1,1'-[oxybis(ethyleneoxy)]diethylene

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

After approval by ECHA

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE: 1,1'-[oxybis(ethyleneoxy)]diethylene
- Name of the substance on which testing is proposed to be carried out: 1,1'-[oxybis(ethyleneoxy)]diethylene (CAS 764-99-8, EC 212-133-3)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: There are no GLP studies available covering pre-natal developmental toxicity study information requirements.
- Available non-GLP studies: There are no non-GLP studies available covering pre-natal developmental toxicity information requirements.
- Historical human/control data: There are no historical human data available on pre-natal developmental toxicity study for the substance.
- (Q)SAR: At present there is no valid (Q)SAR model available to address pre-natal developmental toxicity (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance).
- In vitro methods: At present there are no valid in vitro methods available to address pre-natal developmental toxicity (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance)
- Weight of evidence: There are no data available which are sufficient for weight of evidence approach.
- Grouping and read-across: No substances or a category of substances are known which apply for read-across addressing pre-natal developmental toxicity study.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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:
In order to fulfill the information requirements stated in Annex IX, column 1 of REACH Regulation for substances manufactured or imported in quantities of 100 tpa or more, a pre-natal developmental toxicity study is proposed. No adaptations apply.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The proposed study will be performed in rats which will receive the test item via oral gavage according OECD TG 414.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-[oxybis(ethyleneoxy)]diethylene

EC Number:

212-133-3

EC Name:

1,1'-[oxybis(ethyleneoxy)]diethylene

Cas Number:

764-99-8

Molecular formula:

C8H14O3

IUPAC Name:

{2-[2-(ethenyloxy)ethoxy]ethoxy}ethene

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage