Registration Dossier
Registration Dossier
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EC number: 200-929-3 | CAS number: 76-05-1
Toxicity to reproduction
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:
- 1 988
- 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 substance name:
- Trifluoroacetic acid
- EC Number:
- 200-929-3
- EC Name:
- Trifluoroacetic acid
- Cas Number:
- 76-05-1
- Molecular formula:
- C2HF3O2
- IUPAC Name:
- trifluoroacetic acid
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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