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EC number: 695-748-3
CAS number: 65286-55-7
The test substance was tested to evaluate the potential to induce structural chromosomal aberrations using Chinese hamster ovary (CHO) cells in both the absence and presence of an exogenous metabolic activation system. CHO cells were treated for 4 hours in the absence and presence of S9, and for 20 hours in the absence of S9. Water was used as the vehicle.
In the preliminary toxicity assay, the doses tested ranged from 0.2 to 2000 µg/mL, which was the limit dose for this assay. Cytotoxicity ( ≥ 50% reduction in cell growth index relative to the vehicle control) was not observed at any dose in any of the three exposure groups. Based upon these results, the doses chosen for the chromosome aberration assay ranged from 100 to 2000 µg/mL for all three exposure groups.
In the chromosome aberration assay, cytotoxicity ( ≥ 50% reduction in cell growth index relative to the vehicle control) was not observed at any dose in any of the three exposure groups. The doses selected for evaluation of chromosome aberrations were 500, 1000, and 2000 µg/mL for all three exposure groups.
In the non-activated 4 and 20-hour exposure groups, no significant or dose‑dependent increases in structural aberrations were observed at any dose (p > 0.05; Fisher’s Exact and Cochran-Armitage tests).
In the S9-activated 4-hour exposure group, statistically significant increases in structural aberrations (3.3%) were observed at doses 1000, and 2000 µg/mL (p ≤ 0.05; Fisher’s Exact). However, the Cochran-Armitage test was negative for a dose response (p > 0.05). In addition, the increase was within the historical 95% control limit of 0.00% to 3.88%. Since the significant increases in structural aberrations did not meet any criteria for a positive response, the statistical significance can be attributed to the 0.0% induction of structural aberrations in the vehicle control. Therefore, the statistically significant increase in structural chromosomal aberrations was considered biologically irrelevant.
No significant or dose‑dependent increases in numerical (polyploid or endoreduplicated cells) aberrations were observed at any dose in any of the treatment groups (p > 0.05; Fisher’s Exact and Cochran-Armitage tests).
These results indicate that the test substance was negative for the induction of structural and numerical chromosome aberrations in the presence and absence of the exogenous metabolic activation system.
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