Registration Dossier
Registration Dossier
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EC number: 206-996-5 | CAS number: 420-46-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 483 (Mammalian Spermatogonial Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Norflurane
- EC Number:
- 212-377-0
- EC Name:
- Norflurane
- Cas Number:
- 811-97-2
- Molecular formula:
- C2H2F4
- IUPAC Name:
- 1,1,1,2-tetrafluoroethane
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- 6 hours / day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1000, 10000, 50000ppm
Basis:
- No. of animals per sex per dose:
- 15 males / 30 females
- Control animals:
- yes, concurrent no treatment
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Negative controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
In a dominant lethal assay, CD1 male mice were exposed to up to 50000ppm HFC 134a for 5 days. After the last exposure, each male was housed with 2 virgin females for 4 consequetive nights. Further matings with new females were conducted at weekly intervals for a total of 8 times. The study indicated that HFC 134a did not affect male fertility or cause mutagenic effects through sperm.
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