Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methylcellulose
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
Daily
Details on study schedule:
males and females - 2 weeks prior to the mating period and during the mating period,
pregnant females - during pregnancy and till the 3rd day pf lactation,
males - after mating period - totally for 28 days,
nonpregnant females (mated females without parturition) - for 25 days after the confirmed mating.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
160 mg/kg bw
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
400 mg/kg bw
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
12
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
excrements coloured by the test substance
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Sex:
male/female

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

The growth (body weight and food consumption) and clinical status of parental animals were not adversely influenced by the test substance treatment, so that no toxic effect of the test substance to parental animals was observed.

Biometry and structure of reproductive organs of parental males and females and quality of sperms of parental males were not adverselyinfluenced by the test substance treatment.

Reproductive performance - ability of male and female animals to succesfully mate and produce viable offspring was unaffected by th e test substance treatment.

Development of pups was not changed in treatment groups.