Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Data on the human serum lithium ion concentration are provided in the Repeated Dose Toxicity Endpoint section.

Additional information

The lithium cation has been used extensively in human therapy for bipolar disease for example, in the form of lithiumsalts (e.g. carbonate, acetate, sulphate). As a result, considerable information is available on safe serum lithium ion concentrations over long periods of administration. Since the fatty acid anion of the lithium fatty acid salts is not considered to be a hazard, it is appropriate to use the human serum lithium ion concentration, converted to equivalent lithium fatty acid concentration, as the DNEL for the lithium salts of monocarboxylic acids C14 -C22 category.