Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:

- Available GLP studies: No adequate and reliable GLP studies addressing reproductive toxicity are available with the test substance or similar substance. A sub-chronic repeated dose oral toxicity study in the rat conducted according to OECD test guideline 408 has been proposed. If this study shows classification would be required for reproductive toxicity, then further testing to address this endpoint would not be necessary. A stepwise testing approach is therefore proposed.

- Available non-GLP studies: No adequate and reliable non-GLP studies addressing reproductive toxicity are available with the test substance or similar substance

- Historical human data: No data are available

- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of reproductive toxicity.

- In vitro methods: No validated in vitro methods to assess reproductive toxicity are available to date.

- Weight of evidence: There are no data to assess the reproductive toxicity of the test substance; a weight of evidence approach is therefore not appropriate.

- Grouping and read-across: There are no similar substances which are considered to be acceptable for read-across;

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The generation of data to address the toxicity to reproduction is a standard requirement under REACH at this tonnage band and cannot be adapted for this substance based on any Column 2 or Annex XI adaptions.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- A study is proposed to be conducted with Reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol according to OECD test guideline 414 in the rat via the oral route.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

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

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion