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EC number: 245-844-2
CAS number: 23726-93-4
In an acute dermal toxicity study, groups of
CD® Sprague-Dawley outbred albino rats (5/sex/dose) were given single
dermal application of test material diluted in alcohol at 1670, 2150,
2780, 3600 and 4640 mg/kg bw at a constant volume of 6 mL/mg bw. Test
material was applied topically to the previously shaven dorsal area of
the animal and remained in contact for 24 h. A vehicle control group was
treated with undiluted alcohol in the same manner. Animals were then
observed for mortality, clinical signs and bodyweights for 14 days and
at the end of the study the surviving animals were sacrificed for
Range finding study was conducted at the
dose levels of 50, 160, 500, 1600 and 5000 mg/kg bw (2/sex/dose) to
determine the dose levels for main study. In the range-finding study, no
mortality or signs of compound induced toxicity were observed at 0, 50,
160 or 500 mg/kg bw. Mortality was observed in one male and two females
at 5000 mg/kg bw.
In the main study, no mortality was observed at
1670 or 2150 mg/kg bw. 3/10 (0 male + 3 females), 5/10 (0 male + 5
females) and 10/10 (5 males + 5 females) animals died at 2780, 3600 and
4640 mg/kg bw, respectively. Soft feces, mucous discharge or morbidity
were observed ante mortem in animals receiving 2780, 3600 or 4640 mg/kg
No mortality and no dermal irritation was
observed in the vehicle control animals.
Desquamation was observed between Days 7 and
14 in animals exposed to 1670, 2150, 2780 and 3600 mg/kg bw. The mean
body weight gain was slightly lower in males at 1670, 2150, 2780 and
3600 mg/kg bw and moderately lower in females at 2150 mg/kg bw when
compared to vehicle control. Mean body weight gains for the females
receiving 1670 and 2780 mg/kg bw were comparable to the controls. No
gross tissue alterations attributable to treatment were observed in any
of the animals.
Dermal LD50 Combined = 2900 mg/kg bw (95
% confidence limits of 2164-3886 mg/kg bw).
Under the test conditions, the test material
is not classified according to the annex VI of the Regulation EC No.
This study is acceptable and satisfies the
requirement for acute dermal toxicity endpoint.
The supporting substance is considered
adequate for read-across purpose (see Iuclid section 13 for
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