MAF 1 Drift fraction / Vegetation factor 2
10 Classification and labelling
Proposal for the classification and labelling of the formulation
Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed:
Based on Reg. (EC) 1272/2008:
The identity of all substances in the mixture that contribute to the classification of the mixture *:
Metobromuron
Pictogram: GHS08 Signal word: Warning
GHS09
H-statements: H351 Suspected of causing cancer.
H373 May cause damage to organs through prolonged or repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.
P-statements: P260 Do not breathe
dust/fume/gas/mist/vapours/spray.
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P391 Collect spillage.
P501 Dispose of contents/container to
hazardous or special waste collection point Supplemental Hazard
information:
EUH208 Contains metobromuron and
1,2-benzisothiazolin-3-one. May produce an allergic reaction.
EUH401 To avoid risks to human health and the environment, comply with the instructions for use.
SP 1-statement:
(gewas)
SP1 Do not contaminate water with the product or its container
Child-resistant fastening obligatory? Not Applicable Tactile warning of danger obligatory? Not Applicable Explanation:
Pictogram: according to Reg. (EC) 1272/2008.
H-statements: according to Reg. (EC) 1272/2008.
P-statements: P260 is highly recommended for products classified H373.
P301+P312 and P308+P313 are not (highly)
recommended P-statements for this product intended for professional use.
Other: EUH208 has also to mention 1,2-benzisothiazolin-3-one.
SP1 according to Reg. (EU) No 547/2011.
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
The following restriction sentences have to be included in the Legal Instruction:
In verband met residuen in volggewassen mogen direct na het mislukken van de teelt alleen wortelgewassen en bladgewassen geteeld worden. In de eerstvolgende 6 maanden na toepassen mogen geen granen worden geteeld. Een jaar na toepassen mogen alle gewassen worden geteeld.
Om niet tot de doelsoorten behorende geleedpotigen en terrestrische planten te beschermen is toepassing van het middel in de teelt van aardappels uitsluitend toegestaan wanneer gebruik gemaakt wordt van 50% driftreducerende spuitdoppen in combinatie met een kantdop.
Mocht de behandelde teelt in het voorjaar mislukken dan wordt afgeraden om koolgewassen, koolzaad of suikerbieten als vervanggewas te gebruiken. Voor het zaaien of planten van allerlei volgteelten wordt een kerende grondbewerking d.m.v. ploegen aangeraden.
Resistentiemanagement
Dit middel bevat de werkzame stof metobromuron. Metobromuron behoort tot de Ureum verbindingen. De Hrac code is C2.
Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
Toelatingsnummer 14698 N
Ap p endix 1 Table o f authorise d use s
Toelatingsnummer 14698 N
Ap p endix 2 Refere nce list Annex
point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
IIA 5.8
2014a In vitro assessment of HHAC-026 in the micronucleus test in cultured human peripheral lymphocytes - according to OECD Guideline 487;
LPT GmbH & Co KG, Germany; Report no. 31005;
GLP, unpublished
Y Belchim 20110501
TG
29-10-2014
IIA 5.8
2014b In vitro assessment of 4-bromophenylurea in the micronucleus test in cultured human peripheral lymphocytes - according to OECD
Guideline 487;
LPT GmbH & Co KG, Germany;
Report no. 31003;
GLP, unpublished
Y Belchim 20110501
TG
29-10-2014
IIA 5.8
2014c In vitro assessment of HHAC-025 in the micronucleus test in cultured human peripheral lymphocytes - according to OECD Guideline 487;
LPT GmbH & Co KG, Germany;
Report no. 31004;
GLP, unpublished
Y Belchim 20110501
TG
29-10-2014
* in case of an earlier submission (for an earlier application)
Toelatingsnummer 14698 N
Part B - List of Annex III data submitted in support of the evaluation Annex
point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner Application number*
Date of submission*
KIIIA 2.1/01
2010a PHYSICAL AND CHEMICAL PROPERTIES OF
METOBROMURON 500 G/L SC AFTER ACCELERATED STORAGE
Batelle UK LTD.
Belchim Crop Protection, Isernhagen, Germany Report-no. OZ/10/004/1
GLP: yes Published: no
yes BCP 20110501 TG 17/11/2011
KIIIA 2.2.1/01
2010 PHYSICOCHEMICAL TESTING ON A SAMPLE OF METOBROMURON 500 SC
Chilworth Technology Limited, Southampton, UK Belchim Crop Protection, Isernhagen, Germany Report-no. GLP104802R1V1/10
GLP: yes Published: no
yes BCP 20110501 TG 17/11/2011
KIIIA 2.7.1/01
2010b PHYSICAL AND CHEMICAL PROPERTIES OF
METOBROMURON 500 G/L SC AFTER STORAGE FOR 2 WEEKS AT 54°C
Batelle UK LTD.
Belchim Crop Protection, Isernhagen, Germany Report-no. OZ/10/004/3
GLP: yes Published: no
yes BCP 20110501 TG 17/11/2011
KIIIA 2.7.5/01
2012 PHYSICAL AND CHEMICAL PROPERTIES OF
METOBROMURON 500 G/L SC: STORAGE STABILITY FOR UP TO 104 WEEKS AT 23°C IN ORIGINAL CONTAINERS
Batelle UK LTD.
Belchim Crop Protection, Isernhagen, Germany Report-no. OZ/10/004/2
GLP/GEP: yes Published: no
yes BCP 20110501 TG 07/03/2013
Toelatingsnummer 14698 N
KIIIA 5.2.1/01
2010 VALIDATION OF THE ANALYTICAL METHOD FOR THE DETERMINATION OF METOBROMURON IN 500 SC.
BATELLE UK LTD.
BELCHIM CROP PROTECTION, ISERNHAGEN, GERMANY REPORT-NO. OZ/10/005/1
2010a BCP 222H: EVALUATION OF ACUTE ORAL TOXICITY IN RATS, ACUTE TOXIC CLASS METHOD
REPORT-NO. TAO423-PH-10/0026
2010b BCP 222H: EVALUATION OF ACUTE DERMAL TOXICITY IN RATS
2010c BCP 222H: ASSESSMENT OF ACUTE DERMAL IRRITATION REPORT-NO. IC-OECD-PH-10/0026
2010d BCP 222H: ASSESSMENT OF ACUTE EYE IRRITATION REPORT-NO. IO-OCDE-PH-10/0026
2010e BCP 222H: ASSESSMENT OF SENSITIZING PROPERTIES ON ALBINO GUINEA PIGS, MAXIMIZATION TEST ACCORDING TO MAGNUSSON AND KLIGMAN
2010 METOBROMURON 500 SC - IN VITRO ABSORPTION THROUGH HUMAN AND RAT EPIDERMIS USING [14C]-METOBROMURON
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Toelatingsnummer 14698 N
IIIA 10.1.2/02
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* in case of an earlier submission (for an earlier application)
Deze appendix geeft een indicatief overzicht van de gegevens die voor het eerst gebruikt zijn ten behoeve van een besluit; het kan echter voorkomen dat (onder andere) door een samenloop van aanvragen, de hier opgenomen gegevens al eens eerder gebruikt zijn. Aan dit overzicht kunnen dan ook geen rechten ontleend worden.