Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
other information
Study period:
7. Jul 1994 to 3. Aug 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not applicable
GLP compliance:
yes (incl. certificate)
Type of assay:
other: DNA adduct

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): estradiol

- Name of test material (as cited in study report): estradiol
- Lot/batch No.: 22054909
- Expiration date of the lot/batch: June 1997

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
14 days
Frequency of treatment:
daily
Post exposure period:
no
Doses / concentrations
Remarks:
Doses / Concentrations:
2 mg/kg
Basis:
no data
No. of animals per sex per dose:
3/sex/group
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
DNA adduct analysis on liver samples.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
not examined

Any other information on results incl. tables

Body weight gain decreased in female rats. DNA adduct spots of estradiol were detected after administration in male rat liver cells.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): ambiguous
DNA adduct spots were observed in male rat liver cells. No correlation between DNA adduct formation and tumorigenic potential detected.
Executive summary:

After 14 days oral treatment with estradiol decreased body weight gain was observed in female rats and

DNA adducts were detected in male rat liver cells. There is no correlation between DNA adduct formation and tumorigenic potential observed.