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Exposure related observations in humans: other data

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

Data source

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

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:
EC Number:
EC Name:
Cas Number:
Molecular formula:

Results and discussion

see below.

Any other information on results incl. tables


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).



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).



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