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EC number: 239-701-3 | CAS number: 15625-89-5
Validity criteria followed:
This study was considered valid since the following criteria were met:
• the frequency of cells with structural chromosome aberrations in the vehicle controls was consistent with CIT historical data,
• The frequency of cells with structural chromosome aberrations in the positive control tests was significantly higher than that of the vehicle controls and consistent with CIT historical data.
An in vitro mammalian cell chromosomal aberration study was carried out with trimethylolpropane triacrylate in accordance with OECD TG 473, EU Method B.10, Japanese guidelines and EPA OPPTS method 870.5375.
A preliminary experiment was carried out with trimethylolpropane triacrylate 23.1, 45.7, 92.6, 185, 370, 740, 1480 and 2960 μg/mL both with and without S9 mix. In the main experiment, primary cell cultured human peripheral blood from two donors were incubated with Trimethylolpropane Triacrylate at the following concentrations:
1) 0.78, 1.56, 3.13, 6.25, 12.5, 18.75, 25 and 37.5 μg/mL without S9 mix (first experiment);
2) 1.56, 3.13, 6.25, 12.5, 18.75, 25, 37.5 and 50 μg/mL with S9 mix (first experiment);
3) 3.13, 6.25, 9.38, 12.5, 18.75 and 28.13 μg/mL without S9 mix (second experiment);
4) 9.38, 18.75, 28.13, 37.5, 50 and 75 μg/mL with S9 mix (second experiment).
Cytotoxicity was observed at all concentrations of the preliminary experiment. Hence this study was rejected. Cytotoxicity ranged from 45 to 100% in the first experiment and 26 to 83% in the second experiment at concentrations ≥ 12.5 μg/mL.
Statistically significant and concentration-related increases in the frequency of cells with structural chromosomal aberrations were noted at concentrations ≥ 9.38 μg/mL with metabolic activation. Statistically significant increases in the frequency of cells with structural chromosomal aberrations were noted at concentrations at and above 28.13 μg/mL.
In conclusion trimethylolpropane triacrylate induced chromosome aberrations in cultured human lymphocytes both with and without metabolic activation.
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