HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 13246 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 BESLUIT Op 28 juli 2015 is van Certis Europe BV Postbus BD MAARSSEN een aanvraag tot uitbreiding kleine toepassing van gewasbeschermingsmiddeltoelating ontvangen voor het middel op basis van de werkzame stof pyraflufen-ethyl. Quickdown HET COLLEGE BESLUIT tot uitbreiding van bovenstaand middel. Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit. Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen: - Bijlage I voor details van de aanvraag en toelating. - Bijlage II voor de etikettering. - Bijlage III voor wettelijk gebruik. - Bijlage IV voor de onderbouwing. 1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2 Gebruik Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven. 1.3 Classificatie en etikettering Mede gelet op de onder wettelijke grondslag vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld: Quickdown, NLKUG 1

2 13246 N - De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder verpakkingsinformatie in bijlage I bij dit besluit. - Het toelatingsnummer met een cirkel met daarin de aanduiding van de W-codering zoals vermeld onder toelatingsinformatie in bijlage I bij dit besluit. - De etikettering zoals opgenomen in bijlage II bij dit besluit. - Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III bij dit besluit. - Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. 1.4 Aflever- en opgebruiktermijn (respijtperiode) Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt. 2 WETTELIJKE GRONDSLAG Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en artikel 2.2 Rgb Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader HTB0.2 of nieuwer 3 BEOORDELINGEN 3.1 Fysische en chemische eigenschappen De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof wijzigen niet. 3.2 Analysemethoden De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten toepassingen voldoen de vereiste residuanalysemethoden. 3.3 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht. 3.4 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht. 3.5 Werkzaamheid Gelet op artikel 51 Verordening (EG) 1107/2009 is de aanvraag niet beoordeeld voor het aspect werkzaamheid (inclusief fytotoxiciteit). Quickdown, NLKUG 2

3 13246 N Bezwaarmogelijkheid Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Ede, 23 december 2015 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, Ir. J.F. de Leeuw Voorzitter Quickdown, NLKUG 3

4 13246 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: NLKUG Type aanvraag: aanvraag tot uitbreiding kleine toepassing van gewasbeschermingsmiddel Middelnaam: Quickdown Formele registratiedatum: * 28 juli 2015 Datum in behandeling name: 4 november 2015 Datum compliance check: N.v.t. * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof pyraflufen-ethyl Gehalte 26,5G/L De stof pyraflufen-ethyl is per 1 november 2001 geplaatst op Annex I van Richtlijn 91/414/EEG (01/87/EC) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd en verlengd Reg. 2015/1885 d.d. 20 oktober De goedkeuring van deze werkzame stof expireert op 30 juni Toelatingsinformatie Toelatingsnummer: N Expiratiedatum: 1 januari 2020 Afgeleide of parallel: n.v.t. Biocide, gewasbeschermingsmiddel of Gewasbeschermingsmiddel toevoegingsstof: Gebruikers: Professioneel W-codering professioneel gebruik: 5 4 Aflever- en opgebruiktermijnen voor oude etiket Vorige W-codering professioneel gebruik: 4 Aflevertermijn professioneel gebruik: nvt Opgebruiktermijn professioneel gebruik: nvt 5 Verpakkingsinformatie Aard van het preparaat: Emulgeerbaar concentraat Quickdown, NLKUG 1

5 13246 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Quickdown Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: pyraflufen-ethyl Pictogram Signaalwoord Gevarenaanduidingen Voorzorgsmaatregelen Aanvullende etiketelementen Kinderveilige sluiting verplicht Voelbare gevaarsaanduiding verplicht GHS05 GHS07 GHS09 GEVAAR H315 Veroorzaakt huidirritatie. H317 Kan een allergische huidreactie veroorzaken. H318 Veroorzaakt ernstig oogletsel H332 Schadelijk bij inademing. H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen. P202 Pas gebruiken nadat u alle veiligheidsvoorschriften gelezen en begrepen heeft. P260 Stof/rook/gas/nevel/damp/spuitnevel niet inademen. P262 Contact met de ogen, de huid of de kleding vermijden. P271 Alleen buiten of in een goed geventileerde ruimte gebruiken. P273 Voorkom lozing in het milieu. P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen. Nee Nee Quickdown, NLKUG 1

6 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als onkruidbestrijdingsmiddel en loofdoodmiddel in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden Toepassingsgebied Pootaardappel Pootaardappel (geklapt) Consumptieaardappel doodspuiten, volveldsbehandeling doodspuiten, rijenbehandeling doodspuiten, volveldsbehandeling doodspuiten, volveldsbehan- Zetmeelaardappel Type behandeling Te bestrijden organisme deling Aardappelen Voor opkomst éénjarige breedbladige onkruiden Dosering (middel) per toepassing 1 Spuitvolume aanpassen aan de gewasontwikkeling ( L/ha). 2 in combinatie met 2 L minerale olie of koolzaadolie per ha 3 in combinatie met 1 L minerale olie of koolzaadolie per ha Maximaal aantal toepassingen per teeltcyclus Maximaal aantal liter middel per ha per teeltcyclus Minimum interval tussen toepassingen in dagen Veiligheidstermijn in dagen aardappelloof 0,8 L/ha 1,2 2 1,6 L/ha 5 14 aardappelloof 0,4 L/ha aardappelloof 0,8 L/ha 2 2 1,6 L/ha 5 14 aardappelloof 0,8 L/ha 2 2 1,6 L/ha ,4 L/ha 3 1 0,4 L/ha - - Page 2

