Registration Dossier
Registration Dossier
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EC number: 231-179-5 | CAS number: 7440-70-2
Carcinogenicity
Administrative data
Description of key information
Metallic calcium used in industrial processes exhibits only risk through inhalation and dermal exposure when emitted from the process as oxidised and subsequently hydroxylated form, which will release hydroxyl ions as first contact effects. This first contact effect will have alkali effects of hydroxyl ion as the main irritant effect which prolonged may cause severe local alterations, including inflammation, metaplasia and hyperplasia which can ultimately lead to chronic inflammation and increased risk of development of cancer, therefore these are taken into account in the chemical safety assessment (see chapter 9 of CSR).
Long-term exposure of low levels of CaO-Ca(OH)2 dust particles are expected to cause sensory irritation and decrease of the lung function parameters. Sensory irritation is the primary effect and may be prevented by STEL-level of 1 mg/m3 of respirable dust as demonstrated by an acute inhalation toxicity study (See section 7.10.1), 8h-TWA OEL was recommended to set at 4 mg/m3. Prevention of first contact to external surfaces by appropriate risk management measures will minimize the risk of these long-term effects effectively, such as the prolonged exposure to alkali effects of hydroxyl ion (see chapter 9 of CSR).
Calcium (ionic form) is an essential mineral nutrient. For basic metabolism and evaluation of actions within the human body information of ionic form of calcium is used, which is the most prominent form of free calcium in the body. Calcium (Ca2+) is considered in the Human Health Section for relevant sections. As an essential mineral nutrient, distribution of calcium is actively regulated according to the body's requirements (see section 7.1 of IUCLID).
Key value for chemical safety assessment
Justification for classification or non-classification
Calcium (in its ionic form) is an essential element, which is tightly regulated by the human body within its different compartments. Calcium does not exhibit any properties which would raise a concern for carcinogenic properties. Classification for carcinogenicity is not warranted for Ca (metal form).
Additional information
Calcium levels are regulated tightly by homeostasis the human body therefore systemic effects are not foreseen. Calcium serves numerous biological, cellular and transmitter properties in the human body as an essential mineral. Ubiquitous presence in the environment as various calcium compounds and presence in human diet usually as ionized soluble forms withholds the necessity for further toxicity testing and risk analysis. Absorption and excretion, as well as homeostasis (intra- and extracellular), are tightly regulated by the human body. Therefore, calcium and its metabolites do not accumulate in the human body.
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