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Administrative data

Link to relevant study record(s)

Description of key information

Four experiments were conducted as part of the study which involved the determination of the absorption, distribution, metabolism and excretion (ADME) patterns of 14C-5,5-dimethylhydantoin. The dosing regimens were as follows: A single oral low-dose(100mg/kg); a single oral high- dose(1000mg.kg);  repeated oral low- dose (100mg/kg/day of non-radiolabelled DMH for days 1-7 and80mg/kg/day for days 8-14 followed by a single dose of 14C-DMH); A single I.V low-dose (100mg/kg)

Key value for chemical safety assessment

Additional information

DMDMH readily undergoes hydrolysis to form DMH. The available data demonstrates that DMH is well absorbed and rapidly and quantitatively excreted, unchanged, in the urine following oral or intravenous administration. There was no evidence for significant tissue accumulation.