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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: sub-chronic gavage study comparable to OECD TG408 with data relating to fertility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Principles of method if other than guideline:
Effects on reproductive organs in a 90 d gavage study comparable to OECD Guide-line 408.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Samples analysed by gas chromatography before, during, and after the study; purity >= 95%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
Exposure period: 91-92 days
Frequency of treatment:
once daily, 5 days per week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 50, 500, 5000 mg/kg bw/day
Basis:

Control animals:
yes, sham-exposed

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
5 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: effects on reproductive organs in a 90-day gavage study

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
5 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: effects on reproductive organs in a 90-day gavage study

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Due to the decreased body weight the mean relative organ weights of testes were significantly higher in males of the high dose group; however, no significant effects were seen with the mean absolute testes weights (no toxicological relevance, no changes in histopathology). No effect on other organ weights mentioned under test condition.
Pathology/histopathology: no changes related to the test
 substance in any organ mentioned under test condition.

Applicant's summary and conclusion

Conclusions:
In the subchronic gavage study in rats no effects on reproductive organs were found at dose levels up to 5000 mg/kg bw/day.
Executive summary:

Comparable to OECD guideline 408.

Details of this study are presented in Section 7.5.1.

In the subchronic gavage study in rats no effects on reproductive organs were found at dose levels up to 5000 mg/kg bw/day.