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Bacterial Reverse Mutation assay:

In a reverse gene mutation assay in bacteria, performed according to the OECD No.471, Aluminium ammonium (bis)sulfate (83% as powder formulation) diluted in water was tested in S. typhimurium TA1535, TA1537, TA100, TA98 and TA102 in the presence and the absence of mammalian metabolic activation (S9 from Aroclor 1254-induced rats) using the plate incorporation method. Based on the results of cytotoxicity testing the five strains were tested and dose levels of 0.009, 0.019, 0.039, 0.078, 0.156, 0.312, 0.625, 1.25, 2.5 and 5.0 mg/plate in the first trial. A second trial was conducted in the presence of 10% S9 and test treatment rates of 0.051, 0.128, 0.32, 0.8 and 5.0mg/plate in triplicate. The positive controls induced the appropriate responses in the corresponding strains.

No induced revertant over background was observed in any strains of S. typhimurium up to the highest concentration of Aluminium ammonium (bis) sulphate. Under the test conditions, Aluminium ammonium (bis)sulfate did not show any mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium. This study is considered as acceptable as it satisfied the criteria of the OECD Guideline No. 471

 

In vitro Mammalian Chromosome Aberration test:

In an in vitro chromosome aberration test performed according to OECD guideline No 473 and in compliance with GLP, human primary lymphocyte cultures were exposed to Aluminium ammonium (bis)sulfate (> 99.94%) aqueous solutions. All concentrations were expressed in terms of the anhydrous form of the test article, using a conversion factor of 1.912. In the first experiment cells were exposed both in the presence (0, 40, 45, 50 and 75 µg/mL) and absence (0, 60, 70 and 75 µg/mL) of S-9 for 3 hours and sampled at 20 hours after the beginning of treatment. In the second experiment, cells were exposed continuously for 20 hours in the absence of S-9 (0, 60, 120 and 200 µg/mL) or 3 hours in the presence of S-9 (0, 50, 60 and 120 µg/mL). In Experiment 2, the lowest concentrations at which precipitate was observed at the end of the treatment incubation period in the absence and presence of S-9 appeared to be higher by comparison with those observed in the Range-Finder and Experiment 1. Furthermore, as there was no evidence of toxicity or post-treatment precipitate in the absence of S-9 in Experiment 2, a further 20+0 hour treatment in the absence of S-9 was performed in Experiment 3 (0, 50, 75 and 150 µg/mL). Positive controls induced the appropriate response. Chromosome aberrations were not induced over background at any tested concentrations in the absence and the presence of activation system in both experiments. Under the test conditions, Aluminium ammonium (bis) sulfate was not clastogenic in human lymphocytes exposed in vitro. This study is considered as acceptable and satisfies the requirement for the cytogenicity endpoint.

 

In vitro Mammalian Cell Gene Mutation test:

In an in vitro mammalian cell gene mutation test performed according to the OECD test guideline No. 476 and in compliance with GLP, Aluminium ammonium (bis) sulfate was assayed for its ability to induce mutation at the hprt locus (thio-6 -guanine resistance) in mouse lymphoma L5178Y cells. All concentrations were expressed in terms of the anhydrous form of the test article, using a conversion factor of 1.912. In the cytotoxicity range-finder experiment, 6 concentrations were tested in the absence and presence of S-9, ranging from 53.16 to 1700 µg/mL (limited by precipitation in culture medium). Upon addition of the test article to the cultures, precipitate was observed at the highest three concentrations tested in the absence and presence of S-9 (425 to 1700mg/mL). Following the 3 hour treatment incubation period, precipitate was observed at the highest five concentrations tested in the absence and presence of S-9 (106.3 to 1700mg/mL). The lowest concentration at which precipitate was observed at the end of the treatment incubation period in the absence and presence of S-9 was retained and higher concentrations were discarded. In Experiment 1 six concentrations, ranging from 10 to 80 µg/mL were tested in the absence of S-9 and seven concentrations ranging from 10 to 100 µg/mL were tested in the presence of S 9. In Experiment 2 four concentrations, ranging from 15 to 60 µg/mL were tested in the absence of S-9 and seven concentrations ranging from 15 to 90 µg/mL were tested in the presence of S 9. 

When tested up to precipitating concentrations in the absence and presence of S-9 in Experiments 1 and 2, no significant increases in mutant frequency were observed at any concentration analysed and there were no significant linear trends.

It may be noted that in the absence of S-9 in Experiment 2, both positive and negative control MF values were less than half of the historical positive control MF but both clearly exceeded the current historical vehicle control range. The sensitivity of the test system was considered to have been proven and the data in the absence of S-9 were considered to be acceptable and valid.

It is therefore conclude that Aluminium ammonium (bis) sulfate was not mutagenic when tested up to precipitating concentrations in the absence and presence of S-9.

Under the test conditions Aluminium ammonium (bis) sulfate is not mutagenic or clastogenic in vitro.


Short description of key information:
- Bacterial Reverse Mutation assay: not mutagenic (K, Reliability 1)
- In vitro Mammalian chromosome aberration test: not cytogenic (K, Reliability 1)
- In vitro Mammalian Cell Gene Mutation test: not mutagenic (K, Reliability 1)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available.

Self classification:

Aluminium ammonium (bis)sulphate l is not classified for genotoxicity according to the criteria of the Annex VI of the CLP regulation and according to the criteria of the Annex VI of the Directive 67/548/EC.