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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- whole body
- 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)
- 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.
- Reproductive effects observed:
- not specified
Reference
Tables 1, 2 and 3, 12-24 and 25
Appendix 1-6, 11-14, 21 and 24
Annex 3
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 on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- High quality study (Klimish: 1)
Justification for classification or non-classification
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