Registration Dossier
Registration Dossier
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EC number: 909-586-0 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
The current weight of evidence does not support an association between inhalation exposure to aluminium metal/aluminium oxide and cancers in the respiratory organs. The weight of evidence also does not support a systemic carcinogenic effect from exposure to aluminium metal and aluminium oxide.
Key value for chemical safety assessment
Justification for classification or non-classification
Based on the weight of evidence approach for carcinogenicity no classification is required for aluminium oxide according to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria.
Additional information
Systemic Effect
Human studies
Systemic carcinogenic effects from exposure specifically to aluminium have not been investigated in epidemiological studies. One study (Friesen et al., 2009; chapter 7.10.2) that investigated associations between alumina dust exposure and cancer incidence did not found evidence of an increase in risk of any cancer. The study was based on relatively few cases observed during a short follow-up period, and only crude adjustment for smoking was done. Although aluminium production has been classified by IARC as Group 1 (Carcinogenic to humans), the ATSDR (2008) states that “It is important to emphasize that the potential risk of cancer in the aluminium production industry is probably due to the presence of known carcinogens (e.g., PAHs) in the workplace and is not due to aluminium or its compounds.” The evidence from epidemiological studies does not support a carcinogenic effect.
Animal studies
Available animal studies do not provide evidence supporting a systemic carcinogenic effect of the target compounds.
Local (Respiratory organs)
Human studies
Local carcinogenic effects from exposure specifically to aluminium have not been investigated in epidemiological studies. One study that examined associations between exposure to alumina dust and cancer incidence (Friesen et al., 2009; chapter 7.10.2) provides no evidence of an increase in the risk of cancers in the respiratory organs. The study was based on relatively few cases observed during a short follow-up period, and only crude adjustment for smoking was done. The available evidence from epidemiological studies does not support a carcinogenic effect.
Animal studies
The studies by Gross et al. (1973) (Klimisch Score = 2) and Pigott et al. (1981) do not support a carcinogenic effect for aluminium metal and aluminium oxide.
One study of ultrafine Al2O3 particles administered by intratracheal instillation to rats was identified. Induction of lung tumours was observed. The results from this study lack relevance to actual human exposures due to the mode of administration and the high doses administered.
Due to the high doses applied and the high dose rate, rat-specific effects due to lung overload are likely.
The available evidence from animal studies does not support a carcinogenic effect specific to aluminium oxide and aluminium metal in humans.
In-vitro studies and Mechanism of Action
The results from in-vitro studies indicate that aluminium oxide has low cytotoxicity.
Overall, the current weight of evidence does not support an association between inhalation exposure to aluminium metal/aluminium oxide and cancers in the respiratory organs. The weight of evidence also does not support a systemic carcinogenic effect from exposure to aluminium metal and aluminium oxide.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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