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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
Review article. Several kinds of genotoxicity indicated.
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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:
review article or handbook
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Published data. No guideline indicated.
Type of assay:
other: Review article. Several kinds of genotoxicity studies indicated.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium hydroxide
EC Number:
215-183-4
EC Name:
Lithium hydroxide
Cas Number:
1310-65-2
Molecular formula:
LiOH
IUPAC Name:
Lithium hydroxide

Results and discussion

Applicant's summary and conclusion

Conclusions:
Based on data of multiple mutagenicity tests with a variety of lithium salts it is concluded that lithium salts lack mutagenicity.
Consequently, lithium, being the toxicological relevant moiety has not to be considered as a genotoxic or clastogenic substance.
Executive summary:

The authors summarized the results of in vitro and in vivo mutagenicity , DNA damage , CA and SCE tests with various lithium salts. Several studies reported 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 genotoxicity observed might be a secondary effect of increased cell survival caused by lithium’s inhibition of GSK3.

Based on the conclusion of the authors, lithium hydroxide (formed following contact of lithium with aqueous solutions) and thereby lithium (in a read across approach) could be considered not genotoxic or clastogenic substance.