HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 BESLUIT
Op 13 april 2011 is van
BELCHIM Crop Protection nv/sa Technologielaan 7
B-1840 LONDERZEEL BELGIE
een aanvraag tot herregistratie van de toelating ontvangen voor het gewasbeschermingsmiddel Symphonie
op basis van de werkzame stof flutolanil.
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit.
Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen:
- Bijlage I voor details van de aanvraag en toelating.
- Bijlage II voor de etikettering.
- Bijlage III voor wettelijk gebruik.
- Bijlage IV voor de onderbouwing.
1.1 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.
1.2 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven.
1.3 Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld:
- De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder
“verpakkingsinformatie” in bijlage I bij dit besluit.
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 onder A in bijlage III bij dit besluit.
- Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
1.4 Aflever- en opgebruiktermijn (respijtperiode)
Bij de herregistratie wordt het etiket uitgebreid met de toepassing in de teelt van pootaardappel.
Tevens vervalt de restrictie op het gebruik in grondwaterbeschermingsgebieden. Dit betekent dat het etiket uitgebreid wordt bij herregistratie. Daarom wordt de W-codering verhoogd naar W.1; een respijtperiode is niet van toepassing voor het afleveren en opgebruiken van bestaande voorraden met het huidige etiket zonder W-codering (W.0).
Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht.
2 WETTELIJKE GRONDSLAG
Besluit artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden
Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader RGB (Hoofdstuk 2) en de Evaluation Manual 1.1.
3 BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en
ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar
geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.
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, 6 november 2015
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw Voorzitter
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie
Aanvraagnummer: 20110407 THG
Type aanvraag: aanvraag tot herregistratie van de toelating van het gewasbeschermingsmiddel
Middelnaam: Symphonie
Formele registratiedatum: * 31 mei 2011 Datum in behandeling name: 29 juli 2012 Datum compliance check: 28 augustus 2009
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2 Stofinformatie
Werkzame stof Gehalte
flutolanil 60G/KG
De stof flutolanil is per 1 maart 2009 geplaatst op Annex I van Richtlijn 91/414/EEG (Dir 2008/108/EC d.d. 26 november 2008) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof expireert op 28 februari 2019.
3 Toelatingsinformatie
Toelatingsnummer: 13148 N
Expiratiedatum: 1 november 2025
Afgeleide of parallel: n.v.t.
Biocide, gewasbeschermingsmiddel of toevoegingsstof:
Gewasbeschermingsmiddel
Gebruikers: Professioneel
W-codering professioneel gebruik: W.1 4 Aflever- en opgebruiktermijnen voor oude etiket
Vorige W-codering professioneel gebruik: W.0 Aflevertermijn professioneel gebruik: N.v.t.
Opgebruiktermijn professioneel gebruik: N.v.t.
5 Verpakkingsinformatie
Aard van het preparaat: Stuifpoeder
BIJLAGE II Etikettering van het middel Symphonie Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
Flutolanil
Pictogram GHS07
Signaalwoord WAARSCHUWING
Gevarenaanduidingen H319 Veroorzaakt ernstige oogirritatie.
H412 Schadelijk voor in het water levende organismen, met langdurige gevolgen.
Voorzorgsmaatregelen P273 Voorkom lozing in het milieu.
P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen.
P337 + P313 Bij aanhoudende oogirritatie: een arts raadplegen.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
Aanvullende etiketelementen
EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.
Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee
BIJLAGE III WGGA van het middel
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als schimmelbestrijdingsmiddel door middel van een pootgoedbehandeling in de teelt van:
a) poot-, consumptie- en zetmeelaardappel.
Bij de interpretatie van wat valt onder bovengenoemde teelten is uitgegaan van de definitielijst toepassingsgebieden gewasbeschermingsmiddelen, versie 2.0, Ctgb juni 2011.
Toepassing mag uitsluitend plaatsvinden door middel van een pootgoedbehandeling.
Dit middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Pootaardappel, consumptieaardappel en zetmeelaardappel, pootgoedbehandeling ter bestrijding van lakschurft (Rhizoctonia solani).
Dosering: 150 gram middel per 100 kg pootgoed
De toepassing kan of geheel automatisch plaatsvinden met een op de pootmachine opgebouwd poeder-doseerapparaat dan wel handmatig. Bij de laatste methode wordt per voorraadbak met 50 kg aardappelen 75 gram middel zo gelijkmatig mogelijk over het pootgoed uitgestrooid; bij voorkeur met behulp van een bus of maatbeker waarop het volume van 75 gram poeder met een merkstreep is aangegeven. De knollen worden door de pootketting in beroering gebracht zodat een herverdeling van het middel tot stand komt en de aardappelen rondom worden bepoederd. Om te voorkomen dat bij de start onbepoederde knollen de grond ingaan moeten er een aantal van tevoren bepoederde knollen onderin de voorraadbak van de pootmachine worden gedaan.
Indien tijdens regen wordt gepoot het middel alleen toepassen met afgedekte voorraadbakken.
Indien aardappelen en poeder vochtig worden geeft dit aanleiding tot onregelmatige verdeling van het poeder over de knollen en is er kans op dichtsmeren van de ogen. Dit kan een vertraagde, onregelmatige opkomst tot gevolg hebben.
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV
RISKMANAGEMENT
Contents
Page
1. Identity of the plant protection product ... 2
2. Physical and chemical properties ... 3
3. Methods of analysis ... 7
4. Mammalian toxicology ... 9
5. Residues ... 14
6. Environmental fate and behaviour ... 18
7. Ecotoxicology ... 31
8. Efficacy ... 46
9. Conclusion ... 52
10. Classification and labelling ... 52
1. Identity of the plant protection product 1.1 Applicant
BELCHIM Crop Protection nv/sa Technologielaan 7
B-1840 LONDERZEEL Belgium
1.2 Identity of the active substance Common name Flutolanil
Name in Dutch Flutolanil
Chemical name α,α,α-trifluoro-3’-isopropoxy-o-toluanilide [IUPAC]
CAS no 66332-96-5
EC no Not allocated
The active substance was included in Annex I of Directive 91/414/EEC on 1 March 2009.