7 Het gebruik in de onbedekte teelt van steenvruchten, aardbei, bessen, druiven, braam- en framboos-achtigen, noten, vijg, kiwi, asperges, bloemisterijgewassen, vaste plantenteelt en veredelingsteelt en bloemenzaadteelt, groentenzaadteelt en zaadteelt van fruitgewassen, kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemestersgewassen, voedergewassen en witlof, cichorei, boekweit en meekrap is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheid van de gebruiker. Toepassingsgebied Steenvruchten (onbedekte teelt) Aardbei (onbedekte teelt) Bessen (onbedekte teelt) Druiven (onbedekte teelt) Braam- en framboosachtigen (Rubus spp.) (onbedekte teelt) Type toepassing In of tussen de rijen met afschermkap Tussen de rijen met afschermkap In of tussen het gewas met afschermkap In of tussen het gewas met afschermkap In of tussen het gewas met afschermkap Te bestrijden organisme éénjarige breedbladige onkruiden éénjarige breedbladige onkruiden Dosering (middel) per toepassing Maximaal aantal toepassingen per teeltcyclus Maximaal aantal liter middel per ha per teeltcyclus Minimum interval tussen toepassingen in dagen 0,8 L/ha 1) 2 1,6 L/ha 21 0,8 L/ ha 1) 2 1,6 L/ha 21 wortelopslag 0,8 L/ha 1) 2 1,6 L/ha 21 éénjarige breedbladige onkruiden 0,8 L/ha 1) 2 1,6 L/ha 21 zijscheuten éénjarige breedbladige onkruiden wortelopslag 0,8 L/ ha 1) 2 1,6 L/ha 21 éénjarige breedbladige onkruiden Page 1

8 Toepassingsgebied Type toepassing Te bestrijden organisme Dosering (middel) per toepassing Maximaal aantal toepassingen per teeltcyclus Maximaal aantal liter middel per ha per teeltcyclus Minimum interval tussen toepassingen in dagen Noten In of tussen het gewas met afschermkap éénjarige breedbladige onkruiden 0,8 L/ ha 1) 2 1,6 L/ha 21 Kiwi (onbedekte teelt) In of tussen het gewas met afschermkap éénjarige breedbladige onkruiden 0,8 L/ ha 1) 2 1,6 L/ha 21 Asperge (onbedekte teelt) Tussen de rijen éénjarige breedbladige onkruiden 0,8 L/ ha 1) 2 1,6 L/ha 21 Bloemisterijgewassen (onbedekte teelt) Vaste plantenteelt (onbedekte teelt) Veredelingsteelt en bloemenzaadteelt en zaadteelt van fruitgewassen, kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemestersgewassen, voedergewassen en witlof, cichorei, boekweit en meekrap (onbedekte teelt) Tussen het gewas met afschermkap Tussen het gewas met afschermkap Tussen het gewas met afschermkap éénjarige breedbladige onkruiden éénjarige breedbladige onkruiden éénjarige breedbladige onkruiden 0,8 L/ ha 1) 2 1,6 L/ha 14 0,8 L/ ha 1) 2 1,6 L/ha 14 0,8 L/ ha 1) 2 1,6 L/ha 14 Page 2

9 Toepassingsgebied Type toepassing Te bestrijden organisme Dosering (middel) per toepassing Maximaal aantal toepassingen per teeltcyclus Maximaal aantal liter middel per ha per teeltcyclus Minimum interval tussen toepassingen in dagen 1) in combinatie met 1 L minerale olie of koolzaadolie per ha. Toepassingsvoorwaarden Bij de toepassing in pootaardappel met een sterke groeikracht of een sterke loofontwikkeling is het, teneinde een goed resultaat te verkrijgen, raadzaam eerst het gewas open te spuiten met een daarvoor geschikt en toegelaten loofdoodmiddel. 5 tot 7 dagen later Quickdown toepassen. Indien nodig behandeling met Quickdown herhalen. In de teelt van steenvruchten, aardbei, bessen, druiven, braam- en framboos-achtigen (Rubus spp.), noten, kiwi, asperge, bloemisterijgewassen en veredelingsteelt en bloemenzaadteelt, groentenzaadteelt en zaadteelt van fruitgewassen, kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemestersgewassen, voedergewassen en witlof, cichorei, boekweit en meekrap (onbedekte teelt) dient Quickdown verspoten te worden met een volume van L water /ha. In de vaste plantenteelt dient Quickdown verspoten te worden met een volume van L water /ha In de teelt van bessen en braam- en framboos-achtigen (Rubus spp.) wordt Quickdown toegepast tegen wortelopslag als deze niet groter dan 20 cm zijn. Om in het water levende organismen te beschermen is de toepassing in perceelsstroken die grenzen aan oppervlaktewater in de eerste 14 m vanaf de insteek van de sloot uitsluitend toegestaan indien gebruikt wordt gemaakt van minimaal 90% driftreducerende spuitdoppen. Om niet tot de doelsoorten behorende planten te beschermen is toepassing uitsluitend toegestaan wanneer in perceelsstroken die niet grenzen aan oppervlaktewater in de eerste 14 m van het gewas, gemeten vanaf het midden van de laatste gewasrij of de laatste plant in de rij gebruik wordt gemaakt van minimaal 50% driftreducerende spuitdoppen. De toepassing in asperge (onbedekte teelt) kan plaats vinden wanneer de bedden afgedekt zijn met plastic. Indien de toepassing tussen nietafgedekte bedden plaatsvindt, dient een afschermkap te worden gebruikt. Page 3

10 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT Contents 1 Identity of the plant protection product Packaging description Physical and chemical properties Methods of analysis Mammalian toxicology... 3 AOELsystemic: 20 x 0.56 x 70 / (7 x 3 x 3) = 12.4 mg/day Residues Environmental fate and behaviour Ecotoxicology Efficacy Conclusion Classification and labelling Identity of the plant protection product Packaging description Physical and chemical properties Methods of analysis Mammalian toxicology... 3 AOELsystemic: 20 x 0.56 x 70 / (7 x 3 x 3) = 12.4 mg/day Residues Environmental fate and behaviour Ecotoxicology Efficacy Conclusion Classification and labelling Quickdown, NLKUG 1

11 1 Identity of the plant protection product 1.1 Applicant Certis Europe B.V. Safariweg MA Maarssen The Netherlands 1.2 Identity of the active substance The identity of the active substance(s) does not change. Common name Name in Dutch Chemical name CAS no EC no Not allocated Pyraflufen-ethyl Pyraflufen-ethyl Ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4- fluorophenoxyacetate The active substance was included in Annex I of Directive 91/414/EEC on 1 November From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC. 1.3 Identity of the plant protection product The identity of the plant protection product does not change. Name Formulation type Content active substance Quickdown EC 26.5 g/l pure pyraflufen-ethyl The formulation was not part of the assessment of the active substance for inclusion in Annex I of Directive 91/414/EEC. 1.4 Function Herbicide 1.5 Uses applied for See GAP (Appendix I). 1.6 Background to the application It concerns a simplified extension of the authorization with minor uses. 1.7 Packaging details Packaging description Packaging details do not change. 2 Physical and chemical properties The physical and chemical properties of the active substance(s) and the formulation do not change. Quickdown, NLKUG 2

12 3 Methods of analysis 3.1 Analytical methods in technical material and plant protection product The analytical methods for the technical material and the plant protection product do not change. 3.2 Residue analytical methods The proposed extension for use involves application on crops that can be extrapolated from the current authorisation based on their crop group (matrix) and their MRL, with the exception of tree nuts. For tree nuts, the related analytical methods require an evaluation (see below). For the other applications, the proposed extension remains within the existing risk envelope for the section residue analytical methods for food/feed of plant and animal origin. The residue analytical methods for air, soil and water were accepted during the assessment which led to the original authorization of Quickdown. This simplified extension does not give rise to reassess these residue analytical methods. Evaluation residue analytical methods for tree nuts Tree nuts are matrices with a high fat content. The original authorization does not cover this matrix type. In the renewal dossier, appropriate residue analytical methods are included. The applicant has access to the data included in the renewal dossier. Data presented below is taken from the List of Endpoints included in the peer review conclusion of the substance renewal procedure, EFSA Journal 2015;13(2);4001. Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) DFG-S19 LC-MS/MS LOQ 0.01 mg/kg (pyraflufen-ethyl, pyraflufen (E-1)) Cucumber: module E1, wheat: module E2, orange: module E3, sunflower seed: Module E9. Not required. The residue definition for tree nuts is the sum of pyraflufen-ethyl and pyraflufen, expressed as pyraflufen. The required LOQ is 0.02 mg/kg. The residue analytical method is considered adequate to monitor residues in tree nuts at the default MRL of 0.02 mg/kg. 3.3 Conclusion With the exception of the use in tree nuts, the proposed extension for use is covered by the risk envelope of the existing authorisation for the section residue analytical methods. For tree nuts, adequate residue analytical methods are available to monitor the MRLs. 4 Mammalian toxicology List of Endpoints Pyraflufen-ethyl is a new active substance, included in Annex I of Directive 91/414/EEC. The final List of Endpoints presented below is taken from the final Review Report on pyraflufen-ethyl Quickdown, NLKUG 3

13 (SANCO/3039/99 final, d.d. 2 July 2002). Where relevant, some additional remarks/information are given in italics. Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1) Rate and extent of absorption: Distribution: Potential for accumulation: Rate and extent of excretion: Metabolism in animals Toxicologically significant compounds (animals, plants and environment) Rapid, dose-dependent; 56% (urine + bile) after low dose within 2 days. At 6 h, highest residues in GI tract, liver and excretory organs. No accumulation % in 24 h (70% via feces; 30% urinary) Ester hydrolysis; N-demethylation < 1% absorbed dose eliminated unchanged Parent compound, metabolites E1 and E9 Metabolism in plants and animals is similar. Acute toxicity (Annex IIA, point 5.2) Rat LD 50 oral Rat LD 50 dermal Rat LC 50 inhalation Skin irritation Eye irritation Skin sensitisation (test method used and result) > 5000 mg/kg bw > 2000 mg/kg bw > 5.3 mg/l Not-irritant Not-irritant Not sensitising (Maximisation test) Short term toxicity (Annex IIA, point 5.3) Target / critical effect Lowest relevant oral NOAEL / NOEL Lowest relevant dermal NOAEL / NOEL Lowest relevant inhalation NOAEL / NOEL Liver, kidney, red blood cells 200 ppm (20 mg/kg bw/d) 90 day mouse (satellite group in 78 wk study) No data, not necessary No data, not necessary Genotoxicity (Annex IIA, point 5.4) Not genotoxic 1 1 The substance was tested for in vitro gene mutations in an Ames test and two mouse lymphoma assays. Furthermore, an in vitro chromosome aberration test with human lymphocytes and an in vitro DNA repair assay are available. Regarding in vivo data, an UDS test (rat liver) and a micronucleus assay with mice are available. While no point mutations were observed in bacterial cells, positive results were obtained in mouse lymphoma cells in the presence of metabolic activation. As the forward mutation study showed a slight positive evidence in the presence of metabolic activation, it was required from the notifier to confirm these results in a new study. In a second test conducted using lymphoma cells a clear negative response was observed. Pyraflufen-ethyl was negative in the DNA repair test using the Bacillus subtilis rec assay as indicator, and did not cause DNA damage in rat liver in vivo. Pyraflufen-ethyl did not induce clastogenic or other damage in vivo in mice. In conclusion, pyraflufen-ethyl is not genotoxic. Long term toxicity and carcinogenicity (Annex IIA, point 5.5) Target/critical effect Lowest relevant NOAEL / NOEL Carcinogenicity Red blood cells and liver in mice, urinary and biliary tract in rats. 200 ppm (20 mg/kg bw/d ) 2 year mice study 400 ppm ( 20 mg/kg bw/d) 2 year rat study Increased incidence of hepatocellular adenomas in mice Quickdown, NLKUG 4

