Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-633-8
CAS number: 144-55-8
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.
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,
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).
Based on the available information, the substance does not need to be
classified according to CLP Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Esta web utiliza cookies para mejorar su experiencia de navegación en nuestros sitios web.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again