Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Short description of key information:
No data available for effects on fertility.

Effects on developmental toxicity

Additional information

Oral administration of 0.4, 2.0, 10.0, 25.0 and 50.0 mg/kg/day 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. Information on a related substance is available from the harmonised classification and labelling listed in Annex VI to Regulation (EC) No. 1272/2008 (see classification justification).

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:

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

(2R)-2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid (CAS No: 83066-88-0) is the major systemically available metabolite of the active substance.

In buffered biological systems, potassium (2R)-2-[4-[[5-trifluoromethyl-2-pyridinyl]oxy]phenoxy]propanoate will dissociate and form essentially the same chemical species as (2R)-2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid.

Butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy) phenoxy]propionate is listed in Regulation (EC) No. 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 Butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy) phenoxy]propionate rapidly metabolizes in vivo to (2R)-2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid, thereby forming essentially the same chemical species as dissociated potassium (2R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate. For this reason the corresponding classification and labelling with respect to reprotoxicity of the active substance is also adopted for potassium (2R)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate.

Additional information