Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The genetic toxicity of lipase has been investigated in the Ames assay, in the in vitro chromosome aberration assay, in the in vitro mammalian cell test looking at the induction of micronuclei and in the mouse lymphoma assay. All tests have been performed according to OECD and EC guidelines, and in compliance with GLP. No evidence for genetic toxicity was observed and thus it can be concluded that lipase is not mutagenic and does not induce chromosome aberration in the present test systems.

The safety of the production strain was further fully documented to belong to a safe strain lineage (Pariza and Johnson, 2001) and the enzyme test material was well characterized.

 

Reference:

Pariza, M. W., and Johnson, E. A. (2001). Evaluating the Safety of Microbial Enzyme Preparations Used in Food Processing: Update for a New Century. Regulatory Toxicology and Pharmacology, 33: 173-186.

Short description of key information:
No mutagenic activity of lipase was observed in the Ames assay, the in vitro micronucleus test, the in vitro human lymphocyte chromosome aberration test or in the mouse lymphoma assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Due to the lack of genetic toxicity, lipase should not be classified.