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EC number: 947-751-9
CAS number: -
Piloerection in all test animals.
There was no effect on this ratio.
There was no increase in the incidence of
micronucleated cells in the test group. The incidence of micronuclei in
the contorl group was within historical control ranges. The positive
control group produced an appropriate increase in numbers of
An in vivo study was conducted to determine
the genotoxic potential of the test substance, 1-dodecanol (purity not
specified) in mice, according to OECD Guideline 474 (Micronucleus test),
in compliance with GLP. In this study, 12 mice (6 per sex) per dose,
were administered single dose of each, test substance (5000 mg/kg bw
dodecanol in arachis oil), positive control (Cyclophosphamide 20 mg/kg
bw) and solvent control (Arachis oil) substances at 10 mL/kg bw dose, by
oral gavage. The maximum tolerated dose (MTD) of 5000 mg/kg bw was
determined in a screening test. Samples of blood were collected and
analysed 24, 48 and 72 h after treatment period. Two slides were
prepared for each animal and 1000 polychromatic erythrocytes (PCE)
scored. A statistically significant (p<0.05) increase in PCE compared to
normochromatic erythrocytes (NCE) was examined by Kastenbaum & Bowman
method. Clinical examination was performed daily. No mortality was
observed during the study. Only reported clinical sign was piloerection
in all animals. There was no increase in the incidence of micronucleated
cells in the test group. The incidence of micronuclei in the control
group was within historical control ranges. The positive control group
produced an appropriate increase in numbers of micronucleated cells. No
statistically significant increase in micronucleated polychromatic
erythrocytes in mice was observed at any time interval after treatment
(24, 48 or 72 h) at dose levels up to 5000 mg/kg bw when compared to
vehicle controls (PCE/NCE ratio), whereas the positive control group did
produce a statistically significant increase. The study had met all the
validity criteria required for the test. Under the study conditions, the
test substance was concluded to be non-clastogenic in the micronuleus
assay in mice (OECD SIDS, 2006).
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