Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Test substance was administered to rats daily via gavage for 5 days.
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): estradiol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
5 days treatement afterwards 7 days recovery before necropsy
Frequency of treatment:
daily for 5 days
Doses / concentrations
Remarks:
Doses / Concentrations:
20 and 300 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
3/sex/group
Control animals:
other: 0.9% (w/v) NaCl

Results and discussion

Effect levels

Dose descriptor:
NOEL
Effect level:
< 20 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

transient decrease in water consumption (male) and body weight gain (male and female)

Applicant's summary and conclusion

Conclusions:
no liver toxicity observed
Executive summary:

Rats were treated orally via gavage with estradiol over 5 days and subsequent 7 days recovery before sacrifice.

Decreased water consumption (male) and body weight gain (both sexes) could be observed. Liver toxicity of estradiol could not be identified.