as/ha, int 14d, PHI 28d) is the same for both sugar beets and fodder beets, results from supervised residue trials in sugar beet performed in accordance with the cGAP, can be extrapolated to fodder beets. 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.

 

Oilseed rape (winter)

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.

 

Apples and pears

Several reports containing supervised residue trials in apples and pears have been submitted and are available in the summary by Germany and in the DAR. The cGAP-NL (4x 0.0375 kg as/hL and 0.056 kg as/ha in apple and 0.045 kg as/ha in pear, int 10d, PHI 28d) is equal to the cGAP-NEU. Nine trials performed in N-EU are available (two decline trials in apple, one decline trial in pears, five harvest trials in apples and one harvest trial in pears) and were performed in accordance with cGAP. Apples and pears are major crops, eight trials in apples and pears with a minimum of four apple trials are sufficient to cover the whole group of pome fruit.

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

 

Table R1: Selected residue levels from trials with difenoconazole

Crop

Residue levels selected for MRL setting (mg/kg)

STMR

(mg/kg)

HR

(mg/kg)

Sugar beet roots

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

<0.02

0.1

Sugar beet leaves

0.06, 0.084, 0.087, 0.09, 0.204, 0.247, 0.25 (2x), 0.26, 0.41, 0.43 (2x), 0.47, 0.49, 0.53, 0.60# (2x), 0.62, 0.74

0.41

0.74

Apples

0.02, 0.04, 0.05 (2x), 0.06, 0.07

0.05

0.07

Pears

0.01, 0.05, 0.07

0.05

0.07

Winter rape

<0.02 (6x)

<0.02

<0.02

Spring rape

<0.02

<0.02

<0.02

 

5.1.7 Residues from livestock feeding studies

Two new livestock feeding studies have been submitted for this application; a feeding studies in dairy cows and one in laying hens

 

Tables R2 to R5 contain details of the difenoconazole animal dietary exposure calculations for dairy cattle, beef cattle, poultry and pigs.

 

Table R2: Calculation of Difenoconazole Dietary Intake by Dairy Cattle

Bodyweight (kg): 550

Daily Maximum Feed (kg dry matter): 20

Group and
Feed Item

% of diet

% DM[1] in crop

FM intake (kg FM/animal/day)

Residue

(mg/kg)

Residue intake

(mg/ani-mal/day)

Residue intake

(mg/kg BW/day)

Residue intake

(mg/kg DM diet)

I Kale/Cabbage

35

14

50.000

2

100.0

0.1818

5.00

V Sugar Beet Root

30

20

30.000

0.05

1.500

0.0027

0.075

VI Oilseed (meal, cake)

30

86

6.980

0.5

3.488

0.0063

0.174

 

95

 

5.249

 

Table R3: Calculation of Difenoconazole Dietary Intake by Beef Cattle

Bodyweight (kg): 350

Daily Maximum Feed (kg dry matter): 15

Group and
Feed Item

% of diet

% DM1 in crop

FM intake (kg FM/animal/day)

Residue

(mg/kg)

Residue intake

(mg/ani-mal/day)

Residue intake

(mg/kg BW/day)

Residue intake

(mg/kg DM diet)

I Kale/Cabbage

35

14

37.500

2

75.00

0.214

5.00

V Sugar Beet Root

35

20

26.250

0.05

1.313

0.0038

0.088

VI Oilseed (meal, cake)

30

86

5.230

0.5

2.616

0.0075

0.174

 

100

 

5.262

 

Table R4: Calculation of Difenoconazole Dietary Intake by Poultry

Bodyweight (kg): 1.9

Daily Maximum Feed (kg dry matter): 0.12

Group and
Feed Item

% of diet

% DM1 in crop

FM intake (kg FM/animal/day)

Residue

(mg/kg)

Residue intake

(mg/ani-mal/day)

Residue intake

(mg/kg BW/day)

Residue intake

(mg/kg DM diet)

I Kale/Cabbage

5

14

0.04

2

0.086

0.0453

0.717

V Sugar Beet Root

20

20

0.12

0.05

0.006

0.0032

0.050

VI Oilseed (meal, cake)

10

86

0.01

0.5

0.007

0.0037

0.058

 

35

 

0.825

 

Table R5: Calculation of Difenoconazole Dietary Intake by Pigs

Bodyweight (kg): 75

Daily Maximum Feed (kg dry matter): 3

Group and
Feed Item

% of diet

% DM1 in crop

FM intake (kg FM/animal/day)

Residue

(mg/kg)

Residue intake

(mg/ani-mal/day)

Residue intake

(mg/kg BW/day)

Residue intake

(mg/kg DM diet)

I Kale/Cabbage

15

14

3.21

2

6.429

0.0857

2.143

V Sugar Beet Root

60

20

9.00

0.05

0.450

0.0060

0.150

VI Oilseed (meal, cake)

20

86

0.07

0.5

0.349

0.0047

0.116

 

95

 

2.409

 

As the dietary burden calculation shows that the threshold value of 0.1 mg/kg dry feed is exceeded, feeding studies in cattle and poultry are required. As metabolism in ruminants and rat is similar, the results of feeding studies in cattle can be extrapolated to pigs.

 

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

In the three supervised residue trials in oil seed rape, summarised in report 12132A00, residues in the processed products, i.e. in dried seed, in oil and in press cake, were also studied. It is reported in these studies that no residues were found in these products (all below the limit of quantification: <0.02 mg/kg). Since residues in the seeds are already below the LOQ, no processing studies are requested. The processing data are therefore not evaluated.

 

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

Residue levels found in tissues, milk and eggs at the 1N and 1.2N dose rate in dairy cows and laying hens, respectively are all covered by the temporary EU-MRLs for difenoconazole in animal products.

Residue levels found in sugar beet (roots), rape seed, apples and pears are covered by the temporary EU-MRLs for these crops.

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 product complies with the MRL Directives/Regulation. Notification of revised MRLs is not necessary.

 

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 STMRs/HRs for oilseed rape, apples, pears and animal products. The highest percentage of the ESTI is 24.5 % of the ARfD for apples for the UK infants. ESTI values for the other commodities are all lower.

 

Conclusion

The product complies with the Uniform Principles.

 

5.4 Data requirements

No data requirements were indentified.

 

 

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 end points

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[2]

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 10/30C, 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)

20C 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 Endpoint 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. 20C

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