3,3'-oxybis(ethyleneoxy)bis(propylamine)

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

within 18 month after receiving the final decision from ECHA

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
3,3’-Oxybis(ethyleneoxy)bis(propylamine)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
Available GLP studies are part of the registration dossier. There is a GLP-compliant OECD 422 study in rats after oral administration. However, this data do not fulfil the requirements of a full developmental toxicity/ teratogenicity study in rodents according to OECD TG 414.
- Available non-GLP studies
There are no non-GLP studies regarding the endpoint developmental toxicity/teratogenicity.
- Historical human data
Databases containing potential information for subchronic oral toxicity of the substance in published and internal data on the substance were searched and no contributing information was found.
- (Q)SAR
There are no QSAR models that allow a reliabe and adequate prediction of the potential of developmental toxicity/teratogenicity. Therefore, animal testing can not be replaced.
- In vitro methods
There are no in vitro methods that allow a reliabe and adequate prediction of the potential of developmental toxicity/teratogenicity.
- Weight of evidence
Considering the lack of in-vitro methods, QSAR models and subchronic repeated dose studies on the substance itself and potential analogues, a weight-of-evidence assessment is not possible.
- Grouping and read-across
Since none of potential candidates for read-across has been tested for developmental toxicity/teratogenicity in rodents according to OECD TG 414, read-across is not possible.
- 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:
Based on the existing data and hazard and use profile of the substance in question, it is not possible to apply specific adaptation possibilities listed in Annexes IX and X. Thus, a GLP-compliant developmental toxicity study in the rat via the oral route following OECD TG 414 is proposed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
A standard OECD 414 guideline study is proposed.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Version / remarks:

2018

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-oxybis(ethyleneoxy)bis(propylamine)

EC Number:

224-207-2

EC Name:

3,3'-oxybis(ethyleneoxy)bis(propylamine)

Cas Number:

4246-51-9

Molecular formula:

C10H24N2O3

IUPAC Name:

3,3'-[oxybis(ethane-2,1-diyloxy)]dipropan-1-amine

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage