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EC number: 218-235-4
CAS number: 2090-05-3
No genetic toxicity study with calcium dibenzoate is available,
thus the genetic toxicity will be addressed with existing data on the
individual moieties calcium and benzoate.
Considering the overall weight of evidence, such as in vitro data
and the crucial role of calcium in cellular processes such as
DNA-polymerase and cell cycle functioning as well as its role in
approved in vitro genotoxicity experiments show that calcium does not
exert any genotoxic or mutagenic effects to mammalian cells. Based on
the above existing information on the genotoxicity of calcium substances
and the weight of evidence information, calcium is considered as not
All available tests for gene mutations in bacteria did not show
any effects of the test substance with or without metabolic activation.
A poorly reported test in yeast (no metabolic activation) was positive,
but the validity of this result could not be checked (Piper, 1999). No
effects were reported after exposure of prophage containing E.coli
strains (Rossmann, 1991) or in an SOS/umu test in S. typhimurium
(Nakumara 1987). For cytogenetic effects, a chromosome aberration test
was ambiguous without metabolic activation (Ishidate, 1983). Several
other limited reported tests on sister chromatid exchange (without
metabolic activation) were negative. The test substance was positive in
a Comet assay (Esref, 2009), but it was clearly negative in an in vitro
micronucleus test (with and without metabolic activation) (Nesslany,
Additional studies were identified, but were not available for
review. The available results confirm that the test substance does not
induce gene mutations and is not likely to induce effects on the
A battery of in vivo tests were conducted with the structurally
related sodium benzoate and these all clearly indicated no cytogenetic
effects. These studies are considered to fully address and over-ride the
ambiguous results found in the in-vitro data set. The toxicokinetic
evaluation on sodium benzoate concluded that the substance will not be
taken up as the salt, but rather as the test substance entity (NOTOX
2010). Therefore it can be concluded that the results for the test
substance will not differ from those found in in vivo tests with sodium
Based on the clear negative in-vivo results, it is concluded that
the test substance does not induce genetic toxicity.
A range of in-vitro tests were negative with one ambiguous result.
These tests are confirmed as negative by no effects in a battery of in
vivo studies with the structural analogue sodium benzoate.
Calcium dibenzoate is not expected to be genotoxic, since the
moiety benzoic acid respectively benzoate has neither shown a gene
mutation potential in bacteria or mammalian cells nor a clastogenic
potential in in vitro and in vivo cytogenicity studies.
The use of calcium substances as essential supplements in cell culture
media used for genotoxicity tests demonstrates the absence of an
mutagenic potential of the moiety calcium in vitro. Taking further into
consideration the biochemical role of calcium in the human body and the
normal daily dietary requirements, an in vivo genotoxic effect of
calcium is also considered highly unlikely. 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 have a genotoxic
activity, calcium dibenzoate in all probability has also no potential to
induce genotoxic 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 germ cell mutagenicity.
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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