Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-284-3 | CAS number: 1318-23-6
Carcinogenicity
Administrative data
Description of key information
Although limited in amount, the read-across approach within the weight of evidence does not support a systemic carcinogenic effect from exposure to Boehmite. The weight of evidence also does not support a local carcinogenic effect from exposure to Boehmite.
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 Boehmite according to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria.
Additional information
There are no studies available on carcinogenicity of Boehmite by the oral, inhalation and dermal route.
In terms of hazard assessment of toxic effects, available data on carcingenicity of other aluminium compounds were taken into account by read-across following a structural analogue approach, since the pathways leading to toxic outcomes are likely to be dominated by the chemistry and biochemistry of the aluminium ion (Al3+) (Krewski et al., 2007).
Systemic
Human studies
One human study investigating the association between bauxite dust exposure and cancer incidence (Friesen et al., 2009) found no evidence for a systemic carcinogenic effect due to the target aluminium compound. The study was based on relatively few cases observed during a short follow-up period, and only crude adjustment for smoking was done. Results from a small number of studies of the association between breast cancer and aluminium-containing antiperspirants are inconsistent (Namer et al., 2008).
Animal studies
Available animal studies do not provide evidence supporting a systemic carcinogenic effect of the target compounds.
Local (respiratory organs)
Human studies
No increase in risk of cancer in the respiratory organs was reported in one human study investigating the association between bauxite dust exposure and cancer incidence (Friesen et al., 2009). The study was based on relatively few cases observed during a short follow-up period, and only crude adjustment for smoking was done.
Animal studies
No animal studies addressing systemic carcinogenic effects of aluminium hydroxide have been identified. 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 Al2O3particles 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 availableevidence 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
No studies were identified for aluminium hydroxide. The results fromin-vitrostudies indicate that aluminium oxide has low cytotoxicity.
Overall
Although limited in amount, the weight of evidence does not support a systemic carcinogenic effect from exposure to aluminium hydroxide.
The weight of evidence also does not support a local carcinogenic effect from exposure to aluminium hydroxide.
Moreovoer, 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
