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EC number: 828-365-9
CAS number: 113573-69-6
This study was designed to assess the potential of Xanthan lyase, batch PPE55581 to cause an increase in the induction of micronuclei in cultured human peripheral blood lymphocytes in vitro.
The study consisted of a preliminary toxicity test and a main micronucleus test. Human lymphocytes in whole blood culture, were exposed to Xanthan lyase, batch PPE55581 for 3 hours in both the absence and presence of exogenous metabolic activation (S9 mix) and for 20 hours in the absence of S9 mix. The maximum final concentration to which the cells were exposed was 7881 µg enzyme concentrate dry matter/mL (equivalent to 5000 µg Total Organic Solids (TOS)/mL, dosed at 10% v/v, which is the required dose according to OECD Guideline 487 (2016)).
Vehicle (water; purified by reverse osmosis) and positive control cultures were included in all appropriate test conditions.
In both the absence and presence of S9 mix, following 3-hour treatment, and in the absence of S9 mix, following 20-hour treatment, Xanthan lyase, batch PPE55581 did not cause any statistically significant increases in the number of binucleate cells containing micronuclei when compared with the vehicle controls and there was no evidence of a linear dose-concentration relationship. The mean micronucleus frequencies for the vehicle and test item treated cultures were within the laboratory historical control data 95% confidence limits. These results all fulfilled the criteria for clearly negative results.
The positive control compounds (mitomycin C, colchicine and cyclophosphamide) caused statistically significant increases in the number of binucleate cells containing micronuclei under appropriate conditions, demonstrating the efficacy of the S9 mix and the sensitivity of the test system.
It was concluded that Xanthan lyase, batch PPE55581 did not show evidence of causing an increase in the induction of micronuclei in cultured human lymphocytes, in this in vitro test system under the experimental conditions described.
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