Registration Dossier
Registration Dossier
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EC number: 201-280-9 | CAS number: 80-46-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
Data source
Reference
- Reference Type:
- publication
- Title:
- Dose-dependent shifts in the sulfation and glucuronidation of phenolic compounds in the rat in vivo and in isolated hepatocytes. The role of saturation of phenolsulfotransferase.
- Author:
- Koster, H., et al.,
- Year:
- 1 981
- Bibliographic source:
- Biochem Pharmacol, 1981. 30(18): p. 2569-75.
Materials and methods
Test material
- Reference substance name:
- Para-tert butylphenol
- IUPAC Name:
- Para-tert butylphenol
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- other: aqueous saline
- Duration and frequency of treatment / exposure:
- Single dose injection
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8, 15, 28 and 68 μmol/kg
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Total recovery in bile and urine 91-93% of the administered dose.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Between 65-71% and 17-21% of the applied dose were excreted as glucuronide and sulfate conjugates, respectively.
(At 8, 15, 28 and 69 μmol/kg the excretion of Glucuronide was 68 ±7%, 65 ± 4%, 71 ± 3% and 67 ± 3%, respectively.
At 8, 15, 28 and 69 μmol/kg the excretion of Sulphate was 21 ±8%, 29 ± 4%, 17 ± 3%, and 29 ± 4%, respectively).
Applicant's summary and conclusion
- Executive summary:
Para-tert-ButylPhenol is rapidly metabolised and excreted as conjugates in urine. Radiolabelled P-t-ButylPhenol was given intravenously to Wistar rats (single dose 1.2-10.4 mg/kg bw) and bile and urine were collected for four hours.
Total recovery was 91-93% of which 65-71% was excreted as glucuronide conjugate, 17-21 % as sulphate conjugate.
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