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EC number: 218-235-4
CAS number: 2090-05-3
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.
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
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 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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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