Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Three fully reliable studies (Covance Laboratories 1998/ KS K1/ Ames test; Bioservice Scientific Laboratories 2010/ K1 KS/ In vitro Mammalian Cell Gene Mutation Assay; Bioservice Scientific Laboratories 2010/ K1 KS/ In vitro Mammalian Chromosome Aberration Test) are available for 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. in vitro covering all mandatory endpoints of genetic toxicity in vivo.

All tests are negative therefore there is no indication of a mutagenic potential of the test item.


Short description of key information:
- genetic toxicity in vitro: negative, 3 studies (Covance Laboratories 1998/ KS K1/ Ames test; Bioservice Scientific Laboratories 2010/ K1 KS/ In vitro Mammalian Cell Gene Mutation Assay; Bioservice Scientific Laboratories 2010/ K1 KS/ In vitro Mammalian Chromosome Aberration Test)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above stated results a classification of 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. for genetic toxicity is not necessary according to CLP as implementation of UN GHS in the EU (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL).