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EC number: 218-235-4
CAS number: 2090-05-3
No repeated dose toxicity study with calcium dibenzoate is
available, thus the repeated dose toxicity will be addressed with
existing data on the individual moieties calcium and benzoate.
According to the World Health Organization the recommended
lifelong daily calcium intake via diet or supplements is about 1000-1300
mg Ca. The tolerable upper intake level was determined by several
intervention studies with supplemental calcium, predominantly in the
form of calcium salts but also with milk products or with elemental
calcium from chicken egg-shell powder, which have been performed in
children, pregnant and lactating women and elderly men and women. They
were exposed to total calcium of up to 3000 mg Ca/day for up to 4 years.
Because none of these intervention studies showed adverse effects on
human health, the Scientific Committee on food proposed a tolerable
upper intake level (UL) of 2500 mg of calcium per day from all sources
for adults and pregnant/lactating women (Scientific Committee on Food-
Scientific Panel on Dietetic Products, Nutrition and Allergies, 2006).
Hence, no adverse effects are to be expected within a daily calcium
consumption of 2500 mg, constituting a human NOAEL.
No adequate studies with benzoic acid are available. Several
studies are available on the structural analogue sodium benzoate.
A short-term dietary study (10 days) with sodium benzoate in rats
and mice (Fujitani, 1993) showed a NOAEL of 905 mg/kg bw in rats and of
3571 mg/kg bw in mice. Effects included decreased body weight and
increased (rel) liver weights with enlarged (glossy) hepatocytes and
eosinophilic foci around the protal vein. In high dosed decreased kidney
weights were reported without histopathological changes. In addition, in
a 35 day study in rats with sodium benzoate (Sodemoto, 1979) animals at
the highest dose groups died. Symptoms in descendants were severe
decrease in body weight. Morphological effects were limited to atrophy
of the spleen and lymph nodes at 4 and 8% in diet. At the NOAEL 2% in
diet no morphological changes were reported. In a limited reported
90-day study on sodium benzoate in rats (Weil, 1953) a NOAEL of 2,620
mg/kg bw/day was established based on reduced body weight gain,
increased relative liver and kidney weights and pathological changes in
liver and kidneys at 6,290 mg/kg bw/day. The overall NOAEL for repeated
dose toxicity is based on a chronic toxicity study and is set at 1,000
mg/kg bw/day (Sodemoto, 1979).
For further information on the toxicity of benzoic acid, please
refer to the relevant sections in the IUCLID and CSR.
Since no repeated dose toxicity study is available specifically
for calcium dibenzoate, information on the individual moieties calcium
and benzoate respectively benzoic acid will be used for the hazard
assessment and when applicable for the risk characterisation of calcium
As the two moieties of calcium dibenzoate do not induce adverse effects
up to and including and even 3-fold above the OECD/EC Guidelines limit
dose for repeated oral dose toxicity testing, calcium dibenzoate in all
probability has also no potential for systemic toxicity leading to a
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 Specific target organ
toxicity by repeated exposure (STOT-RE).
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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