Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: EOGRTS without extension of Cohort 1B, without Cohorts 2A and 2B and without Cohort 3
Type of information:
experimental study planned
Study period:
9 months

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EU Method B.56: Extended one-generation reproductive toxicity study
Principles of method if other than guideline:
1) Premating exposure duration: at least 2 weeks. Dose levels selection: 160, 400 and 1000 mg/kg/day
2) Without extension of the reproduction toxicity Cohort 1B
3) Without the developmental neurotoxicity Cohorts 2A and 2B
4) Without the developmental immunotoxicity Cohort 3.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion