Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The study will be start in 2020 and the test will last one year.
Justification for type of information:
Public substance name: 2,6-dimethylheptan-2-ol
EC Number: 236-244-1
CAS Number: 13254-34-7

Date of considerations: 15 October 2019

Hazard endpoint for which vertebrate testing was proposed:

Developmental toxicity / teratogenicity

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information (instruction: please address all points below):

available GLP studies

No available GLP studies on the substance for the endpoint ‘Developmental toxicity / teratogenicity’.

available non-GLP studies

No available non-GLP studies on the substance for the endpoint ‘Developmental toxicity / teratogenicity’.

historical human data

No human data suggesting Developmental toxicity are available for this substance.

(Q)SAR

No validated (Q)SAR exists for this endpoint. There is no known mode of action for 2,6-dimethylheptan-2-ol causing Developmental toxicity effects.

in vitro methods

In accordance with ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a. With regards to studies for Developmental 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 labeling and/or risk assessment.

weight of evidence

No available ‘weight of evidence’ data on the substance for the endpoint ‘Developmental toxicity / teratogenicity’.

grouping and read-across

No data exists on analogous substances. It is the intention to use test data from 2,6-dimethylheptan-2-ol for further read-across to similar substances thus avoiding the need to perform further testing.

substance-tailored exposure driven testing [if applicable]

Not applicable

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 (instruction: free text):

Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Qualifier:
according to
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: CRL Sprague-Dawley CD® IGS rats

Results and discussion

Applicant's summary and conclusion