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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Carcinogenicity

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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 β€œIt 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.