14 at hepatotoxic doses, not carcinogenic in rats. Classification and labelling not appropriate. Reproductive toxicity (Annex IIA, point 5.6) Target / critical effect - Reproduction Lowest relevant reproductive NOAEL / NOEL Target / critical effect - Developmental toxicity Lowest relevant developmental NOAEL / NOEL Reduced body weight gain of pups during lactation at parental toxic doses. NOAELsyst.tox = 1000 ppm (70.8 mg/kg bw/d) NOAELreprotox = 1000 ppm ( 70.8 mg/kg bw/d) Implantation loss and retardations in rabbits at maternally toxic doses (mortality). 20 mg/kg bw/d Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)... No data, not necessary Other toxicological studies (Annex IIA, point 5.8)... Accumulation of porphyrins in all organs except skin and Harderian glands. Inhibitor of some liver P450 dependent activities; inhibitor of catalase. Induction of liver single cell necrosis followed by mitosis. Medical data (Annex IIA, point 5.9)... No detrimental effects on health were found in participating personnel in manufacturing of pyraflufenethyl. Summary (Annex IIA, point 5.10) Value Study Safety factor ADI 0.2 mg/kg bw/d NOAEL from 2 year rat, mice study AOEL systemic AOEL inhalation AOEL dermal ARfD (acute reference dose) mg/kg bw/d Not necessary Not necessary 90 day satellite groups of 78 wk mouse carcinogenicity study 0.2 mg/kg bw/d Same basis as ADI and AOEL supported by rabbit teratogenesis study x 56% 100 Dermal absorption (Annex IIIA, point 7.3) No studies; dermal absorption not higher than oral absorption (56%). Local effects Pyraflufen-ethyl does not produce local effects after a single exposure. Regarding repeated dermal exposure, no data regarding the occurrence of local effects are available. Quickdown, NLKUG 5

15 Data requirements active substance No additional data requirements are identified. 4.1 Toxicity of the formulated product (IIIA 7.1) The formulation Quickdown does not need to be classified on the basis of its acute oral (LD 50 rat >2000 mg/kg bw), and dermal (LD 50 rat >2000 mg/kg bw) toxicology. It needs to be classified as H332 Harmful if inhaled, based on the inhalation toxicology (LC 50 rat: mg/l). The formulation Quickdown is considered irritating to skin and needs to be classified as R38 Irritating to skin / H315 Causes skin irritation. The formulation Quickdown is considered severely irritating to eyes and needs to be classified as R41 Risk of serious damage to eyes / H318 Causes serious eye damage. The formulation Quickdown does not have sensitising properties in a Buehler test, but is positive in a LLNA test for skin sensitisation and therefore needs to be classified as R43 May cause sensitisation by skin contact /H317 May cause an allergic skin reaction Data requirements formulated product No additional data requirements are identified. 4.2 Dermal absorption (IIIA 7.3) See List of Endpoints. In the DAR no dermal absorption studies are available. For the current application also no dermal absorption studies are provided. Therefore, the value of 56% will be used for the current risk assessment for dermal absorption of the concentrate and the spray dilution. 4.3 Available toxicological data relating to non-active substances (IIIA 7.4) The available toxicological data relating to non-active substances will be taken into account in the classification and labelling of the formulated product. 4.4 Exposure/risk assessments Overview of the intended uses An application has been submitted for an extension of the authorisation of the plant protection product, a herbicide based on the active substance pyraflufen-ethyl. is an EC (emulsifiable concentrate) formulation and contains 26.5 g/l pyraflufen-ethyl 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 pyraflufen-ethyl no TLV has been set. The AOEL will be used for the risk assessment. Since the formulation is applied once during period March - June, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived. Quickdown, NLKUG 6

