Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: Efficacy in clinical use as an anaesthetic
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Information from publication, reliability not known but contributing to a weight of evidence assessment.

Data source

Reference
Reference Type:
publication
Title:
The present status of ethylene-oxygen anesthesia
Author:
Livingstone HM
Year:
1945
Bibliographic source:
Ann Surg, vol 122 pp 1071-1085

Materials and methods

Type of study / information:
A review of physiological and pharmacological effects following surgery under ethylene-oxygen anaesthesia.
Endpoint addressed:
acute toxicity: inhalation
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Evaluation of the clinical findings following anaesthesia with ethylene.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene
EC Number:
200-815-3
EC Name:
Ethylene
Cas Number:
74-85-1
Molecular formula:
C2H4
IUPAC Name:
ethylene
Details on test material:
- Name of test material (as cited in study report): ethylene
- Physical state: colourless gas
- Substance type: unsaturated hydrocarbon gas
- Molecular weight: 28
- Specific gravity: 0.97
- Boiling point: -103°C
- Liquefies: 10°C under 60 atmospheres
- Flash point: below 32°F
- Analytical purity: Compressed in cylinders 99.5 - 99.9% purity

Method

Ethical approval:
not applicable
Details on study design:
An evaluation of the clinical findings following exposure to ethylene-oxygen as the anaesthetic to 3210 hospital patients. Administration of 80% ethylene and 20% oxygen, reported to be a good anaesthetic whilst providing adequate oxygen for patients.
Exposure assessment:
not specified
Details on exposure:
TYPE OF EXPOSURE:
Controlled use as an anaesthetic in hospitals during surgical procedures. Premedication with morphine sulfate or calcium nembutal was administered prior to anaesthesia.

TYPE OF EXPOSURE MEASUREMENT: no data.

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: The patients were classified by age and by preoperative assessment of risk.

Results and discussion

Results:
Induction of anaesthesia with 80:20% ethylene:oxygen mixture was rapid. The authors report no increase in mucous secretions or sign of irritation in the pulmonary endothelium. Respiration rate may increase or become irregular during the induction of anaesthesia. Death is due to asphyxia but low incidences of mortality are reported, overall post-operative mortality was 1.5%; none of the deaths were considered to be directly due to the anaesthetic agent used. Incidences of postoperative nausea and/or vomiting occurred only on the day of surgery.

Any other information on results incl. tables

Ethylene was shown to be an effective anaesthetic, relaxation is considered moderate but was deficient in providing deep abdominal relaxation. Anaesthesia was reported to be achieved rapidly and calmly. There was no increase in mucus secretions or irritation of the pulmonary endothelium (Cotyllos Pol N and Birnbaum GL, Studies in pulmonary gas absorption in bronchial obstruction. Am.J.Med.Sc., 183, 317-359, 1932). Postoperative nausea and/or vomiting that occurred were considered to be due to the combined effects of anaesthetic and morphine.

Applicant's summary and conclusion

Conclusions:
Ethylene-oxygen was an effective anaesthetic with few adverse clinical effects. Anaesthesia is induced by concentrations of 80% ethylene, 20% oxygen.
Executive summary:

The clinical findings following surgery under ethylene-oxygen anaesthesia were assessed in patients. There were few side-effects and recovery from anaesthesia was rapid. Anaesthesia is induced by concentrations of 80% ethylene, 20% oxygen. Equivalent dose 800000ppm or 917857 mg/m3 or 917 mg/L.