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EC number: 268-074-9
CAS number: 68002-61-9
This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl trimethyl ammonium chloride and SDA Reporting Number: 11-045-00.
A study was conducted to determine the oral repeated dose toxicity of the source substance, TMAC C16 (24 -26% active in water), according to a method similar to OECD Guideline 407, in compliance with GLP. Groups of 10 male and female rats were administered 0, 30, 100 and 300 mg/kg bw/day of source substance by oral gavage for 28 days. The source substance used was a 24-26% aqueous solution but it is not clear if the doses mentioned were corrected. There were no treatment-related changes at the 30 and 100 mg/kg bw/day. In the high-dose group there was an increase in water consumption, changes in the absolute and relative weights of the adrenals and spleens (in males) without corresponding effects on haematology, clinical chemistry and histology. The forestomach of the high-dose group showed few microscopic changes, however animals in the high-dose recovery group showed a complete and regular regeneration of the forestomach mucosa. Hence, the forestomach effects were considered to be due to the irritating properties of the source substance rather than symptoms of systemic toxicity. Under the study conditions, the rat 28 d NOEL for systemic effects was considered to be at 100 mg/kg bw/day, which is corrected to 25 mg a.i./kg bw/day (assuming its not been done in the study report) (Potokar, 1991). Based on the results of the source study, similar effects and NOAEL can be expected for the target substance.
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