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
Name Symphonie
Formulation type Dustable powder (DP) Content active substance 60 g/kg pure flutolanil
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 Fungicide.
1.5 Uses applied for See GAP (Appendix I).
1.6 Background to the application
It concerns a re-registration of the existing uses of plant protection product Symphonie in ware and starch potatoes, and an extension with the use in seed potatoes.
1.7 Packaging details 1.7.1 Packaging description
Material: Paper/PE/Aluminium/PE (outside to inside)
Capacity: 2.5 kg
Type of closure and size of opening:
Folded
Other information ADR compliant (not applicable due to packaging size) 1.7.2 Detailed instructions for safe disposal
No particular recommendations.
2. Physical and chemical properties 2.1 Active substance: flutolanil
Data on the identity and the physical and chemical properties is taken from the List of Endpoints (LoEP). The final List of Endpoints presented below is taken from the EFSA Scientific report on flutolanil (2008) 126; 1-63 (d.d. 3 March 2008), also taking into account the final review report on flutolanil (SANCO/116/08 –rev. 1, d.d. 16 May 2008). Where relevant, some additional remarks/information are given in italics.
Identity
Active substance (ISO Common Name)
Flutolanil
Chemical name (IUPAC) α,α,α-trifluoro-3’-isopropoxy-o-toluanilide
Chemical name (CA) N-[3-(1-methylethoxy)phenyl]-2-(trifluoromethyl) benzamide
CIPAC No 524
CAS No 66332-96-5
EEC No (EINECS or ELINCS) Not allocated FAO Specification (including year of publication)
No FAO Specification available at the time of evaluation
Minimum purity of the active substance as manufactured (g/kg)
975 g/kg
Identity of relevant impurities (of toxicological, environmental and/or other significance) in the active substance as manufactured (g/kg)
none
Molecular formula C17H16F3NO2
Molecular mass 323.3 g/mol
Structural formula
Physical-chemical properties
Melting point (state purity) 103.9 to 105.2 °C (99.8 % )
Boiling point (state purity) Boiling start at 300 °C and is accompanied by decomposition. (99.8 % )
Temperature of decomposition Boiling start at 300 °C and is accompanied by decomposition. (99.8 % )
Appearance (state purity) White powder (99.8 %) Relative density (state purity) 1.321 at 20 oC (99.8%)
Surface tension 71.3 mN/m at 20 °C (90 % saturated solution) (99.8
%) Vapour pressure (in Pa, state
temperature)
4.1 · 10-7 Pa at 20 °C (99.8 %) 1.0 · 10-6 Pa at 25 °C (99.8 %) Henry’s law constant (in Pa·m3·mol-1) 1.65 · 10-5 Pa · m3 · mole-1
CONH
CF3 OCH(CH3)2
Solubility in water (in g/l or mg/l, state temperature)
8.01 mg/l at 20 °C (99.0 %) Solubility in organic solvents (in g/l or
mg/l, state temperature)
Solubility at 20 °C in g/l (99.3 %)
Acetone: 606
Acetonitrile: 334 Dichloromethane: 378 Ethyl acetate: 365
n-Hexane: 0.39
Methanol: 322
n-Octanol: 42
Toluene: 35
Partition co-efficient (log Pow) (state pH and temperature)
log PO/W = 3.17 at 21 °C (unbuffered solution) (100
%) Hydrolytic stability (DT50) (state pH
and temperature)
Not subject to hydrolysis at pH 5, 7 or 9 Dissociation constant Structure of flutolanil has no acidic or basic
substituents which could dissociate.
UV/VIS absorption (max.) (if absorption >290 nm state
ε
at wavelength)Neutral solution:
λmax = 208.5 nm ε = 11709 l · mol-1 · cm-1 λmax = 292.0 nm ε = 33109 l · mol-1 · cm-1 (99.8
%) Photostability (DT50) (aqueous,
sunlight, state pH)
Not subject to photolysis Quantum yield of direct photo-
transformation in water at λ > 290 nm
Not applicable (no photolysis) Photochemical oxidative degradation
in air
DT50 = 0.072 days (12 hour day at 25 oC). Hydroxyl radical concentration not reported in the DAR.
Flammability Not flammable (99.3 %)
Auto-flammability No self-ignition up to the melting point (99.3%) Oxidising properties Not oxidising (99.3 %)
Explosive properties Not explosive (99.3 %) 2.2 Plant protection product: Symphonie
Data on the plant protection product is taken from the studies reports submitted by the applicant. The plant protection product is to be used undiluted.
Section (Annex point)
Study Guidelines and GLP
Findings Evaluation and
conclusion B.2.2.1
(IIIA 2.1)
Appearance:
physical state
GLP: Y Method:
visual
Powder Acceptable
B.2.2.2 (IIIA 2.1)
Appearance:
colour
GLP: Y Method:
visual
White Acceptable
B.2.2.3 (IIIA 2.1)
Appearance:
odour
GLP: Y Method:
organoleptic
Odourless Acceptable
B.2.2.4 (IIIA 2.2)
Explosive properties
GLP: Y EEC A.14
Not explosive Acceptable
B.2.2.5 Oxidising GLP :Y Not oxidizing Acceptable
Section (Annex point)
Study Guidelines and GLP
Findings Evaluation and
conclusion B.2.2.6
(IIIA 2.3)
Flammability GLP :Y EEC A.10
Not highly flammable Acceptable
B.2.2.7 (IIIA 2.3)
Auto-
flammability
GLP:Y Modified Bowes-Cameron test; not self-heating
Acceptable
B.2.2.8 (IIIA 2.3)
Flash point Not applicable Acceptable
B.2.2.9 (IIIA 2.4)
Acidity / alkalinity
Not applicable Acceptable
B.2.2.10 (IIIA 2.4)
pH GLP:Y
CIPAC 75.3
1% solution: 8.97 Acceptable
B.2.2.11 (IIIA 2.5)
Surface tension
Not applicable Acceptable
B.2.2.12 (IIIA 2.5)
Viscosity Not applicable Acceptable
B.2.2.13 (IIIA 2.6)
Relative density
Not applicable Acceptable
B.2.2.14 (IIIA 2.6)
Bulk (tap) density
GLP:Y CIPAC MT 33
tap density: 0.573 g/L Acceptable
B.2.2.15 (IIIA 2.7)
Storage stability
GLP:Y Two weeks at 54° C in PE.
Tested properties: a.s.
content, wet sieve, pH Low temperature study is not applicable.
Acceptable.
No dry sieve test is performed, a wet sieve was
performed instead.
The results can be extrapolated to the commercial
packaging as PE can be seen as a worst case type of packaging.
B.2.2.16 (IIIA 2.7)
Shelf life GLP:Y Two years storage at ambient temperature in
Paper/PE/Alu/PE packaging.
Tested properties: a.s.
content, appearance, pH, particle size distribution.
Acceptable.
No dry sieve test is performed,
however the particle size distribution shows there is no
significant contribution of particles > 75 µm.
Section (Annex point)
Study Guidelines and GLP
Findings Evaluation and
conclusion B.2.2.17
(IIIA 2.8)
Wettability Not applicable Acceptable
B.2.2.18 (IIIA 2.8)
Persistent foaming
Not applicable Acceptable
B.2.2.19 (IIIA 2.8)
Suspensibility Not applicable Acceptable
B.2.2.20 (IIIA 2.8)
Spontaneity of dispersion
Not applicable Acceptable
B.2.2.21 (IIIA 2.8)
Dilution stability
Not applicable Acceptable
B.2.2.22 (IIIA 2.8)
Dry sieve test GLP:Y Malvern laser
particle size test
>95% less than 75 µm. Acceptable.
The Malvern laser test is a valid alternative to estimate a minimum particle size.
B.2.2.23 (IIIA 2.8)
Wet sieve test Not applicable Acceptable
B.2.2.24 (IIIA 2.8)
Particle size distribution
GLP:Y CIPAC MT 187
Normal distribution, >90%
smaller than 15,77 micron.
Acceptable
B.2.2.25 (IIIA 2.8)
Content of dust/fines
GLP:Y CIPAC MT 187
D90%: 15.77 µm D50%: 5.45 µm D10%: 1.55 µm
Acceptable
B.2.2.26 (IIIA 2.8)
Attrition and friability
Not applicable Acceptable
B.2.2.27 (IIIA 2.8)
Emulsifiability, re-
emulsifiability and emulsion stability
Not applicable Acceptable
B.2.2.28 (IIIA 2.8)
Stability of dilute emulsion
Not applicable Acceptable
B.2.2.29 (IIIA 2.8)
Flowability Not applicable Acceptable
B.2.2.30 (IIIA 2.8)
Pourability (rinsibility)
Not applicable Acceptable
Section (Annex point)
Study Guidelines and GLP
Findings Evaluation and
conclusion B.2.2.31
(IIIA 2.8)
Dustability GLP:Y CIPAC MT 34
Non dusty. Acceptable
B.2.2.32 (IIIA 2.8)
Adherence and
distribution to seeds
Not applicable Acceptable
2.9.1 Physical compatibility with other products
Not applicable, the product is not intended for mixing
Acceptable
2.9.2 Chemical compatibility with other products
Not applicable, the product is not intended for mixing
Acceptable
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
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 EFSA Scientific report on flutolanil (2008) 126; 1-63 (d.d. 3 March 2008), also taking into account the final review report on flutolanil (SANCO/116/08 –rev. 1, d.d. 16 May 2008). Where relevant, some additional remarks/information are given in italics.
3.1 Analytical methods in technical material and plant protection product Technical as (principle of method) GC-FID, packed column
Impurities in technical as (principle of method)
GC-FID; identification with GC-EIMS
Preparation (principle of method) GC-FID Conclusion
These analytical methods have been assessed in the Draft Assessment Report (DAR) and are considered to be acceptable.
3.2 Residue analytical methods Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)
GC-MSD, LOQ: 0.01 mg/kg flutolanil (potatoes) LC-MS/MS of AS, M-2 and M-4 LOQ: 0.01 mg/kg (potatoes)
ILV: LC-MS/MS of AS, M-2 and M-4 LOQ: 0.01 mg/kg (potatoes)
Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes)
Not relevant, as no residue definition and MRL is established.
Soil (principle of method and LOQ) GC/ MSD, 5 µg/kg flutolanil
HPLC/MS/MS, LOQ 0.01 mg/kg flutolanil Water (principle of method and
LOQ)
GC/TID, 0.1 µg/l flutolanil (drinking water) GC/TID, 1.0 µg/l flutolanil (surface water) Air (principle of method and LOQ) HPLC/UV, 2.7 µg/m3 flutolanil
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 matrices (ware and starch potatoes).
Definition of the residue and MRLs for flutolanil Matrix Proposed definition of the residue for
monitoring
Proposed MRL Food/feed of plant
origin
flutolanil 0.05 mg/kg
Food/feed of animal origin
none -
Required LOQ
Soil flutolanil 0.05 mg/kg
Drinking water flutolanil 0.1 µg/L (drinking water
guideline)
Surface water flutolanil 0.53 mg/L (NOEC for
Daphnia Magna)
Air flutolanil 0.168 mg/m3 (derived from
the AOEL (0.56 mg/kg) 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 MRL’s.
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 MRL’s and for monitoring of residues in the environment.
