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Toxicity to reproduction
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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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- whole body
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Tables 1, 2 and 3, 12-24 and 25
Appendix 1-6, 11-14, 21 and 24
Annex 3
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- <= 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: for offspring growth, based on the low birthweight and low bodyweight gain seen in litters where the females were dosed at 1000 mg/kg/day
- Remarks on result:
- other: Generation: F0 (migrated information)
Results: F1 generation
Details on results (F1)
Day 7 of age and sex ratio showed no adverse effect of parental treatment. Offspring
bodyweight on Day 1 of age and subsequent bodyweight gain up to Day 7 of age were similar
to control values for the litters of females receiving CI-166 at 100 and 300 mg/kg/day but
were significantly lower at 1000 mg/kg/day. Macroscopic examination of offspring killed at
scheduled termination on Day 7 of age revealed no abnormality.
See attachment:
Appendix 15-23
Tables 19-23 and Figure 5
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- <= 1 000 mg/kg bw/day
- Based on:
- dissolved
- Sex:
- male/female
- Basis for effect level:
- other: For reproductive performance in the CD rat following oral gavage administration in a standard screening test.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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