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Description of key information

A number of studies are available in which the toxicity of sodium hydrogencarbonate following repeated exposure is examined. Nevertheless, none of these studies is performed in line with recent guidelines, nor was it possible to derive a NOAEL from the data. Nevertheless, in accordance with section 1 of REACH Annex XI, a chronic repeated dose toxicity study on sodium hydrogencarbonate is considered scientifically unjustified because sodium and hydrogencarbonate ions are ubiquitous in living organisms, and both have important roles in the physiology of normal cell functioning.

Key value for chemical safety assessment

Additional information

A summary on the repeated dose toxicity of sodium bicarbonate has been described already on page 16 and 17 of the OECD SIDS dossier (2002). Please find hereafter the text:

Adequate repeated dose toxicity studies are not available and therefore a NOAEL or LOAEL has not been determined. None of the repeated dose studies were done in the rat, the species recommended, and the relevance of the results for humans is limited due to the way in which the studies were done. However, in humans there is a long history of sodium bicarbonate use as an antacid in doses up to 4 g without adverse effects of long-term use, although it is recommended not to use high doses of pure sodium bicarbonate instead of antacids (Gosselin, 1976; McEvoy, 1994).

 

Sodium bicarbonate is already recognised as ‘GRAS’ in food with no other limitation than current good manufacturing practice (FDA, 1983). In addition, sodium bicarbonate is an important extracellular buffer in vertebrates and is therefore readily regulated in the body. Therefore, additional testing for repeated dose toxicity is not deemed necessary.

Furthermore sodium bicarbonate is used as a food additive and also as a feed material in the EU which confirms that the substance has a low repeated dose toxicity. The Joint FAO/WHO Expert Committee on Food Additives considered it not necessary to derive an Acceptable Daily Intake (ADI) for the food additive sodium bicarbonate (JECFA, 1965).

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.

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