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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

In accordance with Section 1 of REACH Annex XI, testing does not appear scientifically necessary. None of the mutagenicity tests were performed according to guidelines. However, all the results were negative and more or less well documented. Furthermore, sodium bicarbonate is naturally present in cells and the structure does not indicate a genotoxic potential. Therefore, sodium bicarbonate is considered to be not genotoxic. Moreover, is the substance already present in the tissue culture media of the in vitro test systems for genetic toxicity testing, and needed for normal function of the cells in culture. Testing sodium bicarbonate in vitro will affect the cellular homeostasis due to osmolarity and/or pH of the culture medium which might give rise to a specific effects.

[partly taken from OECD SIDS on sodium bicarbonate (2002), pg. 17]

Short description of key information:
An Ames study using S. typhimurium, TA 92, 94, 98, 100, 1535, 1537 was negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information, the substance does not need to be classified according to CLP Regulation (EC) No 1272/2008.