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Toxicological information

Developmental toxicity / teratogenicity

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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:
1978
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

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:
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.