Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Additional information

Oral administration of 0.4, 2.0, 10.0, 25.0 and 50.0 mg/kg/day of 2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid (i.e. the racemate) to pregnant rats from 7 days to day 17 of gestation produced no maternal or foetal effects in a preliminary teratogenicity study. The only available data is from a brief summarised secondary source, and as such is considered to be unreliable and inadequate for risk assessment and classification purposes.

Justification for classification or non-classification

The data described above are inadequate for classification and labelling. However the following information is relevant for classification and labelling of this substance:

Fluazifop-P-butyl (CAS No: 79241-46-6; butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy) phenoxy]propionate) is an active substance used in plant protection products.

Fluazifop-P (CAS# 83066-88-0; (2R)-2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid; i.e. the same substance as defined in section 1) is the major systemically available metabolite of the active substance.

Fluazifop-P-butyl is listed in Regulation (EC) 1272/2008, Annex VI (Table 3.1: list of harmonised classification and labelling of hazardous substances and Table 3.2: list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) with Index No. 607-305-00-3.

The corresponding information on classification and labelling with respect to reproductive toxicity are:

Table 3.1: Repr. 2; H361d

Table 3.2: Repr. Cat. 3; Xn, R63

 

There is strong evidence to suggest that fluazifop-P-butyl rapidly metabolizes in vivo to fluazifop-P. For this reason the test(s) with the active substance which lead(s) to the classification mentioned above can in principle also be considered as a test performed with fluazifop-P. For this reason the corresponding classification and labelling with respect to reprotoxicity of the active substance is also adopted for fluazifop-P.