Ethanol

Basic toxicokinetics

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:

other: Not a guideline study and not performed according to GLP, but data scientifically acceptable and well reported

Data source

Reference

Reference Type:

publication

Title:

Excretion of low-molecular weight volatile substances in human breath: focus on endogenous ethanol

Author:

Jones AW

Year:

1985

Bibliographic source:

J Anal Toxicol 9: 246-250

Materials and methods

Objective of study:

excretion

Principles of method if other than guideline:

To investigate the elimination kinetics of a small oral dose of exogenous ethanol in a healthy individual.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol

EC Number:

200-578-6

EC Name:

Ethanol

Cas Number:

64-17-5

Molecular formula:

C2H6O

IUPAC Name:

ethanol

Details on test material:

- Name of test material (as cited in study report): ethanol
- Physical state: Liquid
- Analytical purity: 99.6% v/v
- Other: Ethanol obtained from Vin och Spritcentralen Ltd

Radiolabelling:

no

Test animals

Species:

human

Sex:

male

Details on test animals or test system and environmental conditions:

One healthy volunteer

Administration / exposure

Route of administration:

other: oral

Vehicle:

other: diluted with orange juice

Details on exposure:

Volunteer drank 5 g of ethanol diluted to 100 mL with orange juice

Duration and frequency of treatment / exposure:

Single

Doses / concentrations

Remarks:

Doses / Concentrations:
0.077 g/kg bw

No. of animals per sex per dose / concentration:

1 male

Control animals:

no

Positive control reference chemical:

none

Details on dosing and sampling:

Breath sampling. The volunteer was instructed to take a moderately deep inhalation and to exhale as much breath as possible. At the end of exhalation a sample of breath was captured. This end-expired alveolar air was analysed with a model 104-gas chromotograph equipped with a flame ionization detector. A model 2091 mass spectrometer was used to record the mass spectra of endogenous ethanol. The blood:breath partition ratio for ethanol in vivo was taken as 2300:1.

Statistics:

no data

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:

Blood ethanol concentrations were estimated from breath analysis (end-expired alveolar air) of the healthy volunteer over time, following consumption of 5 g ethanol. Elimination kinetics showed that pre-drink endogenous blood ethanol levels (of about 0.07 to 0.39 µg/L; estimated from another experiment involving 10 healthy male volunteers) were increased about 200-fold following consumption of this low-dose of ethanol. The elimination of exogenous ethanol took just over 2 hr, with a half-life of about 16 minutes.

Metabolite characterisation studies

Metabolites identified:

not measured

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
When a healthy male volunteer drank 5 g ethanol (about 0.077 g/kg bw), the blood concentration of ethanol was estimated to have increased about 200-fold above the endogenous levels. The elimination of exogenous ethanol took just over 2 hours, with a half-life of about 16 minutes.

Executive summary:

Blood ethanol concentrations (assuming a blood:breath partition ratio in vivo of 2300:1) were estimated from breath analysis of a healthy male volunteer over time after consumption of 5 g ethanol (about 0.077 g/kg bw) diluted in orange juice, following an overnight fast.  Elimination kinetics showed that pre-drink endogenous blood ethanol levels (of about 0.07 to 0.39 µg/L; estimated from another experiment involving 10 healthy male volunteers) were increased about 200-fold following consumption of this low-dose of ethanol (about half a typical alcoholic beverage). The elimination of exogenous ethanol took just over 2 hr, with a half-life of about 16 minutes.