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Administrative data

Key value for chemical safety assessment

Additional information

Ames test:

L579 was tested according to OECD/EC test guidelines in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of two different concentrations of S9-mix (rat liver S9-mix induced by Aroclor). L579 did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) or in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9 -metabolic activation. No cytotoxicity was observed and slight precipitation was seen at test concentrations of 1000 μg/plate and upwards (tested up to limit concentrations).

Based on the results of this study it is concluded that L579 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.

Chromosome aberration study

In a chromosome aberration study, cultured peripheral human lymphocytes were exposed to different concentrations of L579 (dissolved in DMSO), in the presence and absence of S9 -mix according to the most recent OECD and EC guidelines. In the first cytogenetic assay, L579 was tested up to 100 μg/ml for a 3 h exposure time with a 24 h fixation time (with L579 precipitating in the culture medium at this dose level). In the second cytogenetic assay, L579 was tested up to 333 μg/ml for a 24 h and 48 h continuous exposure time with a 24 h and 48 h fixation time in the absence of S9-mix (with L579 precipitating in the culture medium at 100 μg/l). In the presence of S9-mix L579 was tested up to 100 μg/ml for a 3 h exposure time with 48 h fixation time. L579 did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments. No effects of L579 on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that L579 does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations nor polyploidy.

Mouse lymphoma assay:

A mouse lymphoma assay was conducted according to OECD 476 guideline and GLP principles. The spontaneous mutation frequencies in the solvent-treated control cultures were between the minimum and maximum value of the historical control data range. Positive control chemicals, methyl methane sulfonate and cyclophosphamide induced appropriate responses. In the absence of S9-mix, L579 did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the duration of treatment time. In the presence of S9-mix, L579 did not induce a significant increase in the mutation frequency in the first experiment. This result was confirmed in an independent repeat experiment with modifications in the concentration of the S9 for metabolic activation. L579 was tested up to precipitating concentrations. Based on these data, it is concluded that halophosphate is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described in this report.


Short description of key information:
A chromosome aberration study, an AMES test (Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay) and a mouse lymphoma assay were conducted with and without metabolic activation according to current OECD/EC guidelines under GLP circumstances.
Based on the results of three different in vitro assays, it is concluded that halophosphate is not mutagenic with or without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, L579 does not have to be classified for mutagenicity according to CLP Regulation (EC) No 1272/2008.