Registration Dossier

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Type of information:
experimental study planned
Study period:
Upon ECHA approval and final decision
Justification for type of information:
Not a CMR.
No widespread use, professional or consumer use.

Hazard endpoint for which vertebrate testing was proposed:
Reproductive toxicity (extended one-generation reproductive toxicity study) with the registered substance.

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information:

available GLP studies
No available GLP studies on the substances for the endpoint ‘reproductive toxicity’.

available non-GLP studies
No reliable non-GLP studies are avaialable for the endpoint ‘ reproductive toxicity’.

historical human data
No human data suggesting reproductive toxicity are available for this substance.

(Q)SAR
No validated (Q)SAR’s exist for this endpoint for this substance

in vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment , chapter R7a. With regards to in vitro studies for reproductive toxicity, the regulatory acceptance of these studies and approaches to replace the animal testing for reproductive toxicity has not been achieved as they do not provide equivalent information and thus, cannot be used alone for classification and labelling and/or risk assessment.

weight of evidence
No study exists for reproductive toxicity

grouping and read-across
No study exists for an analogous substance.

substance-tailored exposure driven testing [if applicable]
Based on existng exposure senario information on pivalic acid does not qualify for this exemption.

[approaches in addition to above [if applicable]
Not applicable

other reasons [if applicable]
Not applicable

Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Deviations:
no
Justification for study design:
Not a CMR.
No widespread use, professional or consumer use.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-64-1
- Substance type: white crystalline powder

Results and discussion

Applicant's summary and conclusion