Aluminium sulphate

Carcinogenicity

Description of key information

Evidence for Carcinogenicity: 
A4: Not classifiable as a human carcinogen. /Aluminum metal and insoluble compounds/ 
[American Conference of Governmental Industrial Hygienists TLVs and BEIs. Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Cincinnati, OH, 2008, p. 11]
 
There are conclusive but not suffcient data for the classification of substance Aluminium sulphate with regard to carcinogenicity.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion

Dose descriptor:

NOAEL

850 mg/kg bw/day

Carcinogenicity: via inhalation route

Endpoint conclusion

Dose descriptor:

NOAEC

6.1 mg/m³

Carcinogenicity: via dermal route

Endpoint conclusion

Dose descriptor:

NOAEL

21.3 mg/kg bw/day

Justification for classification or non-classification

Based on the hazard assessmentof aluminium sulphate in section 2.1 and 2.2.in IUCLID 5.2., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” and according to the criteria described in Directive 67/548 and in the CLP Regulation:

 

 

Directive 67/548	Carcinogenicity Carc. Cat. 1; R45 May cause cancer. Carc. Cat. 1; R49 May cause cancer by inhalation. Carc. Cat. 2; R45 May cause cancer. Carc. Cat. 2; R49 May cause cancer by inhalation. Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.
CLP	Carcinogenicity Carc. 1A Carc. 1B Carc. 2 H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.

 

It is concluded that the substance aluminium sulphate does not meet the criteria to be classified for human health hazards for Carcinogenicity.

 

Additional information

The literature concerning oral exposure bioassays is very limited. An increase in gross tumours was reported in male rats and female mice in a one-dose study but few study details were reported (Schroeder and Mitchener 1975a, 1975b, as reported in ATSDR 2006). Two other studies reported no increased incidence of tumours in rats and mice exposed orally to aluminum compounds (Hackenberg 1972; Oneda et al. 1994).

No increased tumour incidence was observed in rats following inhalation of alumina fibres at concentrations of up to 2.45 mg/m3 ( Pigott GH et al.1981, Krewski et al. 2007).

The International Agency for Research on Cancer did not classify specific aluminum compounds for carcinogenicity, but classified the exposure circumstances of aluminum production as carcinogenic to humans (Group 1) (IARC 1987).

For dermal exposure we taken that:

-the average weight of rats is 250g (200-300g),

-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg

corrected dermal NOAEL= oral NOAEL

850 mg/kg bw/day * 0.025 kg =

NOAELrat 21.3 mg/kg bw/day

 

 

Carcinogenicity: via oral route (target organ): other: all gross lesions and masses

Carcinogenicity: via inhalation route (target organ): respiratory: lung

Carcinogenicity: via dermal route (target organ): other: all gross lesions and masses