Registration Dossier
Registration Dossier
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EC number: 250-882-8 | CAS number: 31981-44-9
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported pre-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): gestonorone caproate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- subcutaneous
- Duration of treatment / exposure:
- 7 weeks
- Frequency of treatment:
- twice weekly
- Post exposure period:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2 - 20 - 200 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- no data
- Control animals:
- other: positive control: TEM in drinking water
Examinations
- Tissues and cell types examined:
- Mating plug, pregnancy, number of death fetuses, total implants, bw,
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No classification required - Executive summary:
No mutagenicity assay was performed with ZK 5624 (gestonorone acetate), results of studies with a different ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative:
Results of a dominant-lethal test in mice with ZK 5623 did not indicate a mutagenic potential up to the highest tested dose of 200 mg/kg.
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