Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Endpoint Conclusion:

Justification for classification or non-classification

There is no information available for trilithium orthophosphate concerning genotoxicity.

Concerning this endpoint, the lithium ion is considered to be the main toxophore, as phosphate ions are widely distributed throughout the organism (e.g. as structural material of bone and teeth and in form of adenosine phosphates ADP and ATP).

In a reverse mutation assay using Bacillus subtilis (rec assay) Lithium chloride was tested negative (Kanematsu et al.; Mutation Research 77: 109-116). 

There is one study entry for Lithium hydroxide publicly available on the ECHA (European Chemicals Agency) homepage (disseminated dossier for lithium hydroxide), where the induction of chromosome aberrations in culture peripheral human lymphocytes was investigated. Under the conditions of this study, Lithium hydroxide was found to be non-clastogenic.

Léonard et al. reviewed the mutagenic potential of several lithium compounds (Lithium chloride, Lithium carbonate, Lithium acetate, Lithium sulphate). They concluded that lithium compounds have no significant clastogenic potential and equivocal mutagenic activity.

For Trilithium citrate, negative effects were reported from an Ames test with Salmonella typhimurium (34 µmol per plate), in the host-mediated assay with E.coli and in mice (4 mmol/kg i.p.).

The authors mentioned that high concentrations of Lithium carbonate (3 mg/ml) slightly inhibited DNA synthesis in V79 Chinese hamster cells and in human EUE fibroblasts. The effect is described to be lessened by the addition of S9 fraction.

There is also some information given concerning the experiences with Lithium-treated patients (as Lithium compounds are widely used in psychotherapy for the treatment of bipolar disorders). All the experiments failed to observe cytogenetic changes in peripheral blood cells of patients treated with Lithium salts (Mutation Research 339; 131-137; 1995).

Based on a weight of evidence approach, trilithium orthophosphate is not classified for genetic toxicity in accordance to Directive 67/548/EEC and in accordance to EU CLP (Regulation (EC) No. 1272/2008) and UN GHS.