D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.

Endpoint summary

Description of key information

No data are available on the absorption, distribution, metabolism or elimination (ADME) of Glucamide 810.  However, based on the close structural similarity and generally comparable metabolic pathway, data can be read across from data generated on Glucamide 24. For this compound, oral absorption was greater 80% over a 72 hour period with more than 99% excreted urine. No bioaccumulation potential was detected. Dermal absorption was below 1% over a 72 hour test period and thus negligible.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Absorption rate - oral (%):

80

Absorption rate - dermal (%):

1

Additional information

No data are available on the absorption, distribution, metabolism or elimination (ADME) of Glucamide 810. However, based on the close structural similarity and common metabolic pathway, data can be read across from data generated on Glucamide 24.

After oral application, the absorption, distribution, metabolism and excretion (ADME) of radiolabeled n-lauryl-glucose amide ([¹⁴C]-C₁₂-G5 Base (Glucamide 24, radioactive purity 99.1%) was investigated in fasted male Sprague-Dawley rats (4 in total). Following oral administration of 150 mg/kg bw dose in ethanol:water (20:80), 79.7%, 16.03%, 0.31% and 0.18% of radioactivity was recovered in the urine (plus cage wash), feces (plus gastrointestinal tract wash), expired CO₂, and tissue plus carcass, respectively, at the end of 72 hours with the largest amount of radioactivity collected in the 8-24 hour test period. Individual tissue distribution at 72 hours indicated that the highest levels in the liver (16x plasma radioactive content) followed by kidneys, spleen, carcass, lungs and gastrointestinal tract. All other tissues were ≤ 3x background. Based on these data oral absorption was estimated to be 80% over the 72-hour period with > 99% of excreted in the urine and 0.3% eliminated in expired CO₂with only 0.2% in the tissues and carcass. The assessment of billiary elimination was beyond the scope of the study.

After dermal application, the ADME of radiolabeled n-lauryl-glucose amide ([¹⁴C]-C₁₂-G5 Base; radiochemical purity 99.8%) was investigated in fasted male Sprague-Dawley rats. Following dermal administration of 9.9 mg/kg bw (0.26 mg/cm²) dose in ethanol, the material balance was 95 ± 5.0% (n=2). At the end of testing (72-hours), 94.4% of radioactivity was recovered at the test site skin (plus dose cell wash), 0.27% in the urine (plus cage wash), 0.19% tissue (plus carcass), 0.1% in the feces (plus gastrointestinal tract wash), and 0.02% in expired CO₂. Individual tissue distribution at 72 hours indicated low levels in all tissues with the highest levels in the femur (20x plasma radioactive content) followed by carcass, whole blood, adipose and bone marrow. All other tissues were ≤ 5x background. Based on these data dermal absorption was estimated to be <1% over a 72 hour test period, with the principal route of elimination being urine. The assessment of billiary elimination was beyond the scope of the study.