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Toxicological information

Exposure related observations in humans: other data

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Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
other information

Data source

Reference
Reference Type:
secondary source
Title:
EU Risk Assessment Report, CAS No. 71-23-8: Propan-1-ol, Vol. 82
Author:
not applicable
Year:
2008
Bibliographic source:
ECB

Materials and methods

Endpoint addressed:
basic toxicokinetics
dermal absorption
Principles of method if other than guideline:
Summarized overview of available human data as given in the EU RAR 2008.

Test material

Constituent 1
Chemical structure
Reference substance name:
Propan-1-ol
EC Number:
200-746-9
EC Name:
Propan-1-ol
Cas Number:
71-23-8
Molecular formula:
C3H8O
IUPAC Name:
propan-1-ol

Results and discussion

Results:
see below.

Any other information on results incl. tables

DERMAL

The penetration through human skin was qualitatively demonstrated in volunteers: Rubbing hands and underarms for five minutes with propan-1-ol containing antiseptics (estimated amount propan-1-ol applied: 9-15 g) resulted in peak levels in blood taken from a foot vein from 0.2 to 0.4 mg/l (Peschel et al., 1992).

 

Oral

In studies with human volunteers ingesting orange juice containing alcohols (5 mg/kgbw propan-1-ol and 0.8 g /kgbwethanol) blood levels of propan-1-ol peaked 15 minutes after the ending of the drinking period (30 or 60 minutes), indicating a rapid absorption from the GI tract (Bilzer et al., 1990). Schmutte et al. (1988) could not detect propan-1-ol in the blood of 9 from 10 volunteers

within 15 min after finishing drinking (16 whole blood samples/person, gas-liquid chromatography) of propan-1-ol doses in water of up to 12.5 mg/kg, probably due to a significant 'first pass' effect.

For evaluating the concentration of propan-1-ol in saliva, drinking test was performed with 10 test persons. The alcoholic drink was wine. During thetest ,the test persons each received 1 g ethanol (given equivalent as wine) /kg bw for 1 hour and the quantities of other alcohols, naturally contained in the beverage. Propan-1-ol concentrations in saliva were found to be up to 4 to 5 times higher than those in blood after the consumption of wine (Hein et al., 1989).

 

OTHER

Wehner and Schieffer (1989) administered doses of 25, 50, 100, 200, and 300 mg propan-1-ol intravenously to one male (bw69 kg) and one female (bw 72 kg) volunteer. Based on a three compartment open system model and a non-linear elimination process controlled by Michaelis-Menten kinetics the authors calculated a Michaelis-Menten constant (Km) of approximately 10 mg/l and a maximal initial velocity of metabolism (Vmax) of 2.5 mg/l/min.

Tissue-gas partition coefficients were determined for propan-1-ol using head-space methods. Human tissues were obtained by autopsy. Blood and several representative tissues were examined: blood (866 + 55), muscle (651 + 28), kidney (713 + 33), lung (698 + 37), brain gray (749 + 23) ,fat (287 + 8). For liver a tissue-gas partition-coefficient of 564 was calculated. The solvent tend to be more soluble in plasma (969 + 60) than in erythrocytes (799 + 99). It has been shown that solubility of propan-1-ol not increases with lipid content in blood and tissues (Fiserova-Bergerova and Diaz, 1986).

Permeation rates (flux) of pure liquid propanol and aqueous solutions of propan-1-ol,

respectively, were determined in a diffusion cell using abdominal skin from human adults:

through epidermis - 96 μg/cm²/h vs. 6 μg/cm²/h (Scheuplein and Blank, 1973).

Applicant's summary and conclusion