Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Overall assessment

The available data on Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts comprise one Ames test, one HPRT test and one in-vivo MNT. Negative results were obtained in all available studies.

Since the Ames test comprised only four strains (TA97a, TA98, TA 100 and TA 102), missing the E-coli strain, the read-across approach was used to compensate for the uncertainty that may related to the missing the E-coli strain. No mutagenic effect was observed for the proposed source chemical in Ames test in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2.

 

Read-across Justification

Both the target and the source chemicals are so called " product by process", in which the given raw materials and the process conditions are considered to be comparable, and the resulting products are considered to be comparable as well. The target chemical is a reaction mass of pentapropylensuccinic anhydride with ethanolamine/sodiumhydroxyde/triethanolamine, whereas the source chemical is a reaction mass of linear alkenyl (c12/14) succinic anhydride with methoxypropypamine/triethanolamine. For both processes, the anhydride moiety undergoes ring opening reaction, resulting in the formation of mainly amide and ester.

The structural difference for the target and source chemical is given in that the alkly moiety of the target chemical is branched and saturated whereas that of the source chemical is linear and unsaturated. The given difference is not likely to be related to significantly deviating mutagenic potential.


Justification for selection of genetic toxicity endpoint
All available data are considered to be equally valid and relevant for the assessment of genotoxicity

Short description of key information:
No significant genotoxicity found

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All available data are indicative of low genotoxicity potential. No classification is warranted.