Registration Dossier
Registration Dossier
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EC number: 200-004-4 | CAS number: 50-03-3
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 31. Mar to 20. Apr 1976
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: wel reported study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Hydrocortisone 21-acetate
- EC Number:
- 200-004-4
- EC Name:
- Hydrocortisone 21-acetate
- Cas Number:
- 50-03-3
- Molecular formula:
- C23H32O6
- IUPAC Name:
- 11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): hydrocortisone 21-acetate
- Lot/batch No.: 16384
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- day 6 to day 15 of pregnancy
- Frequency of treatment:
- daily
- Duration of test:
- termination on day 19 of pregnancy
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.2 and 2 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 8/group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 0.2 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:yes. Remark: embryotoxic at 2 mg/kg bw
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Reduces body weight gain in dams and suspicion of embryolethality in high dose group.
Applicant's summary and conclusion
- Conclusions:
- NOAEL 0.2 mg/kg based on reduced body weight gain of dams and embryolethality at 2 mg/kg
- Executive summary:
Daily subcutaneous application of hydrogortisone 21 -acetate to female rats on pregnancy day 6 to 15 in doses of 0, 0.2 and 2.0 mg /kg results in reduces body weight gain in dams and suspicion of embryolethality in high dose group. NOAEL 0.2 mg/kg
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