Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only very little information is available. The information is based on an internal memorandum with a short summary of the results of a study report. The full study report is not available.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1981

Materials and methods

GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test substance is the racemate 2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid (CAS# 69335-91-7). It is a 1:1 mixture of the two enantiomers (2R)-2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid (CAS# 83066-88-0; the substance defined in section 1) and (2S)-2-(4-{[5-(trifluoromethyl)pyridin-2-yl]oxy}phenoxy)propanoic acid (CAS# 95977-30-3).

Test animals

Species:
rat
Strain:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Full information as given in the memorandum:

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.

Remark: In the internal memorandum the dose levels were given as "0.4, 2.0, 10.0, 25.0 and 50.0 mg/g/day". It is assumed that this is due to a typing error and "mg/g/day" should read as "mg/kg/day". All dose levels refer to the test substance (i.e. the racemate).

Applicant's summary and conclusion