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Toxicological information

Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study: repeated dose toxicity
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Principles of method if other than guideline:
Type: other
Method: other: the reproductive organs were examined as part of the 28-day study, see chapter 5.4
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: purity>98 %

Test animals

Species:
rat
Strain:
other: Fisher 344/N
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
28 d
Frequency of treatment:
continuously in diet
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 300, 1000, 3000, 10000, 30000 ppm
Basis:

Control animals:
yes, concurrent no treatment
Details on study design:
Duration of test: 28 d

Results and discussion

Observed effects

see freetext RS

Any other information on results incl. tables

RS-Freetext:
Histological evaluation , characterized by average severity score based on a scale of 1 to 4 (1=minimal, 2=mild, 3=moderate, 4= marked) revealed effects:
uterine atrophy in 4/5 females at 30000 ppm

Applicant's summary and conclusion