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Toxicological information

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Key value for chemical safety assessment

Effects on fertility

Description of key information

No toxicity data on adverse effects on sexual function and fertility with calcium dibenzoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties calcium and benzoate.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Calcium

Calcium plays an essential role in male and female fertility. It is involved in normal spermatogenesis, sperm maturation and sperm motility as well as in maintaining optimal conditions for acrosome reaction, which is necessary for the fertilization process. All these processes indicate the pivotal role of calcium in human fertility in men and women. It is therefore concluded that calcium itself does not show any effects on the impairment of male or female fertility. Additional studies in animals are not believed to contribute to the existing evidence for a lack of reproductive toxicity of calcium. Thus, further studies in animals are considered to be scientifically unjustified

 

Benzoic acid

In a 4-generation rat study (Kieckebusch 1970), no effects on fertility, reproductive performance and offspring were

reported at up to and including 1% the test substance in feed equivalent to 500 mg/kg bw/d (highest dose tested).

 

 

Calcium dibenzoate

Calcium dibenzoate is not expected to impair fertility, since the two moieties calcium and benzoic acid respectively benzoate have not shown adverse effects on fertility. Further testing is not required. 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

As the two moieties of calcium dibenzoate do not impair sexual function, fertility or the development of the offspring, calcium dibenzoate in all probability does also not have reproductive toxic effects.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, calcium dibenzoate does not have to be classified and has no obligatory labelling requirement for reproductive toxicity.

Additional information