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EC number: 246-186-9
CAS number: 24347-58-8
The test substance (2R,3R)-butane-2,3 -diol was evaluated for its
potential to induce chromosome aberration by performing the in vitro
mammalian chromosomal aberration test with cultured Chinese hamster lung
cell line (CHL) in the absence (S9 -) and presence (S9 +) of metabolic
activation system. The study was performed according to OECD 473
(adopted 2016) and in compliance with GLP. Concentration range-finding
test was performed on cell cultures using a short-term treatment assay
in the absence of S9 mix (referred to as –S9 mix) and in the presence of
S9 mix (referred to as +S9 mix) and continuous treatment test (referred
to as 24 hour exposure, S9 -). The concentration range used was 62.5,
125, 250, 500, 1000 and 2000 μg/mL. After 24 hours exposure, relative
increase in cell counts (RICC) was observed by more than 60% at –S9 mix
and +S9 mix. The RICC (55 ± 5) % was 443.72 μg/mL (24 hours exposure).
Based on the result of concentration range-finding test, concentrations
of 125, 250, 500, 1000 and 2000 μg/mL were chosen for the main test.
First, the chromosomal aberration test (short-term treatment method) was
conducted with and without S9-mix. Results showed that the frequencies
of aberration cells with structural aberration and numerical aberrations
of chromosome were less than 5% for both S9- and S9+. Since all results
were negative under both conditions of short-term treatments,
chromosomal aberration test continuous treatment for 24 hour exposure
without S9-mix and a second short-term treatment (S9+) followed.
Continuous treatment (24 hour exposure) was conducted at 31.3, 62.5,
125, 250 and 500 μg/mL, and the second short-term treatment (+S9 mix)
was conducted at 500, 1000 and 2000 μg/mL. Observation of specimens were
conducted at all treatment groups in the 24 hour exposure and the second
short-term test. Results showed that frequencies of aberration cells
with structural aberration and numerical aberrations of chromosome were
less than 5% in the long-term (S9-) and short-term (S9+) test.
Therefore, the test substance was considered to be non-clastogenic
(Negative) to CHL/IU cells under the present experimental condition.
The study was considered reliable and adequate for risk assessment.
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