Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Comparative Effects of Ethanol , n-Propanol add Isopropanol on Lipid Disposal by Rat Liver
Author:
Beaugé F., Clement M., Nordmann J., Nordmann r
Year:
1979
Bibliographic source:
Chem.-Biol. Interactions, 26, 155-166

Materials and methods

Objective of study:
absorption
metabolism
Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 417 (Toxicokinetics)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes
Remarks:
C14

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses / concentrations
Dose / conc.:
3 005 mg/kg bw/day (nominal)
No. of animals per sex per dose:
3

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The propan-1-ol concentration in blood serum peaked one hour after administration. a peak blood level of approximately 1800 mg/l after about 1.5 hours could be derived. Thereafter blood levels decreased rapidly to below detection limits (5 h after dosing)

The rate of metabolism of n-propanol was 510 mg (8.5 mmol)/kg/h.

Applicant's summary and conclusion