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EC number: 204-340-2 | CAS number: 119-64-2
Area under the curve (AUC) (µg*h/mL)
15 mg/kg bw
0.78 mg/L (36 min)
0.62 mg/l (34 min)
0.76 mg/L (30 min)
1.35 mg/l (29 min)
50 mg/kg bw
2.57 mg/L (99 min)
1.04 mg/l (90 min)
3.46 mg/L (43 min)
3.14 mg/l (84 min)
150 mg/kg bw
19.01 mg/L (30 min)
5.54 mg/l (31 min)
9.64 mg/L (30 min)
12.02 mg/l (88 min)
Maximum concentrations of first sampling males > females Maximum concentrations of second sampling females > males => The tetrahydronaphthalene blood concentration maximum was reached
approximately 30 minutes after administration of the highest dose. AUC of second sampling always lower with males, higher with females as
compared to first sampling => The AUC of the high dose groups is more than proportional higher than that
of the lower dose groups indicating that elimination may be saturated at this dose level. An accumulation of test substance after
repeated oral administration of up to 150 mg/kg body weight was, however, not observed. FIRST ORDER HALF LIVES OF ELIMINATION (1 compartment model) high dose, male: 82.2 min reversal, male: 99.5 min high dose, female: 80.8 min reversal, female: 85.0 min FIRST ORDER HALF LIFE OF ELIMINATION (2 compartments model) ca. 4.7 hours (males) => After 23 hrs, only traces of test substance were detectable in the blood. The elimination half life was determined in the range
of 30 to 100 minutes. In the low and mid dose groups, elimination was almost finished after 6 hours. OTHER / GENERAL OBSERVATIONS: Dark coloured urine was observed in all treated animals. Tox. behaviour: see chapter 5.4
The present study describes the kinetics of tetrahydronaphthalene in male and female rats (five animals per dose per sex) at three dose levels (15, 50, and 150 mg/kg daily). Plasma concentration measurements were performed in the course of a subacute toxicity study of 28 days duration in an enriched study design. Two blood samples per animal were taken at different time points after application at day 1 and 16 (150 mg/kg daily) and at day 3 and 18 (15 and 50 mg/kg daily), respectively. Tetrahydronaphthalene was assayed by gas chromatography-mass spectrometry (GC-MS) after extraction. The data of plasma concentration time were analysed using non-linear mixed effects modelling as implemented in NONMEM. The structural model with the best fit employed one compartment kinetics with instantaneous drug input. Interindividual variability in both k and V was found to be very small [k, 0.201 h(-1), 0.013; V, 16.19 (kg), 1.77; population mean and SE]. No unequivocal evidence of dose dependence could be found. The kinetic parameter with the highest extent of variability was the extent of bioavailability which showed an coefficient of variation (CV) of 96%. Both gender and dose had no influence on the variability. The results of this study indicate that tetrahydronaphthalene is rapidly absorbed from the gastrointestinal tract and also rapidly excreted. Upon repeated application by gavage resorption was delayed at the highest dose level. There appears to be no induction of elimination upon repeated dosing. At higher dose level elimination is apparently saturated.
There was no accumulation upon repeated oral application of tetrahydronaphthalene up to 150 mg/kg bw.
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