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Description of key information

Calcium lactate fully dissociates into Ca2+ ions and lactate- in aqueous solutions and/or under physilogical conditions. The toxicological effects of lactate can be understood in terms of the toxicological effects of lactic acid and calcium chloride. 
Despite being irritating to abraded rabbit skin, lactic acid is practically non-toxic by the oral, inhalation and dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Higher than 2000 mg/kg bw.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:

Higher than 2000 mg/kg bw.

Additional information

Calcium lactate fully dissociates into Ca2+ ions and lactate- in aqueous solutions and/or under physilogical conditions. The systemic toxicological effects of calcium lactate can be understood in terms of the toxicological effects of lactic acid and calcium chloride (see read across document).

Lactic acid is a ubiquitous and essential biological molecule. It is, as is to be expected, practically non-toxic by all routes of exposure. Dermal exposure to 2000 mg/kg bw induced severe irritation, but no mortality. Oral administration of doses of 3500 mg/kg bw induce mortality, and lower doses induce clear signs of toxicity. All toxicity signs clearly point to (acid) irritation as the main or only mode of action. At 7400 mg/m3 lactic acid in air, one out of 5 female rats died in a 4 hour inhalation study. All symptoms observed in dead and surviving animals suggest (acid) irritation as the main or only mode of action. Nonetheless, local effects such as irritation are not relevant for the lactate, and are caused due to the low pH; therefore, they are not relevant for calcium lactate.

 

The acute toxicity of calcium chloride is rather low.The combined oral LD50 value 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.

Inhalation is not considered as the most relevant exposure route for calcium lactate. Since data are available for the oral and dermal route, such a study does not need to be conducted.

 


Justification for selection of acute toxicity – oral endpoint
Calcium lactate fully dissociates into Ca2+ ions and lactate- in aqueous solutions and/or under physilogical conditions. The toxicological effects of calcium lactate can be understood in terms of the toxicological effects of lactic acid and calcium chloride. Calcium chloride and lactic acid are both practically non-toxic with oral LD50s higher than 2000 mg/m3.

Justification for selection of acute toxicity – dermal endpoint
Calcium lactate fully dissociates into Ca2+ ions and lactate- in aqueous solutions and/or under physilogical conditions. The toxicological effects of calcium lactate can be understood in terms of the toxicological effects of lactic acid and calcium chloride. Calcium chloride and lactic acid are both practically non-toxic with dermal LD50s higher than 2000 mg/kg bw

Justification for classification or non-classification

Calcium lactate is not acutely toxic. No classification required.