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Carcinogenicity

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No valid data are available for aluminium chloride regarding carcinogenicity. However, three valid in vitro and one in vivo mutagenicity test, in part conducted with aluminium compounds with bioavailabilities comparable to that of anhydrous aluminium chloride (see section 7.1 of the IUCLID), gave no indication of a mutagenic potential. The available repeated dose studies give no indication that the test substance is able to induce hyperplasia or pre-neoplastic lesions.Therefore, it is concluded that the test substance does not suggest a specific alert for carcinogenicity, and a carcinogenicity study is not proposed.

The International Agency for Research on Cancer (IARC) has evaluated the carcinogenic risk of industrial exposures in aluminium production to humans (IARC Monograph 100F, 2012, corresponding section of the report is attached) and has concluded that there is sufficient evidence in humans for the carcinogenicity of occupational exposures during aluminium production, giving rise to cancer of the lung and bladder. However, the aluminium exposure was confounded by exposure to other agents, including polycyclic aromatic hydrocarbons, aromatic amines, nitro-compounds and asbestos, most of which are known carcinogens.

In a recent opinion regarding the safety of aluminium from dietary intake (The EFSA Journal, 2008, 754, 1 -34, corresponding section of the report is attached), the Panel of Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) of the European Food Safety Authority (EFSA) refers to the IARC evaluation and concludes that (quote) "There is no evidence of increased cancer risk in non-occupationally exposed persons and IARC did not implicate aluminium itself as a human carcinogen." The Panel also noted "the absence of epidemiological evidence for carcinogenicity of aluminium compounds used therapeutically, and the conclusion of IARC that aluminium itself is unlikely to be a human carcinogen, despite the observation of an association between inhalation exposure to aluminium dust and aluminium compounds during production/processing and cancer in workers." Overall, the Panel concluded that "aluminium is unlikely to be a human carcinogen at exposures relevant to dietary intake."

The Scientific Committee on Consumer Safety (SCCS) concurs with the conclusions drawn by the EFSA Panel in a recent opinion on the safety of aluminium in cosmetic products (SCCS/1525/14, corresponding section of the report is attached).

The ATSDR (Agency for Toxic Substances and Disease Registry, U.S. Department of Health and Human Services) comes to the conclusion that the available data give no indication that aluminium is a potential carcinogen. In its evaluation document "Toxicological Profile for Aluminum" (2008), the ATSDR states: "The available data do not indicate that aluminum is a potential carcinogen. It has not been shown to be carcinogenic in epidemiological studies in humans, nor in animal studies using inhalation, oral, and other exposure routes (Oneda et al. 1994; Ondreicka et al. 1966; Pigott et al. 1981; Schroeder and Mitchener 1975a, 1975b). Although these studies have limitations ranging from use of only one species to a single exposure level and limited histological examinations, the evidence strongly suggests that aluminum is not carcinogenic, indicating that additional carcinogenicity testing is not warranted at this time."