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Toxicological information

Genetic toxicity: in vitro

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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:
1992
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

Constituent 1
Chemical structure
Reference substance name:
Progesterone
EC Number:
200-350-6
EC Name:
Progesterone
Cas Number:
57-83-0
Molecular formula:
C21H30O2
IUPAC Name:
(1S,3aS,3bS,9aR,9bS,11aS)-1-acetyl-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
Details on test material:
- Name of test material (as cited in study report): progesterone
- Lot/batch No.: 50792330

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.