Reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study planned

Study period:

To be confirmed, due to delay of study.

Justification for type of information:

This information will be
submitted later based on ECHA communication/decision number TPE-D-2114496018-42-01/F

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: None available
- Available non-GLP studies: None available
- Historical human data: None available
- (Q)SAR: not sufficiently reliable for the prediction of repeated dose toxicity
- In vitro methods: not sufficiently reliable for the prediction of repeated dose toxicity
- Weight of evidence: no data are available
- Grouping and read-across: No read-across substance identified
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable

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 provision of a 90-day study is a standard REACH requirement. It is not possible to meet this data requirement through any non-testing methods or any Column 2 or Annex XI adaptations.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
90-day rat oral toxicity study (OECD 408) with the submission substance

Qualifier:

according to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)