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EC number: 640-107-5 | CAS number: 151789-06-9
The analogue approach using coco alkylamines as source chemical is justified:
a. Both target and source chemicals are fatty nitrogen derived amines with structural similarities.Therefore, it can be assumed that target and source chemicals share the same toxic mode action.
b. The target and source chemicals have similarities in their toxicity potentials.The findings from in-silico tool DEREK are comparable for target and source chemicals. No toxicological concerns are identified based on their structures.
c. The result of the analogue approach on the endpoint of acute oral toxicity is supported by the hazard characterization of the fatty nitrogen derived ether amines category 1 evaluated by US EPA through the High Production Volume (HPV) Program.
The acute oral toxicity of the target substance was assessed based on the read-across appoach using coco alkylamines as read-across supporting substance.
In an OECD TG 401 study, the test material Armeen C, a clear light-yellow, oily liquid, was orally applied to Wistar rats at doses of 500, 1000, 1500 and 2000 mg/kg bw. The substance was applied as a 20% solution in peanut oil (pH 8.1). At 500 mg/kg bw, two males died 5 and 7 days after treatment, respectively. At 1000 mg/kg bw, two males and two females died between days 5-14 (40%). At 1500 mg/kg bw, four males and four females and at 2000 mg/kg bw (80%), ten males and nine females died between days 5-14 (95%). An LD50 of 1300 mg/kg bw (1240 mg for male and 1390 mg for female rats) was calculated (probit analysis after Finney). Clinical signs, observed in all treatment groups, included apathia, slight to pronounced irregular postures, uncoordinated movements, reduced reflexes, cyanosis, salivation, piloerection, slightly reduced breathing rate and some cases of slight hypothermia. Symptoms started from 20 minutes after dosing on and were present until death or up to 7 days in survivors. After dissection of dead animals, slight reddening and liquid congregations were detected in the gastrointestinal tract. There were no pathological findings in the surviving animals.
Based on the analogue approach using coco alkylamine as read-across supporting substance, the median lethal dose (LD 50) of the target substance is considered to be 1300 mg/kg/bw.
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