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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
endocrine system modulation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
09.11.2001 - 14.12.2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: OECD 440 Uterotrophic Bioassay in rodents: A short-term screening test for oestrogenic properties
GLP compliance:
yes
Type of method:
in vivo
Endpoint addressed:
toxicity to reproduction / fertility

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Alpk:APfSD (Wistar derived)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
3 days
Frequency of treatment:
single oral dose once a day
Post exposure period:
24 hrs
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw/d
Basis:

No. of animals per sex per dose:
The study consisted of one vehicle control, one positive control (17 ß-estradiol benzoate) and three treatment groups, with 10 female rats each group.
Control animals:
yes, concurrent vehicle

Results and discussion

Applicant's summary and conclusion

Executive summary:

 There was no evidence of a uterotropic response with the test substance.