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Toxicological information

Developmental toxicity / teratogenicity

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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:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
not specified
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hydrocortisone 21-acetate
- Lot/batch No.: 16384

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