Registration Dossier
Registration Dossier
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EC number: 200-164-5 | CAS number: 53-16-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- 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 substance name:
- Estradiol
- EC Number:
- 200-023-8
- EC Name:
- Estradiol
- Cas Number:
- 50-28-2
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estra-1,3,5(10)-triene-3,17-diol
- Details on test material:
- - Name of test material (as cited in study report): estradiol
Constituent 1
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
- Basis for effect level:
- other: liver toxicity
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.
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