Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No data on reproduction toxicity were available. However, based on the normal physiological role of sodium, carbonate and bicarbonate no toxicity on mammalian reproduction is expected. No further study is considered necessary for this endpoint.

Sodium bicarbonate and sodium carbonate did not induce developmental effects when administered orally to three different mammalian species (rat, mouse and rabbit). Furthermore the substances will usually not reach the foetus when the exposure is sufficiently low, as it does not become systemically available. [partly taken from OECD SIDS on sodium bicarbonate (2002), pg.18

Short description of key information:
An oral developmental study for sodium carbonate and sodium bicarbonate was performed in 3 species (mouse, rat and rabbit). In all three species no maternal or teratogenic effects were noted, and NOAEL 's were above highest dose given.

Effects on developmental toxicity

Description of key information
Based on the available information, the substance does not need to be classifiedaccording to EU Directive 67/548/EECor CLP Regulation (EC) No 1272/2008.

Justification for classification or non-classification