Registration Dossier

Administrative data

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Type of information:
experimental study planned
Justification for type of information:
A testing proposal is suggested on this endpoint as no available studies (neither GLP or non-GLP) nor historical human data are available to cover the information requirements for this tonnage level. Any potential grouping and read across has been evaluated. The use of (Q)SAR as well as in vitro methods are limited for this type of endpoint. There therefore is no possibility to fill the data gap by any other means than performing the proposed test.

Data source

Materials and methods

Test guideline
according to
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Justification for study design:
As in accordance with the data requirements in REACH annex X.

Test material

Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Polyol PX
- Molecular formula (if other than submission substance): Not documented
- Molecular weight (if other than submission substance): Not documented
- Smiles notation (if other than submission substance): Not documented
- InChl (if other than submission substance): Not documented
- Structural formula attached as image file (if other than submission substance): see Fig. Not documented
- Substance type: Not documented
- Physical state: Amber waxy solid
- Analytical purity: Not documented
- Impurities (identity and concentrations): Not documented
- Composition of test material, percentage of components: Not documented
- Isomers composition: Not documented
- Purity test date: Not documented
- Lot/batch No.: 391191549 (B)
- Expiration date of the lot/batch: 15th May 2014
- Radiochemical purity (if radiolabelling): 98.7%
- Specific activity (if radiolabelling): Not documented
- Locations of the label (if radiolabelling): Not documented
- Expiration date of radiochemical substance (if radiolabelling): Not documented
- Stability under test conditions: Not documented
- Storage condition of test material: Kept refrigerated in the dark.
- Other: pH of the formulation was pH 7.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion