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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the results of two bacterial mutation assays and an in vitro chromosome aberration test in Chinese hamster lung fibroblasts, calcium chloride is considered not to have a genotoxic potential.

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

Additional information

Calcium chloride was negative in the bacterial mutation tests and the mammalian chromosome aberration test, showing no genotoxic potential for calcium chloride.

In addition, calcium chloride is already present in the tissue culture media of the in vitro test systems for genetic toxicity testing, and needed for normal function of the cells in culture.

Furthermore, the safety of the use of calcium chloride as a food additive was recently re-evaluated the EFSA Panel on Food Additives and Flavourings (Scientific opinion dated 6 June 2019, doi: 10.2903/j.efsa.2019.5751). The assessment confirmed that there is no concern with respect to genotoxicity.

Considering these aspects and taken into account that calcium chloride is a normal constituent of the body, no further genotoxicity testing is considered necessary.

Justification for classification or non-classification

Based on the negative results of the available in vitro tests, classification of calcium chloride is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.