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Toxicological information

Genetic toxicity: in vivo

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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:
1979
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

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.: 14.006.683

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.