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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is specified in the report.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Biorex
Sex:
male

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
3, 12 and 27 weeks
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
100 mg/kg bw/day
Dose / conc.:
500 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
5 male animals per dose were used for the fertility test after 3, 12 and 27 weeks of treatment.
Control animals:
yes, plain diet
Details on study design:
The test was performed by mating each male with 5 females of proven fertility for 4 days then females were killed 14 days later.

Examinations

Postmortem examinations (parental animals):
SACRIFICE
- Maternal animals: All females were sacrificed 14 days after mating.

GROSS NECROPSY
- The number of pregnant females, corpora lutea, live/ dead foetuses and early/ late resorptions were recorded.

Results and discussion

Results: P0 (first parental generation)

Reproductive function / performance (P0)

Reproductive performance:
no effects observed
Description (incidence and severity):
Male fertility was not affected by the treatment

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Sex:
male
Basis for effect level:
reproductive performance
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: P1 (second parental generation)

Effect levels (P1)

Remarks on result:
not measured/tested

Results: F1 generation

Effect levels (F1)

Remarks on result:
not measured/tested

Results: F2 generation

Effect levels (F2)

Remarks on result:
not measured/tested

Overall reproductive toxicity

Reproductive effects observed:
no

Any other information on results incl. tables

For general toxicity results, please refer to IUCLID Section 7.5.1 (96 week study).

Applicant's summary and conclusion

Conclusions:
No treatment related effects on male fertility were observed up to the highest dose tested.