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EC number: 201-051-3
CAS number: 77-71-4
Short description of key information on bioaccumulation potential result: An ADME study was performed in the rat in accordance to GLP and EPA OPP Guideline 85-1. No bioaccumulation potential based on study results. 14C-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. HPLC profiles for composited male and female urines collected for the qualitative analysis allowed to conclude that unmetabolised DMH was the only14C-residue found in the urine.
Regardless of dosing regimes, more than 90% of the dosed radioactivity
in both male and female rats was excreted, unchanged, in the urine
(90.50-96.25%) while less than 1.37% was excreted in the faeces. Most of
the radioactivity recovered in the urine was excreted within the first
12 hours. Urinary half lives were superimposable, with values of
3.0-3.25h (males) and 2.4-2.8 h (females). Test substance DMH was
adsorbed completely and readily.
Distribution in tissues
Tissue residues expressed as ppm 14C-DMH equivalents and percent of
administered dose were very low and with the exception of the single
oral high-dose group, were similar for all dosage regimens. The slightly
higher tissue residue levels in a few tissues in the single oral
high-dose group were considered to be a reflection of the higher dose
administered to the animals in this group. Only in hair and possibly
fat, were residue levels above those found in plasma found with any
regularity. The slightly higher residue levels in fat were not of the
magnitude to suggest significant bioaccumulation. The residue levels in
hair may indicate some preference for 14C-DMH to accumulate in this
matrix or may be an artefact of trying to determine 14C residue levels
in extremely small samples.
Only one substance was excreted in urine (90-96% of initial measured
dose); it was identified as unchanged 14C-DMH by HPLC. No
metabolites was identified.
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