Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
to be determined by 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 : Bis-(N,N-dimethylaminoethoxyethyl)-methylamine

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : A conmbined repeated dose toxicity study with reproduction/developmental toxicity screening test was performed with the test substance (according to OECD guideline 422; Edwards, 2019)
- Available non-GLP studies: No studies available
- Historical human data: No data available
- (Q)SAR: No (Q)SAR data can be used in a stand-alone approach to assess the developmental toxicity potential. According to ECHA guidance document R.7a (Dec 2016), QSAR approaches are currently not fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction
- In vitro methods: No in vitro method is available. Some in vitro test methods have been developed; however, according to ECHA guidance document R.7a (Dec 2016) these in vitro methods have not yet reached regulatory acceptance and do not provide stand alone, equivalent information
- Weight of evidence : No data is available which would allow a weight of evidence approach
- Grouping and read-across: No chemical grouping or read-across approach was identified

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:
- This test proposal is fully compliant with the ECHA guidance document R.7a (Dec 2016). It is not possible to waive the study based on column 2 adaptations of the REACH regulation.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- No additional information

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
Test material form:
liquid
Details on test material:
Appearance: clear liquid

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion