Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Adequacy of study:
other information
Study period:
From 26 JUL 2000 to 02 OCT 2000
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Administration / exposure

Duration of treatment / exposure:
F0-males:
- for 2 weeks prior to mating, throughout mating and after mating at least until the minimum total dosing period of 28 days had been completed
F0-females:
2 weeks prior to mating, throughout mating, and pregnancy and at least up to, and including the day before sacrifice
Frequency of treatment:
once daily

Duration of test:
Start treatment: 2000-08-21
Start terminal procedures: F0-males: 2000-09-19; F0-females: 2000-10-02
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 200, 1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Examinations

Statistics:
- Dunnett-test
- Steel-test
- exact Fisher-test





Indices:
Reproductive indices:
- percentage mating: (number of females mated)/(number of females paired) * 100
- fertility index: (number of animals pregnant or siring a litter)/(number of females paired) * 100
- conception index: (number of animals pregnant)/(number of females mated) *100
- gestation index: (number bearing live pups)/(number pregnant) * 100


Offspring viability indices:
- percentage live males at first litter check: (number of live male pups)/(number of live pups) * 100
- percentage live females at first litter check: (number of live female pups)/(number of live pups) * 100
- viability index: (number of live pups on day 4 P.P.)/(number of live pups born alive) * 100

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Effect level:
1 000 mg/kg bw/day (actual dose received)

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion