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EC number: 266-380-7
CAS number: 66492-51-1
Rat, oral, combined rep. dose/developmental screening study (BASF, 2013, OECD 422, GLP): NOAEL systemic > 250mg/kg, local irritation occured in 7/10 males at 250mg/kg
(5-ethyl-1,3-dioxan-5-yl)methyl acrylate was administered orally by
gavage to groups of 10 male and 10 female Wistar rats at dose levels of
0 mg/kg body weight/day, 40mg/kg bw/d, 100mg/kg bw/d, and 250mg/kg bw/d
in corn oil, adjusted to the purity of the substance (78.1g/100g). The
doses were selected based on a 14day test study in female rats. During
this study, one female receiving 1000mg/kg b.w. died on day 13 due to
severe irritation in the digestive system. Ulcerations / erosions and
dicolored jejunal content were also seen in the surviving 3 females.
Ulceration in one female of the mid dose receiving 500mg/kg b.w. was
also judged as severe enough, that it would lead to the death of this
animal throughout a longer treatment period. Thus the low dose of
250mg/kg, where slight ulcerations were also observed in one animal, was
set as the high dose for the main study.
The duration of treatment in the main study covered 31days for males and
52 days for females. A detailed clinical observation was performed in
all animals before initial test substance administration and at weekly
intervals thereafter. Food consumption and body weight of the animals
were determined in app. weekly intervals. Towards the end of the
administration period a functional observational battery was performed
and motor activity was measured in 5 animals per sex and test group.
Clinicochemical and hematological examinations as well as urinalyses
were also performed towards the end of the administration period in 5
animals per sex and test group. All animals were sacrificed by
decapitation, under isoflurane anesthesia, and were assessed by gross
pathology. Weights of selected organs were recorded and a
histopathological examination was performed. Aside from hyperkeratosis
in 7 out of 10 males in the high dose group, which is seen as a sign of
local irritation and not systemic toxicity, no test substance related
effects were observed. Thus, the NOAELs for systemic toxicity was set to
250mg/kg b.w., the highest dose tested.
No systemic toxicity has been observed, thus
(5-ethyl-1,3-dioxan-5-yl)methyl acrylate does not have to be classified
according to 67/548/EEC or CLP/EU-GHS.
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