Sodium carbonate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

No data on reproduction / fertility toxicity are available. However, exposure to sodium carbonate will not result in increased systemic levels of sodium and carbonate due to the homeostatic regulation of both ions. Hence, no further studies are 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 NOAELs were above highest dose given.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Additional information

The developmental toxicity of sodium carbonate has been summarized already on page 16 of the OECD SIDS dossier (2002). Please find hereafter the text:

Aqueous solutions of sodium carbonate were administered daily via oral intubation to pregnant mice at doses ranging from 3.4 to 340 mg/kg bw during days 6-15 of gestation. The test substance did not affect implantation or the survival of dams and foetuses. Soft and skeletal tissue anomalies were noted in the experimental group, but the incidence of these findings did not differ from that of sham-treated controls. Similar negative results were reported for rats and rabbits for daily doses from 2.45 to 245 mg/kg bw and 1.79 to179 mg/kg bw, respectively (FDA, 1974). This study confirms in three species that there is no concern with regard to developmental toxicity (at least up to 179 mg/kg/d for rats), which supports the general consideration that the substance will usually not reach the foetus when exposed to sodium carbonate, as it does not become systemically available.

Summary and discussion of reproductive toxicity

The reproduction toxicity of sodium carbonate has been summarized already on page 16 of the OECD SIDS dossier (2002). Please find hereafter the text:

A reproduction toxicity test is not available for sodium carbonate. However, the substance will usually not reach the foetus or the male and female reproductive organs when exposed orally, dermally or by inhalation, as it does not become available systemically. As such, it is considered not useful to perform a reproduction study.

It is confirmed in three species that there is no concern with regard to developmental toxicity (at least up to 179 mg/kg/d for rats), which supports the general consideration that the substance will usually not reach the foetus when exposed to sodium carbonate, as it does not become systemically available.

Justification for classification or non-classification

Based on the available information, no classification for toxicity on reproduction is required in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.