Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames test was performed on five S typhimurium strains (TA 98, TA 100, TA1535, TA1537 and TA102) with or without metabolic activation according to OECD 471. The test item was diluted either in 0.9% NaCl in water ir in DMSO to final concentrations of 10, 20, 40, 60, 80 and 100%. No biologically relevant increase in revertant colonies were observed following treatment with polar or non-polar extracts of the test item at any concentration level neither in the presence or absence of metabolic activation. It can be deduced that the test item is not mutagenic for bacteria under the present experimental conditions.

In vitro mammalian cell micronucleus test was performed on V79 cells incubated with aluminium dross vitro i) with or without metabolic activation for 4 h ii) without metabolic activation for 24 h, according to OECD 487. The concentrations tested were 10, 15 and 20% of test material (in experiment I) and 15, 17.5 and 20% of test material (in experiment II). In both Experiment I and II, with or without metabolic activation there was no statistically significant increase in the number of micronucleated cells after treatment with the test item.Overall and under the experimental conditions reported, an extract of the test item ALUFLUX or Aluminium dross or gray Aluminium dross did not induce structural and/or numerical chromosomal damage in Chinese hamster V79 cells.

An extract of aluminum dross (Aluflux) was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y, according to OECD 476. The test item extract was tested at several concentrations. In experiment I 34% (without metabolic activation) and 25.0% (with metabolic activation) extract were selected as the highest concentrations. In experiment II 12.5% (without metabolic activation) and 24% extract (with metabolic activation) were selected as the highest concentrations. Experiment I without and with metabolic activation and experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as a 24 h long-term exposure assay. In experiment I (without and with metabolic activation) and in experiment II (with metabolic activation) no biologically relevant increase of mutants was found after treatment with the test item extracts (without and with metabolic activation). Additionally, in experiment I and II colony sizing showed no clastogenic effects induced by the test item extracts under the experimental conditions (without and with metabolic activation).

In conclusion, in the described mutagenicity test under the experimental conditions reported, the test item extract of ALUMINUM DROSS (ALUFLUX) is considered to be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells.


Short description of key information:
ALUFLUX or Aluminium dross or gray Aluminium dross is considered to be non-mutagenic for bacteria (OECD 471 bacteria reverse mutation test). ALUFLUX or Aluminium dross or gray Aluminium dross did not induce structural and/or numerical chromosomal damages (OECD 487 In vitro Micronucleous Test) in Chinese hamster V79 cells.
The test item extract of ALUMINUM DROSS (ALUFLUX) is considered to be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells, according to OECD 476
Therefore, an extract of ALUFLUX or Aluminium dross or gray Aluminium dross is considered to be non-mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The bacterial reverse mutation assay (Ames test) clearly showed ALUFLUX or Aluminium dross or gray Aluminium dross

to be non mutagenic. According to REACH, additional mutagenicity information is required. In a subsequent test – the in vitro Mammalian Micronucleus Assay no structural and/or numerical chromosomal damage have been induced. Therefore, Aluminum dross was considered to be non-mutagenic with respect to clastogenicity and/or aneugenicity.

Due to its physico-chemical characteristics the substance is neither systemically available nor bioavailable and can therefore not reach critical organs and tissues. Against this background, it can be concluded that the substance is highly unlikely to show in vivo mutagenic effects.

Taking into account the toxicological profile of the substance it can be concluded that the substance has no genetic toxicity potential and therefore no classification obligation according to the CLP Regulation.