3.3 Data requirements None.
3.4 Physical-chemical classification and labelling
Supported shelf life of the formulation: two years in paper/PE/Alu/PE.
4. Mammalian toxicology List of Endpoints
Flutolanil is an existing active substance, included in Annex I of Directive 91/414/EEC. The final List of Endpoints presented below is taken from the EFSA Scientific Report on flutolanil (2008) 126; 1-63 (d.d. 20 March 2008). 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 oral absorption 70%; based on urinary excretion within 24h
Distribution Uniformly distributed
Potential for accumulation No evidence for accumulation
Rate and extent of excretion >95% excreted within 72 h via urine (70%) and faeces (26%)
Metabolism in animals Extensively metabolised; excreted as metabolites (mainly M-4) in urine and as unchanged flutolanil in faeces
Toxicologically relevant compounds (animals and plants)
Flutolanil and metabolites (M2 and M4)
Toxicologically relevant compounds (environment)
Flutolanil
Acute toxicity (Annex IIA, point 5.2)
Rat LD50 oral > 10,000 mg/kg bw
Rat LD50 dermal > 5,000 mg/kg bw
Rat LC50 inhalation > 5.98 mg/l air /4 h (whole body)
Skin irritation Non-irritant
Eye irritation Non-irritant
Skin sensitisation Non-sensitizing (M&K)
Short term toxicity (Annex IIA, point 5.3)
Target / critical effect Increased weight of liver (rat, dog) and thyroid/parathyroid (rat) and histopathological alterations in liver (dog)
Relevant oral NOAEL 299 mg/kg bw/d (90-d rat) 80 mg/kg bw/d (90-d dog) 680 mg/kg bw/d (90-d mouse) Relevant dermal NOAEL >1000 mg/kg bw/day (21-d rat) Relevant inhalation NOAEL No data available - not required
Genotoxicity (Annex IIA, point 5.4) No genotoxic potential 1
1 The genotoxic potential of flutolanil was investigated in six in vitro studies (Ames test, DNA repair test (Rec-assay), mammalian cytogenetic test in Chinese hamster lung cells, mammalian cytogenetic test in human lymphocytes, forward mutation test in mouse lymphoma cells and UDS test in rat hepatocytes) and in one in vivo study (micronucleus test in mouse bone marrow).
Long term toxicity and carcinogenicity (Annex IIA, point 5.5)
Target/critical effect Histological changes in spleen (rat);
Histological alterations in liver (male mouse) Clinical signs (emesis, salivation, excretion of soft faeces) (dog)
Relevant NOAEL 8.7 mg/kg bw/d (2-yr rat),
32 mg/kg bw/day (79-wk mouse), 50 mg/kg bw/d (2-yr dog)
Carcinogenicity No carcinogenic potential
Reproductive toxicity (Annex IIA, point 5.6) Reproduction toxicity
Reproduction target / critical effect Parental: increased liver weight
Reproduction and offspring: no effect up to the highest dose
Relevant parental NOAEL 157 mg/kg bw/day Relevant reproductive NOAEL 1614 mg/kg bw/day Relevant offspring NOAEL 1614 mg/kg bw/day
Developmental toxicity
Developmental target / critical effect Maternal: no effect up to the highest dose (rat and rabbit)
Foetal: no effect up to the highest dose (rat and rabbit)
Relevant maternal NOAEL >1000 mg/kg bw/d (rat and rabbit) Relevant developmental NOAEL >1000 mg/kg bw/d (rat and rabbit)
Neurotoxicity (Annex IIA, point 5.7)
Acute neurotoxicity No data available - not required Repeated neurotoxicity No data available - not required Delayed neurotoxicity No data available - not required Other toxicological studies (Annex IIA, point 5.8)
Mechanism studies No data available - not required
Studies performed on metabolites or impurities
No data available - not required
Medical data (Annex IIA, point 5.9)
No evidence of adverse effects to workers of manufacturing plants, agricultural workers and consumers
Summary (Annex IIA, point 5.10) Value Study Safety
bw/d
AOEL 0.56 mg/kg
bw/d
90-d dog study 100*
ARfD (acute reference dose) Not allocated, not necessary
*Corrected for oral absorption 70%
Dermal absorption (Annex IIIA, point 7.3)
SC formulation (461 g/L) In vitro study with human skin:2 Concentrate: 0.5%
Spray dilution (10%): 5%
2 See 4.2 Dermal absorption
Local effects
Flutolanil 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)
The formulation Symphonie does not need to be classified on the basis of its acute oral (LD50 rat >2000 mg/kg bw), dermal (LD50 rat >2000 mg/kg bw), and inhalation toxicology (LC50 rat >
5.13 mg/L).
The formulation Symphonie is considered irritating to eyes and needs to be classified as R36
‘Irritating to eyes’.
The formulation Symphonie is considered not irritating to skin.
No studies on sensitization with Symphonie have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.
4.1.1 Data requirements formulated product No additional data requirements are identified.
4.2 Dermal absorption (IIIA 7.3)
See List of Endpoints. In the in vitro dermal absorption study with human skin only the concentrate of the formulation Monarch was tested. After an exposure of 24 h, the amount of flutolanil in the receptor fluid was below the limit of quantification (<0.06%). 0.35% of the dose was found in epidermis. A rounded value of 0.5% was derived for the concentrate. The formulation Monarch can be diluted max. 10 fold, but there are no dermal absorption data available for the 10-fold dilution. This was discussed in the expert meeting (PRAPeR 24, June 2007) and it was proposed to use as worst case 5% for the 10-fold dilution. The Dutch expert did not agree, because the dermal depot is not saturated after exposure to the concentrate, nothing went through the skin and it is therefore not expected that dermal absorption of a 10-fold dilution will be significantly different compared to the concentrate.
However, the majority of the experts agreed to set a very conservative value of 5% for the 10-fold dilution, and this value will be used for the current risk assessment.
