Registration Dossier
Registration Dossier
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EC number: 200-350-6 | CAS number: 57-83-0
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:
- other information
- Study period:
- 24. Jan to 30. Aug 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Progesterone
- EC Number:
- 200-350-6
- EC Name:
- Progesterone
- Cas Number:
- 57-83-0
- Molecular formula:
- C21H30O2
- IUPAC Name:
- pregn-4-ene-3,20-dione
- Details on test material:
- - Name of test material (as cited in study report): progesterone
- Lot/batch No.: 14.006.683
Constituent 1
Test animals
- Species:
- monkey
- Strain:
- other: Macacus mulatta
- Sex:
- female
Administration / exposure
- Route of administration:
- subcutaneous
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- daily
- Post exposure period:
- no
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5, 5.0 or 50.0 µg/ml
Basis:
nominal conc.
- No. of animals per sex per dose:
- 4/group
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- smear of sternal bone marrow, examination for erythrocyte micronuclei
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
For none of the doses of progesterone could mutagenic effects be detected by mean of the micronucleus test on female rhesus monkeys after 12 weeks of treatment. - Executive summary:
Female monkeys were treated with progesterone subcutaneously over 12 weeks and bone marrow was taken afterwards for micronucleus examination. There was no increase of micronuclei found compared to untreated control animals. Classification is not required.
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