Aluminium sulphate

Endpoint summary

Additional information

Substance Aluminium sulphate was evaluated for its mutagenic and genotoxic potential in vitro and vivo.Overall the data summarised do not indicate any mutagenic or genotoxic potential of the substance.

In vitro Studies

Aluminium sulphate and both category sulfate were negative with and without metabolic activation in an Ames test performed according to OECD TG 471 (Wagner, 2001a/b); . Potassium sulfate and calcium sulfate were negative in an in vitro chromosomal aberration test with Chinese hamster ovary cells performed according to OECD TG 473 (Gudi, 2001a/b). Noin vitrogenotoxicity studies were available for potassium magnesium sulfate.

Aluminium sulphate was negative using Bacillus subtilis recombination assay (Kada et al. 1980, Kanematsu et al. 1980; Nishioka 1975

Aluminium sulphate was negative using "SOS Chromotest, a direct assay of induction of an SOS function in Escherichia coli K-12 to measure genotoxicity", Proc. Natl. Acad. Sci., 79, 5971 - 5975, Olivier, Ph. and Marzin, D. (1987)

ALTERNATIVE IN VITRO TESTS/ . In vitro experiments showed that the aluminum sulfate concentration needed to inhibit the enzyme activity was 1.0-5.0 mM (N = 3) in brain, 4.0-5.0 mM (N = 3) in liver and 0.0-5.0 mM (N = 3) in kidney. [Schetinger MR et al; Braz J Med Biol Res 32 (6): 761-766 (1999)]

In vivo Studies

An OECD TG 474 study was performed (micronucleusin vivo test, mouse) with the analogue substance calcium sulfate dihydrate, and reported that the substance tested negative in the micronucleus testin vivoup to the test concentration of 5000 mg/kg bw (SIAM 17, 2003).

ALTERNATIVE IN VIVO TESTS

In vivo treatment with aluminum sulfate did not inhibit ALA-D activity in the brain homogenate (Table 2). In liver, treatment with citrate and aluminum plus citrate increased ALA-D activity by 30-40% when compared to the control group. In kidney, ALA-D activity was inhibited 24% in the aluminum plus citrate group when compared to the control group. There was no difference between the control and citrate groups., Schetinger MR et al; Braz J Med Biol Res 32 (6): 761-766 (1999)

Short description of key information:
There are conclusive but not suffcient data for the classification of substance Aluminium sulphate with regard to mutagenicity/genetic toxicity.

Endpoint Conclusion: No adverse effect observed (negative)

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” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

 

 

Directive 67/548	Mutagenicity-Genetic Toxicity Muta. Cat. 1; R46 May cause heritable genetic damage. Muta. Cat. 2; R46 May cause heritable genetic damage. Muta. Cat. 3; R68 Possible risk of irreversible effects.
CLP	Germ cell mutagenicity Muta. 1A Muta. 1B Muta. 2 H340: May cause genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes 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 Mutagenicity-Genetic Toxicity