Registration Dossier
Registration Dossier
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EC number: 218-378-2 | CAS number: 2137-18-0
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- castor oil
- Remarks:
- with benzyl benzoat
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- treatment on day 0 and 4 of pregnancy
- Frequency of treatment:
- once/day
- Duration of test:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2 - 20 - 200 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- Groups of 21, 20 or 19 pregnant rats
(21 animals for control) - Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- > 200 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- > 200 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Gestonorone caproate was not teratogenic in rats
- Executive summary:
No reproductive toxicity studies were conducted with ZK 5686 (gestonorone). Results of studies conducted with an ester of gestonorone (ZK 5623, gestonorone caproate) are regarded as representative as most likely ester cleavage occurs in vivo after administration.
The effect of ZK 5623 on early embryonic development was studied in rats after subcutaneous administration of doses of 0/ 2/ 20/ 200 mg/kg on Days 0 and 4 p.c. No effects on pregnancy and embryo-fetal development were seen in this study.
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