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EC number: 700-891-2
CAS number: -
In the assays without metabolic activation (4, 20 or 44-hour treatment),
strong to moderate cytotoxicity was noted at the highest concentration
tested of 162.5 μg/mL, with 39.3 to 65.4% of mitotic index compared to
the control. In the assays with metabolic activation with either 5 or
10% of S9-mix, moderate and no cytotoxicity was noted at the highest
concentration tested of 162.5 μg/mL, with 106.7 and 65.6% of mitotic
index compared to the control, respectively. Under these conditions, the
concentration of 162.5 μg/mL was retained as the maximum concentration
to be tested in each assay either with or without metabolic activation.
GENOTOXICITY ASSAY Carried out both without and with metabolic
activation using Aroclor1254-induced S9 from rat livers (S9-mix) -
Number of assays : 2 - Number of replicate cultures : 2 per
concentration - Factor limiting the maximum concentration tested :
• Without S9-mix : 4 h + 20 h recovery period (short treatment) 20 and
44 h without recovery period (continuous treatment)
• With S9-mix : 4 h + 20 h recovery period, with 5% or 10 % S9-mix -
Concentrations tested expressed as μg/mL LCE10031:
• Without S9 mix : 162.5 – 108.33 – 72.22 – 48.15 (assay 1: 4-hour
treatment) 162.5 – 108.33 – 72.22 – 48.15 (assay 2: 20-hour treatment)
162.5 – 108.33 – 72.22 – 48.15 (assay 2: 44-hour treatment)
• With S9 mix : 162.5 – 108.33 – 72.22 – 48.15 (assay 1: with 5% S9-mix)
162.5 – 108.33 – 72.22 – 48.15 (assay 2: with 10% S9-mix)
The test item induced no statistically significant increase in the
number of breaks per cell and in the frequency of aberrant cells
excluding or including gaps in the treatments with or without metabolic
activation. It is to be noted that during the 1st reading, an exchange
was noted during the 2nd assay following a 44-hour treatment without
S9-mix. As this event could constitute an alert for clastogenesis, a
complementary reading was performed. In this new reading, no other
specific event of clastogenesis was noted. Therefore, this effect was
not considered as biologically significant. Furthermore, no
statistically significant increase in the number of cells with numerical
aberrations was noted in any treatment.
The acceptance criteria for the results were fulfilled. The current
study was considered as valid. Under these experimental conditions, the
test item induced no clastogenic activity in human lymphocytes both in
presence and in absence of metabolic activation, in the in vitro human
lymphocyte metaphase analysis test.
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