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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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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:
2012
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

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

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)

See attachment:
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)

The mean number of implantations, the live litter size on Day 1, the offspring survival up to
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