16 Pyraflufen-ethyl is included in Annex I of 91/414/EEC and approved under Regulation (EC) No 1107/2009, therefore the semi-chronic EU-AOEL of mg/kg bw/day (= 7.84 mg/day for a 70-kg operator), based on the 90-day satellite groups of a 78-week mouse carcinogenicity study, is used for the risk assessment (see List of Endpoints). Exposure/risk Exposure to pyraflufen-ethyl during mixing and loading and application of 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. In the Table below the estimated internal exposure is compared with the systemic EU-AOEL. Table T.1 Internal operator exposure to pyraflufen-ethyl and risk assessment for the use of Quickdown Route Estimated internal exposure a (mg /day) Systemic EU-AOEL (mg/day) Risk-index b Manual downward on crops applied for (uncovered, kg a.s./ha) Mixing/ Respiratory < <0.01 Loading c Dermal Application d Respiratory Dermal Total a Internal exposure was calculated with: biological availability via the dermal route: 56% (concentrate and spray dilution) (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. c External exposure is estimated with EUROPOEM (dermal) and NL-model (inhlation). d External exposure is estimated with UK POEM. Since the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL. Tier 2 Calculation of the NL-AOEL The risk index calculated with the EU-AOEL is >1. Therefore, the Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL based on allometric extrapolation (known as the NL-AOEL). This method takes into account the caloric demand of the species studied and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied. The calculation of the systemic AOEL for semi-chronic exposure is based on the NOAEL of 20 mg/kg bw/day in 90-day satellite groups of a 78-week mouse carcinogenicity study. Calculations from other studies result in higher AOELs. Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur. Used factors are: Quickdown, NLKUG 7

17 extrapolation Tekst human on basis of caloric demand 7 other interspecies differences: 3 intraspecies differences: (professional use) 3 biological availability via oral route: 56%* weight of professional operator/worker: 70 kg * If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption. AOELsystemic: 20 x 0.56 x 70 / (7 x 3 x 3) = 12.4 mg/day Exposure/risk Table T.2 Internal operator exposure pyraflufen-ethyl and risk assessment for the use of Quickdown Route Estimated internal exposure a (mg /day) Systemic NL-AOEL (mg/day) Risk-index b Manual downward on crops applied for (uncovered, kg a.s./ha) Mixing/ Respiratory < <0.01 Loading c Dermal Application d Respiratory <0.01 Dermal Total a Internal exposure was calculated with: * biological availability via the dermal route: 56% (concentrate and spray dilution) (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. c External exposure is estimated with EUROPOEM (dermal) and NL-model (inhlation). d External exposure is estimated with UK POEM. Since the NL-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required Bystander exposure/risk The water volume is lower in the newly applied for uses, and therefore the risk for bystanders will be higher. However, considering the risk index calculated for the existing uses (RI<0.01) no risk is anticipated for the bystander with the applied for uses Worker exposure/risk Considered to be within the risk envelope of the existing uses Re-entry See 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 puraflufen-ethyl as a result of the application of Quickdown in the uses applied for. Quickdown, NLKUG 8

18 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 puraflufen-ethyl as a result of the application of Quickdown in the uses applied for. Worker exposure Shortly after application it is not necessary to perform any re-entry activities including crop inspection tasks. Therefore no adverse health effects to workers are expected. 4.5 Appropriate mammalian toxicology and operator exposure end-points relating to the product and approved uses See List of Endpoints. 4.6 Data requirements Based on this evaluation, no additional data requirements are identified. 4.7 Combination toxicology Quickdown contains only one active substance and it is not described that it should be used in combination with other formulations. 5 Residues The List of Endpoints presented below is taken from Peer Review of the pesticide risk assessment of the active substance pyraflufen-ethyl (EFSA Journal 2015;13(2):4001). Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered Rotational crops Metabolism in rotational crops similar to metabolism in primary crops? Foliar: wheat (cereals), potato (root and tuber crops) and cotton (pulses and oilseeds) Soil: citrus (fruit crops) Root and tuber vegetables (radish), leafy vegetables (lettuce) and cereals (barley) at 0.33 N rate at 30 and 120/150 day plant back intervals. Yes Processed commodities Residue pattern in processed commodities similar to residue pattern in raw commodities? Not applicable, not required Not applicable Plant residue definition for monitoring Plant residue definition for risk assessment Conversion factor (monitoring to risk assessment) Sum of pyraflufen-ethyl and pyraflufen (E-1), expressed as pyraflufen-ethyl. Sum of pyraflufen-ethyl and pyraflufen (E-1), expressed as pyraflufen-ethyl. Not applicable Quickdown, NLKUG 9

19 Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Conversion factor (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) Lactating goat, laying hen Eggs: unknown Milk: 3 days Not required. Not required. None yes Non fat-soluble Although Log P ow = 3.49 at ph 7, TRR recovered at a trace level in fat and fat free muscle (< mg/kg). Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5) Field rotational crop trials in lettuce, spring barley, sugar beet, cabbage and maize after a bare soil treatment at 42.4 g a.s./ha with plant back intervals of 6 and 30 days. Residues of pyraflufen-ethyl and E-1 <LOQ in all edible parts of the following crops at all sampling intervals. Significant residue levels of the high persistent E-3 metabolite are not expected in rotational crops since the field trials were conducted at a rate covering the calculated plateau concentration of E-3 in soil. Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction) Plant matrices: Residues of pyraflufen-ethyl and pyraflufen E-1 are stable under frozen conditions (<-18 C) for at least: -10 months in high water content matrices (potato tubers); -12 months in high acid content matrices (grapes); -12 months in wheat grain and 18 months in wheat straw and shoot for pyraflufen-ethyl; -18 months in wheat grain, straw and shoot for pyraflufen E-1. Animal matrices: Residues of pyraflufen-ethyl and pyraflufen E-1 Quickdown, NLKUG 10

20 are stable under frozen conditions (<-18 C) for at least: -3 months in milk, -2.5 months in muscle and fat, -2 months in liver and kidney for pyraflufen E-1 whilst pyraflufen-ethyl was not stable in these matrices over the 2 months of storage. Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Ruminant: Poultry: Pig: Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no - If yes, specify the level) Potential for accumulation (yes/no): Conditions of requirement of feeding studies no no no no no no Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) no no no Since feeding studies are not triggered with respect to the calculated dietary burden, the ruminant feeding study reported in the DRAR was not peer reviewed. Muscle Liver Kidney Fat Milk - Eggs - Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/ process/ processed product Number of studies Processing factors Mean transfer Factor (range) No studies required, not performed Yield factor Amount transferred (%) (Optional) Comments on/additions to List of Endpoints No comments Quickdown, NLKUG 11

21 5.1 Summary of residue data The following assessment is based on Renewal Assessment Report (RAR, the Netherlands, December 2013), peer review of active substance pyraflufen-ethyl (EFSA Journal 2015;13(2):4001); Article 12 MRL review (EFSA Journal 2013; 11(3):3142) and Evaluation Report, Ctgb, November Metabolism in plants In the peer review (EFSA Journal 2015;13(2):4001) metabolism in plants was investigated as foliar application in wheat (cereals), potato (root and tuber vegetables) and cotton (pulses and oilseeds). As a soil application metabolism was investigated in mandarin (fruit crops). Following foliar and soils applications, very low levels of radioactive residues (<0.001 mg/kg) were recovered in all the edible parts of the crops. Therefore, metabolites identification was not further investigated in cotton seed, wheat grain and mandarin fruit. Parent compound was not detected in any crop parts, whilst metabolites E-1, E-2 and E-3 were or not detected or recovered in very low amounts. Metabolite E-1 was also shown to be a valid marker of residues, particularly in cereal straw Metabolism in livestock Requested crops are not part of animal food or feed, therefore, possible assessment of residues in animals is not required Residue definition (plant and animal) Plant residue definitions for risk assessment and monitoring are : sum of pyraflufen-ethyl and pyraflufen, expressed as pyraflufen-ethyl. No animal residue definitions in animals are required for this application Stability of residues Residues of pyraflufen-ethyl and pyraflufen (E-1) are stable 10 months in high water matrices (potato tubers) and 12 months in high acid matrices (grapes) Supervised residue trials Stone fruit (cgap-nl:2x21.2 g as/ha, interval 21 days, Pre-flowering: BBCH and post-harvest BBCH>91) Tree nuts (cgap-nl: 2x 21.2 g as/ha, interval 21 days, Pre-flowering BBCH 00-61, post-harvest BBCH>91) No trials with pyraflufen-ethyl in stone fruits and tree nuts are available for this application. However, according to document SANCO 7525/VI/95 rev.9, for use early in the growing season, when no edible parts of crop are present, extrapolation to stone fruit and tree nuts is possible from four trials in apples and either citrus fruit or stone fruit. Four trials with pyraflufen-ethyl in apples are available for this application. The trials have been evaluated by Ctgb ( Evaluation Report, 2015). In two trials adjuvant Toil was used. Application rate and intervals were according to cgap. The last application was done at BBCH Residues of pyraflufen ethyl and metabolite E-1, measured in apple fruits, at harvest, were in all trials below the LOQ (0.01 mg/kg). Four available trials in apples are considered sufficient to demonstrate that after use of the product Quickdown, containing pyraflufen-ethyl, in stone fruits and tree nuts a zero-residue situation will apply. This conclusion is in line with the MRL review of pyraflufen-ethyl (EFSA Journal 2013; 11(3):3142) where, it was concluded that based on metabolism study in mandarins and data on rotational crops, no residues exceeding the enforcement LOQ of 0.01 mg/kg are expected. In the MRL review two trials on apples in Southern Europe were sufficient to support use of pyraflufen ethyl in stone fruits and tree nuts, also in Northern Europe. For this application, no additional data are required. Quickdown, NLKUG 12

22 The current EU-MRL of pyraflufen-ethyl in stone fruit and tree nuts is 0.02* mg/kg and the requested uses are covered by the available trials in apples. Grapes (cgap-nl: 2x 21.2 g as/ha, interval 21 days, Pre-flowering BBCH 00-61, post-harvest BBCH>91) Four residue trials with pyraflufen-ethyl in grapes in Northern Europe are available for this application. Two trials were evaluated in the RAR (the Netherlands, December 2014). Two trials were evaluated by Ctgb ( Evaluation Report). All the trials have been performed according to the proposed cgap. Grapes were collected at harvest. In all four trials residues were below the LOQ of 0.01 mg/kg, which is sufficient to demonstrate the zero-residue situation. No additional data is required. The current EU-MRL of pyraflufen-ethyl is 0.02* mg/kg and the requested use is covered by the available trials. Strawberry Berries Blackberries and raspberry family (cgap-nl: 2x 21.2 g as/ha, interval 21 days, Pre-flowering BBCH 00-61, post-harvest BBCH>91) No trials with berries and small fruits are available for this application. However, according to document SANCO 7525/VI/95 rev.9, extrapolation early in the growing season, to the whole group of berries and small fruit is possible from 4 trials on strawberries and 4 trials on either grapes, blackcurrants or other berries. For this application four trials in grapes (see above) are considered sufficient to demonstrate that after use of the product Quickdown in strawberry, berry, blackberry and raspberry family, a zeroresidue situation will apply. This conclusion is in line with the MRL review of pyraflufen-ethyl (EFSA Journal 2012; 11(3):3142) where, it was concluded that based on metabolism study in mandarins and data on rotational crops no residues exceeding the enforcement LOQ of 0.01 mg/kg are expected in those crops. In the MRL review two trials on apples in Southern Europe were sufficient to support use of pyraflufen-ethyl in grapes, currants, gooseberries and elderberries, also in Northern Europe. No additional data are required for this application. The current EU-MRL of pyraflufen-ethyl in strawberry, berries, blackberry and raspberry family is 0.02* mg/kg and the requested uses are covered by the available trials in grapes. Kiwi (cgap-nl: 2x 21.2 g as/ha, interval 21 days, Pre-flowering BBCH 00-61, post-harvest BBCH>91) Four residue trials in kiwi in Southern Europe were submitted for this application. The trials were evaluated by Ctgb ( Evaluation Report, 2015). In all the trials samples were treated with a formulation with and without adjuvant (Toil). The trials were performed with the application rate and interval, according to the proposed cgap. The last application was done at BBCH In all the trials residues in kiwi fruits at harvest were below the LOQ of 0.01 mg/kg. In Northern Europe kiwi is a very minor crop. Four trials are required. However, based on the available trials in Southern Europe a zero-residue situation is clearly demonstrated. Moreover, it was concluded by EFSA in MRL review of pyraflufen-ethyl, that based on metabolism in citrus fruit studies and rotational crops studies, residues above the LOQ of 0.01 mg/kg are not expected. Therefore, for this application, no additional data is required. The current EU-MRL of pyraflufen-ethyl in kiwi is 0.02* mg/kg and the requested use is covered by the available trials. Asparagus (cgap-nl: 2x 21.2 g as/ha, interval 21 days, Pre-flowering BBCH 00-61, post-harvest BBCH>91) Quickdown, NLKUG 13

23 No trials in asparagus were submitted for this application. The application is proposed before flowering and post-harvest,therefore when no edible crop parts are present. In the peer review and MRL review of pyraflufen-ethyl it was concluded that based on metabolism study in primary and rotational crops no residues above the LOQ are expected. Therefore, based on this information it could be concluded that residues in asparagus at harvest are not expected above the LOQ (0.01 mg/kg), when the product is used according the proposed cgap Residues in succeeding crops It was concluded in the peer review and MRL review that no significant residues of pyraflufen-ethyl and its metabolites are expected in rotational crops Residues from livestock feeding studies Requested crops are not part of animal food or feed, therefore, possible assessment of residues in animals is not required Processing factors In all investigated crops residues were below the LOQ of 0.01 mg/kg. Residues in processed commodities are, therefore, not required. Moreover, TMDI did not exceed 10%, which supports the conclusion, that no additional processing data are required Calculation of the ADI and the ARfD Calculation of the ADI The ADI is based on the NOAEL of 20 mg/kg bw/d in the 2-year rat and 18 months mouse study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.2 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-d oral mouse and rabbit development. study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD of 0.2 mg/kg bw/day (see the List of Endpoints for mammalian toxicology). 5.2 Maximum Residue Levels Harmonised EU-MRLs are present in Annex II of Regulation (EC) 396/2005. The product complies with the MRL Regulation. 5.3 Consumer risk assessment Input values The following input values were used for the consumer risk assessment. Table R2: Input values for the consumer risk assessment Crop Chronic risk assessment Acute risk assessment Input value (mg/kg) Comment Input value (mg/kg) Comment Stone fruits 0.02 STMR 0.02 HR Tree nuts 0.02 STMR 0.02 HR Grapes 0.02 STMR 0.02 HR Strawberry 0.02 STMR 0.02 HR Berries 0.02 STMR 0.02 HR Blackberry and raspberry family 0.02 STMR 0.02 HR Kiwi 0.02 STMR 0.02 HR Quickdown, NLKUG 14

24 Crop Chronic risk assessment Acute risk assessment Input value (mg/kg) Comment Input value (mg/kg) Comment Asparagus 0.02* MRL 0.02* MRL Other crops Current EU-MRL (Reg. (EU) No 703/2014 Acute risk assessment was only calculated for the requested crops 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. The maximum TMDI is 0.8% of the ADI for French toddler. The TMDI is 0.2% and 0.7% 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 The highest percentage of the ESTI is 0.7 % of the ARfD for table grapes for the German adults diet. ESTI values for the other commodities in all other consumer diets are all lower. Conclusion Based on the assessment for residues, no risk for the consumer due to the exposure to pyraflufenethyl is currently expected. The product complies with the Uniform Principles. 5.4 Data requirements No data requirements were identified. 6 Environmental fate and behaviour Risk assessment is done in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011). For the risk assessment the LoEP of the Review report is used (SANCO/3039/99-FINAL, 2 july 2002). Some additional information is added in Italics. For the current risk assessment, the previous risk assessment and the data submitted for the Quickdown (13246N) were used. List of Endpoints Fate/behaviour pyraflufen-ethyl (SANCO/3039/99-FINAL, 2 july 2002) Fate and behaviour in soil Route of degradation Aerobic: Mineralization after 100 days: 2.53% Non-extractable residues after 100 days: 17% Relevant metabolites above 10 % of applied active substance: name and/or code % of applied rate (range and maximum) E-1* (max 94% at d 1), E-2* (max 14-19%), E-3* (max 56-69%), Structure of unknown2 (10%) is rather similar to the a.s. and the 3 main metabolites. Quickdown, NLKUG 15

