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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
