Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): gestonorone caproate

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.