Registration Dossier

Administrative data

sub-chronic toxicity: inhalation
Type of information:
experimental study planned
Study period:
To be agreed by 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 R.7a (October 2015, page 315), QSAR approaches are currently not well fitted-for-purpose for repeated dose toxicity and not all necessary aspects can be covered by a QSAR prediction.- In vitro methods:In vitro studies are not available on the test substance. Some in vitro test methods have been developped, however, according to ECHA guidance R.7a (October 2015, page 316), the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information.- 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:- Subchronic inhalation toxicity study in rat according to OECD guideline

Data source

Materials and methods

Test guideline
according to
OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
GLP compliance:
yes (incl. certificate)

Test material


Test animals


Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion