Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

In accordance with column 2 of REACH Annex VIII and IX, the repeated dose toxicity studies (required under section 8.6) are not needed if a substance undergoes immediate disintegration and there are sufficient data on the cleavage products. In aqueous solution calcium chloride immediately dissociates into the ions Ca2+and Cl-, which are both essential nutrients for humans and a daily intake of more than 1000 mg for each of the ions is recommended. As for healthy humans, the tolerable upper intake level for calcium is set at 2500 mg per day (equivalent to 6.9 g CaCl2per day)[1].For chloride, the reference nutrient intake is set at 2500 mg/day (equivalent to 3.9 g CaCl2per day)[2]. The estimated intake of calcium chloride in a form of food additives (160-345 mg/day) is considerably smaller than these values. Consistent with this, the establishment of an ADI for calcium chloride has not been deemed necessary by JECFA[3]. Therefore, repeated dose toxicity studies are considered (scientifically) not necessary.

There is one study for repeated dose oral toxicity in rats although the data presented in the study is not sufficient. The study shows no adverse effect of calcium chloride on rats fed 20 mg CaCl2/g diet (comparable to 1000 mg/kg bw/day or more) for 12 months.

[1] Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, 1999

[2] Department of Health, UK, 1991

[3] Joint FAO/WHO Expert Committee on Food Additives; 1974, 2001

Justification for classification or non-classification

As both calcium and chloride are essential nutrients for humanm and taking into account that the tolerable upper intake level for calcium is set at 2500 mg per day (equivalent to 6.9 g CaCl2 per day, classification is not warranted in accordance with Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.