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EC number: 203-570-0 | CAS number: 108-30-5
For Tables See Attachment.
The cell cultures were evaluated at the following concentrations:
without S9 mix: 37.5; 75.0; 150; 300; 600; and 1200 µg/mL
with S9 mix: 37.5; 75.0; 150; 300; 600; and 1200 µg/mL
without S9 mix: 75.0; 150; 300; 600; 900; and 1200 µg/mL
with S9 mix: 75.0; 150; 300; 600; 900; and 1200 µg/mL
The maximum concentration of the test item in the main experiments is equal to molar concentration of approximately 10 mM.
No precipitation of the test item was observed up to the maximal concentration in all ex-periments.
Cytotoxic effects as indicated by a relative cloning efficiency of less than 50 % in both parallel cultures solely occurred at 900 µg/mL and above in experiment II without metabolic activation following 24 hours of exposure.
No relevant and reproducible increase in mutant colony numbers/10E6 cells was observed in the main experiments up to the maximum concentration. The induction factor exceeded the threshold of three times the corresponding solvent control in the first culture of the second experiment without metabolic activation at 900 and 1200 µg/mL. This effect, however, was not reproduced in the parallel culture performed under identical conditions. Furthermore, the increase was not dose dependent as indicated by the lacking statistical significance.
A linear regression analysis (least squares) was performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT®11 statistics software. A significant trend of the mutation frequency was solely determined in the first culture of the first experiment without metabolic activation. This trend was judged as irrelevant fluctuation however, since it actually was reciprocal, going down versus increasing concentrations.
In both experiments of this study (with and without S9 mix) the range of the solvent controls was from 10.7 up to 28.5 mutants per 10E6 cells; the range of the groups treated with the test item was from 9.2 up to 59.1 mutants per 10E6 cells.
EMS (225 µg/mL) and DMBA (1.1 µg/mL) were used as positive controls and showed a distinct increase in induced mutant colonies.
The study was performed to investigate the potential of Maleic acid to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. The highest applied concentration (1200 µg/mL) was equal to a molar concentration of approximately 10 mM - the limit for this assay.
No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments. Appropriate reference mutagens, used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test item and the activity of the metabolic activation system.
In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Maleic acid is considered to be non-mutagenic in this HPRT assay.
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