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EC number: 266-380-7
CAS number: 66492-51-1
Gene mutation in bacteria
Gene mutation in mammalian cells
5 -ethyl-1,3 -dioxan-5 -yl-methyl acrylate was also not mutagenic
in a HPRT assay using CHO cells. After an attachment period of 20 - 24
hours and a treatment period of 4 hours both with and without metabolic
activation and 24 hours without metabolic activation, an expression
phase of about 6 - 8 days and a selection period of about 1 week
followed. The colonies of each test group were fixed with methanol,
stained with Giemsa and counted. S9 fraction was prepared
from the liver of male Sprague-Dawley rats, treated with a single dose
of phenobarbital and β-naphthoflavone. The doses used were selected
according to the cytotoxic properties of the test substance as
determined in a range-finding study:
Cytotoxicity was observed at the next higher dose used.
Genetic toxicity in vivo
A micronucleus test was conducted using the intraperitoneal route
in groups of seven mice (males) at the maximum tolerated dose (MTD) 300
mg/kg and at 150 and 75 mg/kg. Animals were killed 24 or 48 hours (only
high dose) later, the bone marrow was extracted, and smear preparations
made and stained. Polychromatic ( PCE) and normochromatic (NCE)
erythrocytes were scored for the presence of micronuclei. 7 mice were
dosed intraperitoneally with arachis oil as negative control, and 5
futher mice dosed orally with cyclophosphamide served as positive
Hunched posture, ptosis, tip-toe gait, and pilo-erection were
observed in animals of all groups. A modest statistically significant
decrease in the PCE/NCE ratio was observed in the 24-hour 300 mg/kg test
item group when compared to the vehicle control group. Although not
statistically significant, modest decreases in the PCE/NCE ratio were
also observed after 48 -hour in high dose mice and in animals of the 150
mg/kg group. These decreases, together with the observation of clinical
signs, were taken to indicate that systemic absorption had occurred and
exposure to the target tissue had been achieved.
There was no evidence of a significant increase in the incidence
of micronucleated polychromatic erythrocytes in animals dosed with the
test item when compared to the vehicle control group. Positive control
mice showed the expected increase in micronucleated
5 -ethyl-1,3 -dioxan-5 -yl-methyl acrylate did not induce gene mutations
in bacteria or mammalian cells. It was also non-genotoxic in an in vivo
micronucleus test, while inducing systemic toxicity. Thus, the
substance has not to be classified according to EU criteria (67/548/EEC)
or CLP/EU-GHS for genetic toxicity.
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