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A toxicological evaluation of a novel cooling agent, 2-(4-methylphenoxy)- N -(1 H -pyrazol-3-yl)- N -(2-thienylmethyl) acetamide (S2227; CAS 1374760-95-8), was completed for the purpose of assessing its safety for use in food and beverage applications. S2227 undergoes rapid oxidative metabolism in vitro , and in rat and dog pharmacokinetic studies is rapidly converted to its component carboxylic acid and secondary amine. S2227 was not found to be mutagenic or clastogenic in vitro , and did not induce micronuclei in polychromatic erythrocytes in vivo . The secondary amine hydrolysis product, N -(2-thienylmethyl)-1 H -pyrazol-3-amine (M179), was also evaluated for genotoxicity. In subchronic oral toxicity studies in rats, the no-observed-adverse-effect-level (NOAEL) for S2227 was 100 mg/kg/day (highest dose tested) when administered by oral gavage for 90 consecutive days. Furthermore, S2227 demonstrated a lack of maternal toxicity, as well as adverse effects on fetal morphology at the highest dose tested, providing a NOAEL of 1000 mg/kg/day for both maternal toxicity and embryo/fetal development when administered orally during gestation to pregnant rats.

Toxicological evaluation of a novel cooling compound: 2-(4-methylphenoxy)- N -(1 H -pyrazol-3-yl)- N -(2-thienylmethyl)acetamide