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EC number: 200-609-3 | CAS number: 65-45-2
Metabolism of salicylamide in mice was assessed after intraperitoneal administration of 274.3 and 548.5 mg/kg bw. The concentrations of salicylamide and its metabolites in blood and urine were determined at various time points using HPLC-UV. Glucuronides and sulfates were detected using glucuronidase/sulfatase treatment of samples before injection.
2.3-Dihydroxybenzamide (2,3-DBA), 2.5-dihydroxybenzamide (gentisamide), and their sulfates and glucuronides were identified besides the sulfates and glucuronides of salicylamide as major metabolites of salicylamide in blood and urine.
Short description of key information on bioaccumulation potential result: metabolites identified, mice, i.p., Howell 1988metabolites/kinetics identified, humans, oral/rectal, de Boer 1983
A very large body of work exists in the literature (see literature search) addressing the pharmacokinetics and pharmacodynamics of salicylamide, both in vitro and in vivo (several species). Various aspects of ADME were addressed, but none according to guideline methods, and usually with non-standard methodology. For oral administration, almost complete metabolism was observed after absorption and first-pass through the liver. Two studies were selected which identified the main metabolites, as well as the absorption and elimination kinetics.
Howell (1988) investigated the metabolism of salicylamide in mice after intraperitoneal administration of 274.3 and 548.5 mg/kg bw. The concentrations of salicylamide and its metabolites in blood and urine were determined at various time points using HPLC-UV. Glucuronides and sulfates were detected using glucuronidase/sulfatase treatment of samples before injection. 2,3-Dihydroxybenzamide (2,3-DBA), 2,5-dihydroxybenzamide (gentisamide), and their sulfates and glucuronides were identified besides the sulfates and glucuronides of salicylamide as major metabolites of salicylamide in blood and urine.
Direct observations: clinical cases - toxicokinetics
De Boer et al. (1983) gave salicylamide to 6 human volunteers by oral or rectal administration at 500 or 1500 mg/person. Blood samples were obtained in regular intervals to quantify free salicylamide in plasma. Urinary samples were also collected and checked for salicylamide and its conjugates (sulfate and glucuronide). After oral administration, salicylamide was absorbed very quickly into the plasma with a mean peak time of 12±2.7 min. The peak concentration was then 30.9±9.2 g/mL (dose administered: 1500 mg). Elimination from plasma was also quite fast with half-lives of 12 and 31 min after administration of 500 and 1500 mg salicylamide, respectively. Excretion was performed mainly via urine after conjugation with sulfate or glucuronic acid. Urinary excretion half life was 63 min (dose: 1500 mg). After rectal administration plasma concentration of free salicylamide and urinary concentration of conjugates were significantly lower compared to oral administration.
The rapid metabolism and excretion indicate no potential for bioaccumulation.
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