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EC number: 701-175-2
CAS number: -
PRIMENE™ 81-R (Amines, C10-C14-tert-Alkyl) is a mixture containing major
components with alkyl carbon number ranged from C10 to C14. Experimental
data on oral absorption in rats either from single or repeated oral
exposures (such as repeated 90-day dietary exposure) is not available
for this mixture. Therefore, the oral bioavailability, other major
pharmacokinetic parameters, and metabolic clearance data of the major
representative 20 components of the mixture were estimated via the
widely accepted QSAR programs, ADMET predictor (v9.5, Simulations Plus
Inc, Lancaster, CA, USA), and GastroPlus (v9.7, Simulations Plus Inc,
Lancaster, CA, USA).
Using the parameters for a repeated 90-day oral dietary exposure to a
fed rat (0.25 kg) at dose level of 107 mg/kg/day (mkd), the predicted
fractional absorption (Fa%), bioavailability (F%), and maximum
steady-state plasma concentration (Css ), area under curve (AUC) values,
and rat liver microsomal clearance (CYP-RLM-CLint) of the representative
20 components by GastroPlus were determined.
Overall, the predicted Fa%, F%, Css, AUC, and CYP-RLM-CLint for these
major components were in the ranges of 97.60-99.81%, 16.10-34.97%,
0.646-1.092 μg/mL, 493-999 μg.h/mL, and 196.602-435.343 μl/min/mg RLM
According to the predicted values of Fa%, F%, Css, and AUC, all these
representative components of PRIMENE 81-R are bioavailable in rats, and
the predicted CYP-RLM-CLint values indicate that all these
representative components can be metabolized via cytochrome p450 (CYP).
The predicted plasma time-courses of the representative components
indicated no apparent bioaccumulation of any of the representative major
components of PRIMENE 81-R upon repeated-day exposures at the dose level
of 107 mkd.
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