Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Short description of key information:
Both the in vitro and the in vivo genetic toxicity test indicated no evidence for a mutagenic activity. Furthermore NaOH is not expected to be systemically available in the body under normal handling and use conditions and for this reason additional testing is considered unnecessary.(EU RAR of sodium hydroxide, 2007, section, page 72). According to the REACH Regulation, further mutagenicity studies shall be considered in case of a positive result (column 2, Annexes VII, VIII). Therefore, further testing for mutagenicity is not relevant for NaOH.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative mutagenicity tests support no classification.