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EC number: 411-370-1
CAS number: 82857-68-9
GM 102 E
The acute dermal toxicity
of the test item GM102E was investigated in a limit test performed on
Sprague Dawley rats.
The study was performed
according to EU method B.3 and in compliance with GLP.
The test item was
administered once on 5 males and 5 females using patch applied on the
dorsal surface. The test item was tested at the concentration of 2000
mg/kg. No washing was performed and residual substance was wiped off
after 24-hour exposure period.
The animals were then
observed during 14 days. Clinical signs were observed at 30 min, 2, 4, 6
hours post dosing, then twice daily while weight was measured twice
before dosing (at randomisation and on day 1 before treatment), then on
day 8 and 15.
One female rat died during
the study (day 2). Piloerection and hunched posture were observed before
death and congestion and increased size of the spleen were the only
findings at autopsy. No general clinical signs were seen in the
surviving animals, but they showed erythema, edema, and crusts at the
application site starting from days 2-3 and lasting up to days 3-11 of
the study. The body weight gain appeared normal. No changes were found
at the gross pathology examination performed at the end of the
observation period in any rat.
Mortality was confined to
only one animal and only local irritation was observed at the
application site on the other rats. Thus the LD50 was considered to be >
2000 mg/kg b.w.
Based on these results and
according to the Regulation (EC) No 1272/2008 on classification,
labelling and packaging of substances and mixtures (CLP), GM102E should
not be classified for dermal toxicity.
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