Sodium ethanolate

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Acceptable, study with sufficient basic documentation to demonstrate that study meets basic scientific principles and contains enough detail to be able to judge the results reliable as a contribution to the understanding of the background exposure to this substance.

Data source

Reference

Reference Type:

publication

Title:

On the problem of endogeneous alcohol. Endogenous ethanol: Further investigations (in German)

Author:

Sprung, R., Bonte, W., Rudell, E., Domke, M., Frauenrath, C.

Year:

1981

Bibliographic source:

Alcohol Drugs Behav. 18(2):65-70.

Materials and methods

Study type:

other: measurement of endogenous (background) blood concentrations of substance

Endpoint addressed:

not applicable

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Measurement of background blood concentrations of ethanol in subjects that had not consumed alcohol over the previous 24 hours.

GLP compliance:

not specified

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:

not applicable

Method

Type of population:

general

Subjects:

MAIN STUDY
- Number of subjects: 130
No further data

SATELLITE STUDY 1
- Number of subjects: 10
No futher data

SATELLITE STUDY 2
- Number of subjects: 30
- Known diseases: subjects under treatment for metabolic diseases, including diabetes, hepatitis, cirrhosis of the liver, pancreatitis, hyperlipidaemia.

Ethical approval:

not specified

Route of exposure:

other: endogenous exposure

Reason of exposure:

other: endogenous exposure primarily from the action of intestinal microflora

Exposure assessment:

measured

Details on exposure:

not applicable

Examinations:

- Other: blood ethanol concentrations. Samples taken with a 'Koller venule' with the addition of NaF. Blood alcohol levels were determined with a 2-column chromatograph and headspace technique - details given in a separate reference (Bonte W, 1981 - unpublished at time this study was published).

Results and discussion

Results of examinations:

All of the individual measurement values are presented in the reference. From these it is possible to calculate that the endogenous ethanol range covering 95% of the general population is 0.062 to 0.73mg/l. Values seen in the two satellite groups were essentially the same, confirming that both the main group results were valid and that metabolic disturbances do not significantly alter background ethanol blood concentrations. The highest measured value was 0.748mg/l.

Applicant's summary and conclusion

Executive summary:

In a study of 130 human volunteers who had abstained from consuming alcohol for at least 24 hours, the background blood ethanol concentration covering 95% of the population was found to be 0.062 -0.73mg/l. The highest measured value was 0.748mg/l. Diseases associated with metabolic disturbance did not cause background ethanol concentrations to move outside this range.