Registration Dossier
Registration Dossier
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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
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
