Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

-negative: Ames test, S.typhimurium TA98, TA 100, TA 102, TA 1535 and TA 1537 (met. act.: with and without) (OECD 471; GLP); reduction in number of revertants found in the negative control (exp.I, met. act.: with and without) was regarded as not biologically relevant due to lack of concomitant clearing of the background lawn, reduction in number of revertants down to 0.5 found in exp. II in strain TA 1535 at a concentration of 2500 µg/plate and in strain TA 1537 at concentrations of 316 and 1000 µg/plate (met. act.: without) was regarded as not biologically relevant due to lack of a dose-response relationship.

- negative: bacterial reverse mutation assay in E. coli strain SR250 (uvrB5) (met. act.: without) (similar to OECD 471, non-GLP); cytotoxicity: not reported.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A reverse gene mutation assay in bacteria according to OECD Test Guideline 471 is available for the test substance L-Asparagine. Also a reverse gene mutation assay in bacteria similar to OECD Test Guideline in E.coli is available as supporting data and there are published data that substantiate the notion that L-Asparagine is not associated with any genotoxic effect. In the study of Dyring et al. CHO cells were incubated with 10.2 and 5.8 mM L-Asparagine in order to determine the degree of metabolism in these cells. The increased ammonium content measured after incubation with L-Asparagine confirmed its metabolism. In another study of Costa et al. the induction of ornithine decarboxylase was determined in CHO cells incubated with 10 mM L-Asparagine. Although an increase of ODC activity was associated with an induction of cell proliferation, the treatment of CHO cells in this study did not result in an increased cell growth. In summary, the presented data provided evidence that L-Asparagine exhibits no genotoxic properties.

Justification for classification or non-classification

Based on the available, reliable and adequate data the substance does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) with respect to mutagenicity.