The tested formulation of Monarch contained 460 g/L flutolanil, which is considerably lower compared to Symphonie (60 g/L). As this is comparable to the 10% dilution stated in the LoEP the dermal absorption value of 5% can be used for Symphonie.
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 Symphonie.
4.4 Exposure/risk assessments 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 flutolanil no TLV has been set. The AOEL will be used for the risk assessment.
Since the formulation is applied once during the period March-April, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived.
Since flutolanil is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.56 mg/kg bw/day (= 39.2 mg/day for a 70-kg operator), based on the 90-day study in dog is used for the risk assessment (see List of Endpoints).
Exposure/risk
The models currently available for estimating operator exposure are not designed for seed treatment of potatoes. The applicant made reference to two exposure studies using similar formulation types (Stevens and Davis, 1981 and Jackson, 1995). During EPCO 14 it was concluded that the study by Steven and Davis is less suited to estimate operator exposure during dust applications in potatoes as it was performed under US specific conditions.
The study by Jackson 1995, which has been evaluated in the DAR for tolclofos-methyl, is suited to estimate operator exposure to flutolanil during dust applications of Symphonie in ware, starch and seed potatoes. The study was conducted at eight sites. At two of the sites, separate subjects conducted the loading and application tasks, while at the remaining six sites, a single subject completed both loading and application tasks. On average, subjects treated 7.8 tonnes of potatoes with 19.7 kg of Rizolex during a mean trial period of 414 minutes (6.9 hr). The average application rate of Rizolex was 253 g as/tonne. Study subjects wore the label-required personal protective clothing (coveralls), gloves, and respiratory equipment when loading the hopper and handling contaminated surfaces. Potential dermal exposures were assessed by sampling and analysing outer and inner clothing. Potential inhalation exposures were assessed using sampling pumps located in the breathing zone.
Potential dermal exposures and inhalation exposures to the active substance are summarised in the tables below.
Table 1: Dermal exposures to tolclofos-methyl assessed using outer clothing and cap
Based on the exposure study the average dermal exposure for the unprotected worker is 2.06 mg/kg bw/day. The average inhalation exposure is 0.025 mg/kg bw. However, based on the relatively low number of operators in the study, the highest measured exposures will be used for the risk assessment as a worst case (site 3: 0.106 and 4.51 mg/kg bw/d for
respiratory and dermal exposure respectively during loading and 0.005 and 0.427 mg/kg bw/d respectively for application tasks).
These values should be adjusted for a dermal absorption value of 5.0% and the difference in application rate between Rizolex and Symphonie (253 g/tonne and 90 g/tonne, respectively).
This leads to the following exposure values: ((4.51 * 0.05) + 0.106) * (90/253) = 0.12 mg/kg bw/day for the exposure during loading and (( 0.427 * 0.05) + 0.005) * (90/253) = 0.009 mg/kg bw/day. The combined exposure for the operator is 0.13 mg/kg bw, 23% of the 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 it is not necessary to perform any re-entry activities, including crop inspection tasks. Therefore no worker exposure is calculated.
Furthermore, Symphonie is a fungicide that is applied to potato tubers during the planting process only. After application the treated tubers fall to the ground and will be directly covered with soil. Therefore workers re-entering the treated field are not at risk to come into contact with Symphonie.
4.4.4 Re-entry
See 4.4.3 Worker exposure/risk.
Activity Trial
site/operator ref
Dermal exposure (outer clothing)
Dermal exposure (inner clothing)
Inhalation exposure mg/kg
bw/day
mg/kg a.i.
mg/kg bw/day
mg/kg a.i.
mg/kg bw/day Treatment Site 1/Loader 3.01 15.3 0.544 2.77 0.025
Site 3/Loader 4.51 14.02 1.019 3.17 0.106 Planting Site 1/Driver 0.521 2.96 0.277 1.57 0.004 Site 3/Driver 0.427 1.61 0.079 0.30 0.005 Treatment and
Planting
Site 2 2.79 10.25 0.89 3.28 0.042
Site 4 1.58 5.82 0.287 1.06 0.011
Site 5 2.21 9.19 0.469 1.95 0.006
Site 6 1.03 7.83 0.228 1.74 0.009
Site 7 3.47 10.05 0.456 1.32 0.022
Site 8 1.10 6.01 0.220 1.21 0.020
Mean 2.03 8.19 0.425 1.76 0.018
SD 0.97 1.96 0.253 0.82 0.013
Overall Mean 2.06 8.30 0.447 1.84 0.025
SD 1.36 4.40 0.302 0.97 0.031
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 flutolanil as a result of the application of Symphonie in ware, starch and seed potatoes.
Bystander exposure
The bystander exposure is only a fraction of the operator exposure. Based on the low risk- index for the operator, no adverse health effects to bystanders are expected.
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
Symphonie contains only one active substance and it is not described that it should be used in combination with other formulations.
5. Residues
Flutolanil is an existing active substance. The residue profile presented below is based on the Draft Assessment Report (DAR) prepared by the RMS Finland. The final List of
Endpoints presented below is taken from the EFSA Scientific report on flutolanil (2008) 126;
1-63 (d.d. 3 March 2008).
List of Endpoints Residues
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered Seed treatment : Potato (R)
Foliar treatment : peanut (P/O) and rice (C).
Rotational crops Oats (C), wheat (C), raddish (R), lettuce (L).
Metabolism in rotational crops similar to metabolism in primary crops?
Yes
Processed commodities Study on the effect of processing not required, considering the low residue level in raw potatoes
Residue pattern in processed commodities similar to residue pattern in raw
commodities?
Yes
Plant residue definition for monitoring Flutolanil.
