Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
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:
Developmental toxicity (oral rat 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 developmental GLP studies on the substances for the endpoint ‘developmental toxicity’.

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

historical human data
No human data suggesting developmental 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 developmental toxicity, the regulatory acceptance of these studies and approaches to replace the animal testing for developmental 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 developmental 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 414 (Prenatal Developmental Toxicity Study)
Deviations:
no

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

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion