Registration Dossier
Registration Dossier
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EC number: 250-882-8 | CAS number: 31981-44-9
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Type of method:
- in vivo
Test material
- Reference substance name:
- Gestonorone caproate
- EC Number:
- 215-010-2
- EC Name:
- Gestonorone caproate
- Cas Number:
- 1253-28-7
- Molecular formula:
- C26H38O4
- IUPAC Name:
- 17-acetyl-3-oxoestr-4-en-17-yl hexanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- castor oil
- Remarks:
- with benzyl benzoat
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Days 17 and 20 p.c. and during the weaning period (Days 1, 4, 7, 10, 13, 16 and 19 p.p.)
- Frequency of treatment:
- daily
- 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:
- 20, 24 or 22 pregnant rats/group
(18 control rats) - Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day
- Basis for effect level:
- other: prevent spontaneous delivery
Observed effects
Applicant's summary and conclusion
- Conclusions:
- Gestonorone caproate did prevent spontaneous delivery
- Executive summary:
No reproductive toxicity studies were conducted with ZK 5624 (gestonorone acetate). Results of studies conducted with a different ester of gestonorone (ZK 5623, gestonorone caproate) are regarded as representative as most likely ester cleavage occurs in vivo after administration.
The effect of gestonorone caproate (ZK 5623) on peri- and postnatal development (effects on dams, reared pups of F1 generation and F2 fetuses) was assessed by subcutaneous treatment of rats (P generation) at end of pregnancy (Days 17 and 20 p.c.) and during the weaning period (Days 1, 4, 7, 10, 13, 16 and 19 p.p.) with doses of 2, 20 and 200 mg/kg. At the high dose, spontenous delivery was prevented by treatment in nearly all animals. Only dead fetuses were detected in high dose animals sacrificed on Day 24 p.c. No effects of ZK 5623 were seen on any of the other parameters assessed in this study at the two lower doses tested.
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