25 * E-1 = pyraflufen-acid; E-2 = me-2: hydroxy - pyraflufen; E-3 = methoxy -pyraflufen Supplemental studies Anaerobic: E-1 major degradation product (max 99%) E-2 (max 28%) 2.04% bound residue 0.2% mineralization Soil photolysis: Remarks: Rate of degradation Laboratory studies DT50lab (20 C, aerobic): DT90lab (20 C, aerobic): DT50lab (10 C, aerobic): DT50lab (20 C, anaerobic): No photodegradation : DT50 = 299 d None a.s.: < 0.5 d (4 values) E-1: d (4 values) E-2: 6-11 d (3 values) E-3: d (3 values) a.s.: d (4 values) E-1: d (4 values) E-2: d (3 values) E-3: d (3 values) a.s.: 1 d (1 value) E-1: 328 d (1 value) a.s.: 1 d (1 value) E-1: 191 d (1 value) E-2: 392 d (1 value) Field studies (country or region) DT50f from soil dissipation studies: DT90f from soil dissipation studies: Soil accumulation studies: Soil residue studies: Remarks: e.g. effect of soil ph on degradation rate Adsorption/desorption Kf / Koc: Kd a.s., spring: 1-7 d (4 sites in FR, UK, DE) a.s., fall: 1-3 d (4 sites in FR, UK, DE) E-1, spring: d (4 sites in FR, UK, DE) E-1, fall: d (4 sites in FR, UK, DE) a.s., spring: 3-23 d (4 sites in FR, UK, DE) a.s., fall: 3-10 d (4 sites in FR, UK, DE) E-1, spring: d (4 sites in Fr, UK, DE) E-1, fall: d (4 sites in Fr, UK, DE) Max level E-2: 0.01 mg /kg soil Max level E-3: mg /kg soil Not required Not required None Koc (a.s., HPLC) = 1949 Kf (E-1, 3 soils) = ; Koc = Kf (E-2, 3 soils) = ; Koc = Quickdown, NLKUG 16

26 ph dependence: Mobility Laboratory studies: Column leaching: Aged residue leaching: Field studies: Lysimeter/Field leaching studies: Remarks: Kf (E-3, 3 soils) = ; Koc = No 0.2 % RR in the leachate 0.5 % RR in the leachate Not required None Fate and behaviour in water Abiotic degradation Hydrolytic degradation: Relevant metabolites: Photolytic degradation: Relevant metabolites: E-1, E-2 a.s. (ph 7, 25 C): 13.1 d a.s. hydrolytically stable at ph 4, rapidly hydrolyzed at ph 9. The only hydrolysis product E-1 is stable at ph a.s. (20 C): 30 h (major degradate : PD1) E-1 (25 C): 22.1 h E-2 (25 C): 8.7 h E-3 (25 C): 29.1 h Biological degradation Readily biodegradable: Water/sediment study: DT50 water: DT90 water: DT50 whole system: DT90 whole system: Distribution in water / sediment systems (active substance) Distribution in water / sediment systems (metabolites) Accumulation in water and/or sediment: Degradation in the saturated zone Remarks: No a.s.: 1-2 h, E-1 = d, a.s.: 4-7 h a.s.: 2-2h a.s.: 6-7 h a.s. mainly in water phase E-1: mainly in water phase (83-94% after 1 d, 11-42% after 100 d) E-2: mainly in sediment phase (20-54% after 100 d) E-3: mainly in sediment phase (6-7% after 100 d) No Not required None Quickdown, NLKUG 17

27 Fate and behaviour in air Volatility Vapour pressure: Henry's law constant: Photolytic degradation Direct photolysis in air: Photochemical oxidative degradation in air DT50: Volatilisation: Remarks: Pa (25 C) Pa (20 C) Pa.m3/mol (20 C) DT50 : 11.3 h Latitude: 52 N Season: June DT50 : 33 h No volatilisation from plant surfaces or soil. None Appendix A: Metabolite names, codes and other relevant information of the plant protection product Quickdown with active substance pyraflufen-ethyl. The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of active substance pyraflufen-ethyl. The parent compound structure of pyraflufen-ethyl is shown first in this list and followed by degradates or related compounds. Compoun d name / Code number(s ) Pyraflufe n-ethyl IUPAC name Ethyl 2-chloro-5- (4-chloro-5- difluoromethoxy-1- methylpyrazol-3- yl)-4- fluorophenoxyacet ate Structural formula C 15 H 13 Cl 2 F 3 N 2 O 4 Structure Cl F N N Cl OCHF 2 Molecul ar Weight [g/mol] Observed in study (% of occurrenc e/ formation ) OCH 2 COOC 2 H Parent substanc e CH 3 Pyraflufe n-acid/ E-1 C 13 H 9 Cl 2 F 3 N 2 O 4 Cl HOOCCH 2 O F N Cl N CH 3 OCH Soil: 94% Water: 94% hydroxy - pyraflufe n/ E-2 C 11 H 7 Cl 2 F 3 N 2 O 2 Cl HO E-1 F Cl OCHF 2 N N CH Soil: 19% Water: 54% Quickdown, NLKUG 18