Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
GLP compliance:
no
Type of assay:
rodent dominant lethal assay

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
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 5686 (gestonorone), results of studies with an ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative since most likely ester ceavage occurs in vivo after application.

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.