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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1997
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Reproductive and Developmental Toxicity of Degradation Products of Refrigerants in Experimental Animals
Author:
Ema M et al.
Year:
2010
Bibliographic source:
Reproductive toxicology 29, 1-6
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Female rats were exposed by oral route to trifluoroacetic acid during the gestation (from day 10 to day 20). On day 21, the delivery occured and then the pups were examined until day 49 postnatal (PND 49).
GLP compliance:
not specified
Remarks:
No information available.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on mating procedure:
not indicated
Duration of treatment / exposure:
10 days: the test substance was administered from GD 10 to GD 20.
Frequency of treatment:
daily
Duration of test:
not indicated
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 75, 150 mg/kg bw/d
Basis:
nominal in water
No. of animals per sex per dose:
not indicated (around 40 pregnant females per dose and control)
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
> 150 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Effect levels (fetuses)

Basis for effect level:
other: not specified
Remarks on result:
not determinable because of methodological limitations

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion