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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientifically sound study/ publication. No guideline available for such kind of investigation. However, the result obtained is valuable.

Data source

Reference
Reference Type:
publication
Title:
Trifluoroethanol and Its oxidative Metabolites: Comparison of in vivo and in vitro Effects in Rat Testis
Author:
Lloyd SC et al.
Year:
1988
Bibliographic source:
Toxicology and Applied Pharmacology 92, 390-401
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In this in vivo study a single dose of the test substance was administered to male rats by oral route. 3 days after the treatment, the testes were removed for histopathological observations.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Alpk/AP (Wistar derived)
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on mating procedure:
Not applicable: no mating was performed. Male fertility was investigated.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
single dose
Frequency of treatment:
single dose
Details on study schedule:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, 25 mg/kg bw
Basis:
other: nominal in water in 5 mL water/kg bw, adjusted to pH 7 using 1.0 M NaOH
No. of animals per sex per dose:
10 males per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Remarks:
fertility
Effect level:
25 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: after single dose treatment

Results: F1 generation

Effect levels (F1)

Basis for effect level:
other: F1 generation was not assessed
Remarks on result:
not measured/tested

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion