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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 and bicarbonate no toxicity on mammalian reproduction is expected. No further study is considered necessary for this endpoint.

Effects on developmental toxicity

Description of key information

An oral developmental study 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.

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
340 mg/kg bw/day
Additional information

Sodium bicarbonate did not induce developmental effects when administered orally at the following doses: 580 mg/kg bw (mice), 340 mg/kg bw (rats) and 330 mg/kg bw (rabbits). Furthermore the substance will usually not reach the foetus when the exposure to sodium bicarbonate is sufficiently low, as it does not become systemically available.

[partly taken from OECD SIDS on sodium bicarbonate (2002), pg.18]

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.

Additional information

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