Registration Dossier

Administrative data

developmental toxicity
Type of information:
experimental study planned
Study period:
To be agreed with ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALSNON-CONFIDENTIAL NAME OF SUBSTANCE:- Reaction products of polyaminoalkane and substituted octadecanoic acidCONSIDERATIONS 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 non-GLP studies: none- Historical human data: none- (Q)SAR: According to ECHA guidance, QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction. (ECHA guidance R.7a, October 2015, page 382).- In vitro methods:In vitro studies are not available on the test substance. Some in vitro test methods have been developped, however, according to Chapter R 7a Version 4.1, the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information (ECHA guidance R.7a, October 2015, page 381).- Weight of evidence: No data is available which allow a weight of evidence approach.- Grouping and read-across: Actually, no information is available from comparable substances.- Substance-tailored exposure driven testing: not applicable- Approaches in addition to above : not applicable- Other reasons: not applicableCONSIDERATIONS 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:- Test proposal is fully compliant with ECHA guidance ( R 7.a-Octobre 2015, page 373). No specific adaptation possibilities of Annexes VI to X (and column 2 thereof) are applicable.FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:- Developmental toxicity in rat by oral route according to OECD guideline

Data source

Materials and methods

Test guideline
according to
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. certificate)

Test material


Test animals


Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion