Lithium bis(trifluoromethylsulfonyl)imide

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro Bacterial mutagenicity (Ames Test)

Four reliable bacterial reverse mutation assays are available. Two studies were selected as a key study, of reliability 1 according to Klimisch (Haddouk, 2002a and Jones, 1992) and the others were selected as supporting studies, of reliability 2 (Van Delft, 1997 and Lawlor, 1991).

In the two key studies according to OECD Guideline 471, TFSILi has been evaluated using six strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100, TA1538 and TA102) and one strain of Escherichia coli (WP2uvrA). TFSILi did not show any potential of mutagenicity with or without metabolic activation in the available bacterial reverse mutation assays.

In vitro Clastogenic potential

Three chromosome aberration studies of reliability 1 are available and were selected as key studies (Haddouk, 2002b; Jones, 1993 2 studies). A clastogenic potential was indicated in an in vitro chromosome aberration test in Chinese hamster lung (V79) cells both in the presence and absence of metabolic activation and at test concentrations of at least 652 µg/ml (Jones, 1993b). In contrast, there was no indication of a clastogenic potential in two other studies (Haddouk, 2002b and Jones, 1993a) in which TFSILi was tested in a chromosome aberration test (OECD guideline n°473) with cultured human lymphocytes, with and without metabolic activation. Since the clastogenic effects observed in CHL cells were not confirmed in the 2 studies with human lymphocytes, the first study was considered as false positive.

In vitro Mammalian cell mutagenicity

A GLP compliant study on mammalian cells of reliability 1 is available and was selected as key study (Brient, 2015). TFSILi was tested in the L5178 TK +/- mouse lymphoma gene mutation assay (OECD guideline n°476) with and without metabolic activation. In this test, TFSILi did not show mutagenic activity with or without metabolic activation.

All the in vitro tests showed negative results except for the clastogenic effect on CHL cells in the chromosome aberration test. As the two other tests on clastogenic effect with human lymphocytes showed negative results and taking into account the negative results of the four bacterial reverse mutation assays and the in-vitro Mammalian cell mutagenicity assay, it is concluded that bis trifluoromethanesulfonimide lithium is not to be considered as mutagenic. Further testing of in vivo genetic toxicity is not considered necessary.

Justification for classification or non-classification

Based on the available in vitro genotoxicity studies, the test substance does not need to be classified for genotoxicity according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008