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EC number: 243-500-6
CAS number: 20073-51-2
In a mammalian chromosomal aberration test, human peripheral blood
lymphocytes, cultured in vitro, were exposed to POLIOL MB 600 at different concentrations, in the
absence and presence of the metabolic activation (2% v/v S9 mix).
Based on results of preliminary solubility and cytotoxicity tests, 80 µg/mL, in the absence of the
metabolic activation in Phase I and II and 125 µg/mL in the presence of the metabolic activation (2% v/v
S9 mix) were selected as the highest test concentration for the main study. POLIOL MB 600 was tested in
two phases, with (2% v/v S9 mix) and without metabolic activation (4h exposure) and second phase (24h
exposure) without metabolic activation. Hence, human peripheral blood lymphocyte cultures were
exposed to POLIOL MB 600 at six concentrations (two cultures/concentration in each experiment) from 5
to 80 µg/mL, in the absence in Phase I and II and 3.91 to 125 µg/mL in the presence of the metabolic
POLIOL MB 600 did not induce any statistically significant or biologically relevant increase in the
number of percent aberrant cells, in the absence and presence of S9-mix for the short term (phase-I, 4
hours) and in the absence of S9, long term (phase-II, 24 hours) exposure period. No effect of POLIOL
MB 600 on the number of polypoid cells was observed, in the absence (phase I and phase II) and presence
of S9-mix (phase I) in both phases. All negative controls were comparable to historical control limits and
positive controls showed an increase in the incidence of cells with chromosomal aberrations.
All criteria for a valid study were met, as described in the study plan. From results of this study, it is
concluded that POLIOL MB 600 did not show any potential to induce chromosomal aberrations either in
the absence or presence of the metabolic activation system, under the described experimental conditions
and is considered to be negative for clastogenicity.
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