Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The gene mutation tests are negative for the Na salt (CAS 1325 -54 -8, source chemicals): All available in vitro tests in genetic toxicity are GLP compliant and scored Klimisch 1 and 2 and all gave negative results.

The information recovered from lithium, leads to the conclusion that lithium is considered to have no genotoxic potential.

In the read-across study it is justified that the endpoint Genetic toxicity for target chemical CAS 1195028 -55 -7 can be assessed from the Na salt.

There is no need to carry out in vivo studies in genetic toxicity.

Justification for selection of genetic toxicity endpoint

Read-across from source chemical CAS 1325-54-89 is considered relevant and reliable.

Short description of key information:

The "in vitro" genetic toxicity testing  has been performed with source chemical CAS 1325-54-8. Information related to genotoxic properties of lithium has been included in the read-across approach study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Following the criteria as described in Directive 67/548/EEC and Annex 1of Regulation (EC) No. 1272/2008, and based on the available data, the substance is not classified for genetic toxicity