Plant residue definition for risk assessment
Sum of flutolanil, metabolites M2 and M4 and their conjugates, expressed as flutolanil Conversion factor (monitoring to risk
assessment)
3 (for potatoes)
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered Not required
Time needed to reach a plateau
concentration in milk and eggs Not required Animal residue definition for monitoring Not required Animal residue definition for risk
assessment Not required
Conversion factor (monitoring to risk
assessment) Not required
Metabolism in rat and ruminant similar (yes/no)
Not required
Fat soluble residue: (yes/no) Not required
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
No residues of flutolanil were found in wheat and rape cultivated as rotational crops under field conditions.
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 Introduction) 18 months for potato, wheat (grain and straw) and rape (grain)
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3) Ruminant: Poultry: Pig:
Conditions of requirement of feeding studies Expected intakes by livestock ≥ 0.1 mg/kg
diet (dry weight basis) (yes/no - If yes, specify the level)
No No No
Potential for accumulation (yes/no): No No No
Metabolism studies indicate potential level of residues ≥ 0.01 mg/kg in edible tissues (yes/no)
No No No
Feeding studies (Specify the feeding rate in cattle and poultry studies considered as
relevant)
Residue levels in matrices : Mean (max) mg/kg
Muscle Not relevant Not relevant Not
relevant
Liver Not relevant Not relevant Not
relevant
Kidney Not relevant Not relevant Not
relevant
Fat Not relevant Not relevant Not
relevant
Milk Not relevant
Eggs Not relevant
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4) Crop/ process/ processed product Number of
studies
Processing factors Amount transferred (%)
(Optional) Transfer
factor
Yield factor Potato tuber/distribution in the
edible/non edible portion /peel
1 Not
required as residue level is low
Not relevant
Not calculated
Comments on/additions to List of Endpoints No comments.
5.1 Summary of residue data
The following assessment is based on the DAR and relevant addenda, a summary and evaluation of supervised residue trials by Ctgb (October 2012) and EFSA Scientific report on flutolanil (2008) 126; 1-63 (d.d. 3 March 2008). Flutolanil was discussed by the experts in residues in the PRAPeR meeting 25 (round 5, June 2007). Only the use on potatoes is assessed as the other crops in the intended use are not used for food or feed.
5.1.1 Metabolism in plants
A metabolism study in potatoes was conducted were potatoes underwent a seed treatment.
This metabolism study covers the intended use. Foliar and seed treatments result in similar metabolic pathways.
5.1.2 Metabolism in livestock
Due to low residue levels in treated crops. livestock exposure resulting from the representative use of flutolanil is very low and livestock metabolism studies are not necessary.
A goat metabolism study was nevertheless presented in the Annex II dossier. The study was not accepted by the peer review, but the same study was accepted by the JMPR (FAO, 2002). The Annex II dossier also contained a metabolism study in laying hen, which was considered acceptable.
5.1.3 Residue definition (plant and animal) Plant
The residue definition for monitoring is restricted to the parent compound as it can be
considered as a valid indicator for enforcement purposes. The expert meeting discussed the residue definition for risk assessment and agreed on the inclusion of metabolites M2 and M4 and their conjugates as they are considered, in the absence of any toxicological data, of the same level of toxicity as the parent compound, and expected to be present in consumer diet at levels similar to those of parent compound. A conversion factor from monitoring to risk assessment residue definition is also proposed, i.e. 3 for potatoes only.
Animal
According to the peer review, residue definitions in animal commodities are not proposed and not necessary. However, based on the available animal metabolism studies, the residue definition for enforcement and risk assessment for animal products is flutolanil and all
metabolites containing the 2-trifluromethylbenzoic acid moiety, expressed as flutolanil.
5.1.4 Stability of residues See LoEP.
5.1.5 Supervised residue trials
The DAR contains eight acceptable supervised residue trials in seed potato performed in Northern Europe. Seed potatoes received one treatment with flutolanil as an FS formulation of 87.7-131.5 g/tonne potatoes.
The cGAP-NL is one application of 90 g a.s. /tonne (25% deviation: +/- 22.5 g).
For this application for re-registration, two additional supervised residue trials were submitted where seed potatoes were treated with one application of 96.87 g as/tonne. Trials are
considered acceptable as they were performed in accordance with the current guidelines.
The residue levels selected for MRL setting and risk assessment are presented in table R1.
Table R1: Selected residue levels from trials with flutolanil Crop Residue levels selected for MRL setting
(mg/kg)
STMR (mg/kg)
HR (mg/kg) Potatoes
DAR <0.01 (2x), <0.022, 0.014 (2x), 0.022, 0.03, 0.035
0.014 0.035
Additional trials <0.01 (2x)
5.1.6 Residues in succeeding crops
Confined rotational crop studies indicated that the metabolic pathway in rotational crops is similar to that observed in primary crops although an additional route consisting in oxidation of the isopropyl moiety to alcohol and acid derivatives was observed. Parent compound under free or conjugated form was the major component of the residue. The residue
definitions proposed for primary crops would be evenly valid for rotational crops. A field study has been conducted and no residues were found in wheat and rape cultivated as
rotational crops.
No significant residues are expected in rotational crops. No label restriction related to rotational crops is needed.
5.1.7 Residues from livestock feeding studies
Feeding studies are not required as the trigger of 0.1 mg/kg diet was not exceeded.
5.1.8 Processing factors
Studies are not necessary as the theoretical daily intake (TDI) for potatoes is less than 10%
of the ADI.
5.1.9 Calculation of the ADI and the ARfD Calculation of the ADI
The ADI is based on the NOAEL of 8.7 mg/kg bw/d in the 2-year rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.09 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).
Calculation of the ARfD
No ARfD is derived, since flutolanil has no acute toxic properties.
5.2 Maximum Residue Levels
Temporary EU-MRLs are present in Annex IIIa of Regulation (EC) 396/2005. Recently, UK has submitted an MRL application to increase the MRL from 0.5 mg/kg to 0.6 mg/kg. This MRL application does not influence the assessment of Symphonie.
The product complies with the MRL Directives/Regulation.
