Registration Dossier
Registration Dossier
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EC number: 200-350-6 | CAS number: 57-83-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 11. Nov 1991 to 24. March 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- GLP compliance:
- yes
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
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.: 50792330
Constituent 1
Method
- Target gene:
- unspecified
Species / strain
- Species / strain / cell type:
- hepatocytes: primary culture, male rat
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 0.00128 up to10 µg/ml
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
Results and discussion
Test results
- Species / strain:
- hepatocytes: primary cultures, male rats
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Progesterone has no genotoxic activity nor any potential to induce S-phase synthesis. Classification of progesterone is not required. - Executive summary:
In two experiments primary hepatocytes of male rats were incubated overnight with progesterone in different concentrations.
In both experiments the top concentration scored was limited by toxicity and solubility.
No unscheduled DNA synthesis or S-phase synthesis was induced. Classification of progesterone is not required.
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