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Administrative data

Description of key information

No acute toxicity studies with calcium dibenzoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products as detailed in the table below.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Signs of acute oral or acute dermal toxicity are not expected for calcium dibenzoate, since the two moieties calcium and benzoate respectively benzoic acid have not shown signs of acute oral or acute dermal toxicity in in vivo testing (both LD50 > 2000 mg/kg bw). Under the assumption that the moieties of calcium dibenzoate show their toxicological profile individually upon dissolution, an acute toxicity estimates (ATE) for the acute oral and dermal (systemic) toxicity of calcium dibenzoate can be calculated using the equation given in regulation (EC) 1272/2008, Annex I, Section 3.1.3.6.1.

A study for acute toxicity via inhalation was not conducted with calcium dibenzoate, since it is produced and placed on the market in a form in which no inhalation hazard is anticipated, thus acute toxic effects are not likely to occur during manufacture and handling of that substance. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.

 

Justification for classification or non-classification

Based on in vivo oral and dermal LD50 data on the moieties, acute toxicity estimates for calcium dibenzoate have been calculated resulting in LD50 values > 2000 mg/kg bw. There are no indications on narcotic effects or respiratory irritation.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, Calcium dibenzoate does neither have to be classified and has no obligatory labelling requirement for acute oral or dermal toxicity nor for specific target organ toxicity after single exposure (STOT SE).

Calcium dibenzoate is not classified for acute inhalative toxicity because of lacking data.