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 temporary EU-MRLs (including the MRLs at the LOQ for not supported uses) and the conversion factor of 3 for potatoes. The maximum TMDI is 13.9% of the ADI for Dutch children. The TMDI is 6.0% of the ADI for the Dutch general population.
Risk assessment for acute exposure through diet
As no ARfD was derived for flutolanil, a risk assessment for acute exposure was not performed.
Conclusion
Based on the assessment for residues, no risk for the consumer due to the exposure to flutolanil is currently expected. The product complies with the Uniform Principles.
5.4 Data requirements
No data requirements were identified.
6. Environmental fate and behaviour
Flutolanil was included in Annex I on November 26th, 2008 (entry into force March 2009). The List of Endpoints of the EFSA conclusion is used for the assessment.
In the inclusion directive (PART B) the following is mentioned:
In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
Conditions of authorisation should include risk mitigation measures, where appropriate.
An additional study, a kinetic analysis of field trials, was evaluated and summarized by Alterra (Nov 2007, report no. 10579-mil). For the application for extension of Monarch (20090949), one additional field study was evaluated (Alterra report no. 23495-mil, October 2010). Evaluated endpoints of these studies are added to the List of Endpoints (below the field studies) in italics.
Moreover, for current application a kinetic analysis of water –sediment studies. A summary of this study including evaluated endpoints are added in italics below the list of endpoints.
List of Endpoints Fate/behaviour (in line with EFSA conclusion) Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1) (The percentages quoted are referred to the % of the applied radioactivity) Mineralization after 100 days ‡
([aniline ring-U-14C]-label)
- European soils: 2.9-9.9 % after 105 d (n1= 4), 20
oC
- US soil: 13.4 % after 116 d (27.5 % after 365 d) (n=1), 25 oC
Non-extractable residues after 100 days ‡ ([aniline ring-U-14C]-label)
- European soils: 9.4-27.9 % after 105 d (n=4), 20
oC
- US soil: 15.9 % after 116 d (26.7 % after 365 d) (n=1), 25 oC
Metabolites requiring further consideration ‡ - name and/or code, % of applied (range and maximum) ([aniline ring-U-14C]-label)
No (the only metabolite appearing over 5 % was CO2)
Route of degradation in soil – Supplemental studies (Annex IIA, point 7.1.1.1.2) Anaerobic degradation ‡
Mineralization after 100 days days ([aniline ring-U-14C]-label)
0.2 % / 120 d (0.4 % / 365 d) (n=1) Sterile conditions: no data available Non-extractable residues after 100 days
([aniline ring-U-14C]-label)
4.6 % / 120 d (7.4 % / 365 d) (n=1)
Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)
No (after 365 days total amount of flutolanil 86 %)
Soil photolysis ‡
Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)
The study is not relied upon (PRAPeR 22, May 2007), but it is not required for the representative use evaluated (seed treatment for potatoes prior planting)
1
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1) Laboratory studies ‡
Parent Aerobic conditions Soil type Org.
carbon2
pH t. oC / moisture (%)
DT50 /DT90
(d)
DT50 (d) 20 °C pF2/10kPa
St.
Min χ2
Method of calculation
Loamy sand 2.3 6.0 (KCl)
20 oC/100 % FC
115/3823 115 1.8 SFO
Sandy loam 2.4 7.1 (KCl)
20 oC/100 % FC
380/12623 380 1.1 SFO
Loam 1.0 7.2
(KCl)
20 oC/100 % FC
151/5013 151 0.9 SFO
Sand 0.6 7.4
(KCl)
20 oC/100 % FC
397/13183 397 2.1 SFO
Sandy loam 3.2 7.41 25 oC/75 % FC
110/3653 133 4.5 SFO
Loamy sand 2.2 5.7 (CaCl2)
10 oC/40 % MWH
295/9793 135 1.7 SFO
Geometric mean/median 190/143 (n =
6)
SFO
1 = based on average determinations on soil samples taken from the same location five years before the test started, no information on the measurement method
2 = calculated by the RMS
3 = calculated by the RMS by the equation DT90 = 3.32 x DT50
No metabolites requiring further consideration
Field studies ‡ field studies available, revised DT50 values not peer reviewed. *, **
pH dependence ‡
(yes / no) (if yes type of dependence)
No
Soil accumulation and plateau concentration ‡ No field accumulation studies
The plateau concentration (0.1301 mg/kg) was calculated to be achieved after 16 years (a 2-year rotation, 276 g as/ha) 1
1 = based on the worst case laboratory DT50 value of 412 days, as calculated in the original DAR;
agreed by PRAPeR 22 as worst case
* Ctgb added from EFSA conclusion: The view of the experts was that as the study design of the treated seed potato trials represents the intended use applied for flutolanil, the derived DT50s can be considered appropriate for PECsoil calculations (see section 4.1.3). However, no agreement could be reached on the suitability of the use of the field DT50 derived from the available field trials for FOCUS modelling.
** Ctgb: study submitted for the Dutch application for authorisation evaluated by Alterra (report no.
10579-mil, November 2007). During evaluation, some values were rejected and the data set was improved by first averaging DT50 values from the same soils). Individual values are: 152, 153, 171 (geomean of 140 and 208 d), 175 d (overall geomean normalised DT50 162 days, used for assessment of potato tuber treatment).
Ctgb, November 2012: the value of 140 d. should be excluded from the above DT50 endpoint calculation, as only the studies with tube treatment should be taken into account for this application.
New DT50 = 171 days (=geomean of 152, 153, 208 and 175).
Laboratory studies ‡
Parent Anaerobic conditions Soil type Org.
matte r (%)3
pH t. oC / % MWHC
DT50 / DT90 (d) DT50 (d) 20 °C pF2/10kPa
St.
