Registration Dossier
Registration Dossier
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EC number: 206-825-4 | CAS number: 378-44-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. Therefore, although the method is unknown, the values presented here are acceptable as they are from a reliable secondary source of biological data.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Betamethasone
- EC Number:
- 206-825-4
- EC Name:
- Betamethasone
- Cas Number:
- 378-44-9
- Molecular formula:
- C22H29FO5
- IUPAC Name:
- 9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- no data
- Frequency of treatment:
- two intraperitoneal injections, 24 hours apart.
- Post exposure period:
- 24 or 48 hours after dosing.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
250
Basis:
nominal conc.
mg/kg bw/day
- Remarks:
- Doses / Concentrations:
500
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1000
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 male and 5 female
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- within the historical control range
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Any other information on results incl. tables
At 48 hour sampling time, statistically significant increases in micronucleated polychromatic erythrociteswere observed in males (but not females) given 250 and 500 (but not 1000) mg/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In the EMEA literature was reported to be a negative result.
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