Registration Dossier

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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