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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, non guideline human experimental study, published in the peer reviewed literature, minor restrictions in design but otherwise adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The pharmacokinetics of ethylene in healthy human volunteers was determined following inhalation exposure.
GLP compliance:
not specified

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:
Ethylene, purity >99.95% was supplied by Messer Griesheim, Dusseldorf, FRG.

Method

Type of population:
general
Subjects:
A total of 14 healthy volunteers, 8 males and 6 females, 22-65 years were recruited; 6 volunteers were used for inhalation experiments and all 14 for exhalation experiments.
Ethical approval:
not specified
Route of exposure:
inhalation
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
Volunteers were exposed individually using a breathing mask connected to a modified spirometer. Initial ethylene concentrations were 5 and 50ppm.
Examinations:
Ethylene concentrations in the atmosphere were measured by gas chromatography during exposure for up to 2 hours (inhalation experiment); exhalation of expired endogenous ethylene was measured for up to 2.5 hours while volunteers breathed synthetic air (exhalation experiment). N-(2-hydroxyethyl)-valine adducts of haemoglobin were measured by GC-MS.

Results and discussion

Results of examinations:
Metabolism of ethylene in human volunteers was not saturated at concentrations up to 50 ppm. In human volunteers, the endogenous production rate of ethylene was 32±12 nmol/h; the half life of ethylene was 0.65±0.14 h. Alveolar retention of inhaled ethylene was 2±0.8%. Background levels of adducts in non-smokers were due to a combination of endogenous ethylene (~67%) and background concentrations (15 ppb) in air (~33%).

Applicant's summary and conclusion