Lithium carbonate

Genetic toxicity: in vivo

Administrative data

Endpoint:

genetic toxicity in vivo, other

Remarks:

Summary on several different tests

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Some of the summarized reports did not contain the complete data for a sufficient evaluation, e.g. frequency of various types of aberrations was not specified and the significance of the increases were not given in the study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Lithium carbonate

EC Number:

209-062-5

EC Name:

Lithium carbonate

Cas Number:

554-13-2

Molecular formula:

CH2O3.2Li

IUPAC Name:

dilithium carbonate

Applicant's summary and conclusion

Conclusions:

Based on data in multiple mutagenicity tests on a variety of lithium salts it is concluded that lithium lacks mutagenicity.
Consequently, Lithium carbonate has not to be considered as a genotoxic or clastogenic substance.

Executive summary:

The authors summarized that various Lithium salts have been tested in vitro and in vivo for mutagenicity, DNA damage, CA and SCE. Several studies report genotoxic effects of various lithium compounds at high doses (equivalent to therapeutic doses or higher), whereas many other studies have failed to demonstrate an effect. The Nordic Expert Group stated, that considering the chemical properties of the lithium compounds it is unlikely that they act as direct mutagens. A possible explanation to the apparent genotoxicity they see in a secondary effect of increased cell survival caused by lithium’s inhibition of GSK3 Consequently, Lithium carbonate has not to be considered as a genotoxic or clastogenic substance.