(r2)
Method of calculation
Sandy loam 1.8 6.1 25 o/* 4917**/- 6378***/-
N.a.**** N.a.**** ****
Geometric mean/median
* = Water saturated soil
** = Test concentration 5 mg/kg
*** = Test concentration 50 mg/kg
**** = The first order decline curve was calculated based on the concentrations of flutolanil as a percentage of recovered radioactivity. However, very little degradation was detected over the course of the study (after 365 days total amount of flutolanil 86 %) and the substance can be classified as stable in anaerobic conditions.
No metabolites requiring further consideration
Soil adsorption/desorption (Annex IIA, point 7.1.2) Parent ‡
Soil Type Org.
matter
%
Soil pH Kd (mL/g)
Koc (mL/g)
Kf (mL/g)
Kfoc (mL/g)
1/n
Sand 0.2 6.5 - - 1.34 13401,3 1.164
Clay 2.4 6.7 - - 10.6 8831 0.909
Mississippi sediment 3.9 7.5 - - 10.3 5281 0.943
Clay loam 4.9 7.8 - - 16.0 6531 0.943
Sandy loam 6.2 6.1 - - 35.5 11501 0.980
Sand 0.3 8.0 (w) - - 0.996 5712,3 0.962
Loam 0.8 8.0 (w) - - 2.76 5942 0.855
Clay loam 4.9 7.4 (w) - - 13.0 4572 0.714
Clay loam 1.1 6.2 (w) - - 4.02 6282 0.901
Loamy sand 2.7 4.8 (w) - - 15.8 10052 0.926
Arithmetic mean/median/geometric mean 7814/641/735 0.93/0.935 /0.924
pH dependence, Yes or No No
1 = assuming organic matter (%) = 2.0 x organic carbon (%) 2 = assuming organic matter (%)= 1.72 x organic carbon (%)
3 = these values were omitted in PECgw modelling due to their low organic matter content
4 = the arithmetic mean value used in PECgw modelling (683, n = 8) was calculated assuming organic matter = 1.724 x organic carbon
No metabolites requiring further consideration
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
Column leaching ‡ Eluation (mm): 200 mm
Time period (d): 2 d
Leachate: less than 0.24 % total residues/radioactivity in leachate
The radioactivity of soil column was not analyzed.
Aged residues leaching ‡ After 8 months of aging flutolanil still accounted for 84 % of the extracted radioactivity. Thus it was considered inappropriate to continue the
experiment and the study was found unnecessary.
Lysimeter/ field leaching studies ‡ Not considered necessary
Route and rate of degradation in water (Annex IIA, point 7.2.1) Hydrolytic degradation of the active substance
and metabolites > 10 % ‡
Photolytic degradation of active substance and metabolites above 10 % ‡
Stable to hydrolysis (pH 5-9: at the end of a 30-day study recovery of applied radioactivity 103-108 %, flutolanil accounted for 98.3-99.5 %, no hydrolysis products were observed)
DT50: 277 d (SFO, r2 = 0.812) No relevant metabolites Xenon arc lamp, 30 d Quantum yield of direct phototransformation in
water at Σ > 290 nm N.a.
Readily biodegradable ‡ (yes/no)
No (the change of BOD/28 days was 0 %)
Degradation in water / sediment
Parent Distribution (max in water 96.8-97.8 % after 0.25 d. Max. sed 34.0-68.7 % after 30 d) Water /
sediment system
pH water phase
pH sed
t. oC DT50-DT90 whole sys.
St.
(r2)
DT50- DT90 water
St.
(r2)
DT50- DT90 Sed
St.
(r2)
Method of calculation
Pond, NL 8.31- 7.02
7.3 20 90-299 0.987 53-176 0.878 n.a. n.a. SFO
n.a. n.a. 25-274 0.984 n.a. n.a. SQRT 1. order Ditch, NL 7.21-
6.52
6.7 20 244-811 0.956 33-110 0.623 n.a. n.a. SFO
543-5992 0.952 n.a. n.a. n.a. n.a. SQRT 1. order n.a. n.a. 3.4-92 0.911 n.a. n.a. SQRT 1.5 order
1 = before study start 2 = study end
No metabolites requiring further consideration
Mineralization and non-extractable residues Water /
sediment system
pH water
pH sed Mineralization
x % after n d. (end of the study)
Non-extractable residues in sed.
max x % after n d (end of the study)
Pond, NL 8.31- 7.02
7.3 5.2 % after 105 d 26.3 % after 105 d
Ditch, NL 7.21- 6.52
6.7 3.7 % after 105 d 15.1 % after 105 d
1 = before study start 2 = study end
PEC (ground water) (Annex IIIA, point 9.2.1) Method of calculation and type of study (e.g.
modelling, field leaching, lysimeter )
For FOCUS gw modelling, values used – Model(s) used:
FOCUS PRZM V2.4.1 and FOCUS PEARL V3.3.3:
Scenarios: Chateaudun, Hamburg, Jokioinen, Kremsmünster, Okehampton, Piacenza, Porto, Sevilla, Thiva
Crop: Potatoes
DT50, parent: 190 d (geometric mean, n=6,
ModelMaker optimization and normalisation to pF2, 20 oC with Q10 of 2.2) *
Kfoc, parent: 683 L/kg (arithmetic mean, n=8, the sand soils were omitted from the calculations due their low organic matter content) 1/n= 0.896
Metabolites: No metabolites requiring further consideration
Lysimeter or field leaching studies were not carried out.
Application rate Application rate: 276 g/ha (potato seed planting rate 3000 kg/ha, incorporation depth 20 cm)
No. of applications: 1 application/2 years (a 2-year crop rotation period)
Time of application: the date of planting for PEARL, 15 days pre-emergence for PRZM (January-May)
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
Direct photolysis in air ‡ No data available (flutolanil has a low vapour pressure, 4.7 x 10-8, and as such its concentration in the atmosphere is likely to be negligible) Quantum yield of direct phototransformation No data available (flutolanil is not susceptible to
direct phototransformation and therefore it is not possible to determine the quantum yield)
