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EC number: 308-208-6 | CAS number: 97925-95-6
Atmer 163 is harmful if applied by the oral route. Inhalative and dermal route haven't been evaluated due to Atmer 163's corrosive character.
Clinical signs observed in this study are reported to be indicative of excessive para-sympathetic nervous activity. Atmer 163 with a LD50 of 1500 mg/kg bw in male and 1300 mg/kg bw in female rats by oral route has to be classified:
CLP: Category 4, H302 (harmful if swallowed)
DSD: Xn, R22 (harmful)
Skin corrosion/irritation studies on rabbit skin revealed that Atmer 163 is classified as corrosive to the skin. Although a study for oral toxicity of Atmer 163 was performed, acute toxicity studies do not generally need to be conducted according to Annex VIII 8.5 column 2 if the substance is classified as corrosive to the skin.
An acute oral toxicity study has been performed with Alderley Park, SPF-derived, albino strain rats according to Standard Operating Procedure No CT20-090/01 and similar to OECD guideline 401 (CTL/T/1357). The animals were treated with a 20% (w/v) emulsion in corn oil for a dose of 2000 mg/kg bw and as a 15%, 13.5%, 12.5% 10% and 5% (w/v) emulsion in corn oil for doses of 1500, 1350, 1250, 1000 and 500 mg/kg bw respectively. Animals were observed up to 8 days and clinical signs reported. At 2000 mg/kg bw 4 male and 5 female were dead by day 6 and animals showed subdued appearance, piloerection, chromodacryorrhoea, scouring, curvature of spine, laboured respiration and a red stain around the snout. At 1500 mg/kg bw 2 male and 4 female were dead by day 8 and slight piloerection, incontinence, salivation and an ungroomed appearance were observed. At 1350 (only females treated, all dead by day 4), 1250 (only females treated, no deaths), 1000 (1 male dead by day 4) and 500 mg/kg bw (no deaths) incontinence, salivation, lacrymation and laboured respiration occurred. Clinical signs observed in this study are reported to be indicative of excessive para-sympathetic nervous activity. Atmer 163 with a LD50 of 1500 mg/kg bw in male and 1300 mg/kg bw in female rats by oral route has to be classified.
Justification for selection of acute toxicity – oral endpoint The reliable key study was choosen. Justification for selection of acute toxicity – inhalation endpoint No study required due to Atmer 163's corrosive character. Justification for selection of acute toxicity – dermal endpoint No study required due to Atmer 163's corrosive character.
An acute oral toxicity study in rats yielded in a LD50 of 1300 mg/kg bw for female and 1500 mg/kg bw for male rats. According to CLP Atmer 163 has to be classified:
CLP: Category 4, H302
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