Registration Dossier

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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Based on data in multiple mutagenicity tests on a variety of lithium salts it is concluded that lithium lacks mutagenicity.
Consequently, lithium hydroxide (respectively lithium hydroxide monohydrate) 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 hydroxide (respectively lithium hydroxide monohydrate) has not to be considered as a genotoxic or clastogenic substance.