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EC number: 442-390-9
CAS number: 40573-09-9
The mutagenic potential of the test article was evaluated in the
Bacterial Reverse Mutation Assay with S. typhimurium strains TA98,
TA100, TA102, TA1535, and TA1537 in the presence and absence of a
metabolic activation system (Aroclor induced-S9 mix). The study was
performed in compliance with OECD GLP (1999). The test
method was based on OECD No. 471 (1997), U.S. EPA: OPPTS 870.5100
(1998), and EC Directive 2000/32/EC B.13/B.14. All
strains were exposed to dose levels of 50, 160, 500, 1600, or 5000 ug
per plate by incorporation of the test article into the agar. Strain
specific experiments were performed in the presence and absence of
metabolic activation. Plates were incubated for 48
hours at 37 C in the dark. After incubation, revertant
colonies were counted. No mutagenic responses were
observed in any strain in the presence or absence of metabolic
activation. Based on the results of the test, the test
article is not mutagenic with or without metabolic activation in
the Ames assay.
The potential clastogenicity of the test article was evaluated in the
micronucleus test. The study was conducted according
to OECD GLP (1997), US FDA GLP, and US EPA GLP regulations. The
test method was based on EEC Directive 2000/32/EC, Part B.12 (June 8,
2000) and OECD Guideline 474 (July 21, 1997). The test material was
administered as received. Five male rats per group were administered
Milli-Q water (negative control), 50 mg/kg cyclophosphamide (CP,
positive control) or the test article at 2000 (two group) mg/kg via oral
intubation. Bone marrow was harvested at 24 hours (one test article
group and negative control) and 48 hours (one test article group and
positive control) after dosing. All animals were
normal immediately after dose administration. The incidence of
micronucleated polychromatic erythrocytes in the bone marrow of negative
control animals was within the historical range and CP (positive
control) induced a significant increase in the number of micronucleated
polychromatic erythrocytes indicating that the assay was valid. No
increase in the mean frequency of micronucleated polychromatic
erythrocytes was observed in the bone marrow of animals treated with the
test article. Animals treated with the test article showed no decrease
in the ratio of polychromatic to normochromatic erythrocytes compared
with the negative controls which indicated there was no toxic effect on
the erythropoiesis. Based on the results of this test, the test article
is not clastogenic.
Criteria for classifying the test article as mutagenic are not met.
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