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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: examination of reproductive organs
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:
The reproductive organs were examined as part of the 28-day study,
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: other TS: p-cresol, Purity > 98 %

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
see section 7.5.1
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

Effect levels

Dose descriptor:
NOAEL
Effect level:
2 060 mg/kg bw/day
Based on:
test mat.
Sex:
male

Observed effects

Histopathological examination revealed no effects on the reproductive organs.

Any other information on results incl. tables

Histopathological examination revealed no effects on the reproductive organs.

Applicant's summary and conclusion