Registration Dossier

Administrative data

Description of key information

No data available, no testing justified, for further details please refer to "attached justification for data waiving".

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Acute oral toxicity studies as well as irritation studies, tests on mutagenicity and repeated dose toxicity indicate that the toxicological potential of L-asparagine is low. L-asparagine is a naturally, ubiquitously occurring amino acid which is an integral part of the intermediary metabolism. Hence, in vivo testing is scientifically not justified. Furthermore, due to its size and its minor capacity of reacting electrophilic it is considered to be out of the applicability domain of the validated and accepted in chemico/in vitro test systems currently available.

Based on available information, L-asparagine does not need to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) with respect to skin sensitisation.