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Toxicological information

Carcinogenicity

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Description of key information

A lifetime study in rats exposed via the drinking water to 5 ppm aluminium potassium sulphate and a 20-month feeding study in mice on aluminium potassium sulphate administered via the diet at 1, 2.5, 5 and 10%.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
850 mg/kg bw/day
Study duration:
chronic
Species:
mouse
Quality of whole database:
Non-GLP, possibly non-OECD study but sufficient to determine an adequate conclusion.

Additional information

The available existing carcinogenicity studies are of low quality and are not adequate to conclude definitively on the potential carcinogenicity of aluminium sulphate. However, the available data do not indicate any concern with regard to potential carcinogenic activity in either rats or mice.

The available epidemiological studies provide limited evidence that certain exposures in the aluminium production industry are carcinogenic to humans, 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. Thus it was concluded that there is no evidence of increased cancer risk in non-occupationally exposed persons and indicates that aluminium itself is not a human carcinogen (IARC, Monograph 100F, 2012).

This view is also shared by the SCCS (2014) that stated that the available information does not support any concern regarding the potential carcinogenicity of aluminium compounds.

Both ATSDR and the WHO conclude that there are no indications for the carcinogenic potential of aluminium. From ATSDR 2008 (reported in the pesticide dossier by EFSA in 2009): The available data do not indicate that aluminium 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, Schroeder & Mitchener, 1975). Although these studies have limitations ranging from use of only one species to a single dose level and limited histological examinations, the evidence strongly suggests that aluminium is not carcinogenic, indicating the additional carcinogenicity testing is not warranted.

There are some publications in the literature that suggest a weak association between the cosmetic use of aluminium and breast cancer but definitive evidence is lacking. Also, the WHO and SCCS in 2014 have reviewed these data and conclude that the reported association is spurious and of no concern, consequently these documents have not been included as either short summaries or as robust summaries in this dossier.

In terms of genotoxicity potential a GLP, Klimisch Grade 1 in vivo micronucleus study on aluminium hydroxide has been used as a read-across study in support of three key in vitro studies. The RA in vivo study provided a negative conclusion for in vivo genotoxicity, which is in agreement with the Key in vitro study results. A total of six in vitro studies and 1 in vivo study have been included as weight of evdence or disregarded studies. Some of these studies provided negative results that were in agreement with the conclusions of the Key and RA studies. However, some of the studies also provided contrary positive conclusions. But none of the studies reported as positive were GLP and were classified as Klimisch grade 3 or 4. An expert review revealed that none of these studies was considered to be sufficiently reliable to add any significant weight against the strength of the Key and RA studies.

In agreement with the general scientific concensus, the available data on carcinogenicity provides sufficient evidence that aluminium sulphate is not carcinogenic to animals or to humans.


Justification for selection of carcinogenicity via oral route endpoint:
Klimisch grade 2 feeding study in mice. Full study report not available but the abstract indicates that it may be a reliable study.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for carcinogenicity according to the Regulation (EC) No. 1272/2008 including ATP3.

Self classification:

Based on the available data, the substance is :

- not classified for carcinogenicity according to the Regulation (EC) No. 1272/2008.

- not classified for carcinogenicity according to the Directive 67/548/EEC.