Registration Dossier

Administrative data

Description of key information

The combined oral LD50 for male and female rats, determined in a GLP-compliant guideline study, was 2301 mg/kg bw. The dermal LD50 for rabbits was above 5000 mg/kg bw. No reliable animal data on acute inhalation toxicity are available; however, human data suggest that calcium chloride is not acutely toxic by inhalation. A non-reliable acute toxicity study with rats reported signs of respiratory tract irritation at 40 and 160 mg/m3.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 301 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

The acute toxicity of calcium chloride is low.The combined oral LD50value in the GLP-compliant study with rat was 2301 mg/kg bw (Toxicological Laboratories Limited, 1987). The dermal LD50 value in the study with rabbits was above 2000 mg/kg bw (Carreon et al., 1981a).No reliable animal data are available on the acute inhalation toxicity; however, in accordance with Column 2 of REACH Annex VIII, the study does not need to be conducted, as sufficient data are available on two other routes of exposure, oral and dermal. In the acute inhalation toxicity study with rats of limited reliability, signs of irritation of the respiratory tract were described at both exposure levels (40 and 160 mg/m3), suggesting that inhalation of calcium chloride can cause an irritation of the respiratory tract. As no deaths were observed, LC50 was established to exceed 160 mg/m3.

In addition, Vinnikov et al. (1962) reported treating tuberculosis patients with aerosol inhalations of 2 -5% aqueous calcium chloride.The number of inhalations varied from below 10 (24 patients), till over 30 (2 patients).Several patients reported irritation of mucos membranes of pharinx and throat and unpleasant sensation in mouth already after the first inhalations. However, the frequency of such cases was described as minor by the authors. Overall calcium chloride inhalations were said to have beneficiary effects on disease symptoms (improved quality of spatum, decreased amounts of spatum, improved ease of spatum expellance, decreased frequency of coughing). These data are considered to prove that calcium chloride is not acutely toxic by inhalation.

Justification for classification or non-classification

The combined oral LD50 value in the GLP-compliant study with rat was 2301 mg/kg bw. The dermal LD50 value in the study with rabbits was above 5000 mg/kg bw. These values are above the cut-off limit of 2000 mg/kg bw, established by EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, and therefore classification is not warranted.