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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Endpoint addressed:
respiratory irritation
Principles of method if other than guideline:
Adult volunteers were exposed to 25 ppm (75 mg/m3) diethylamine in a climate chamber for 15 min in order to study the acute nasal reactions to an exposure equivalent to the present threshold limit value-short-term exposure limit. Changes in nasal volume and nasal resistance were measured by acoustic rhinometry and by rhinomanometry. In a subsequent experiment, individuals were exposed to increasing concentration from 0 to 12 ppm for 60 minutes.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethylamine
- Analytical purity: >99.5 %

Method

Ethical approval:
other: Subjects participated in the study after giving informed consent according to the Helsinki declaration.
Details on study design:
7 healthy individuals (1 female and 6 males) aged 24 to 54 years and having no overt nasal abnormalities or allergic diseases as indicated by medical history served as study subjects. 4 participated in the 15-min experiment and another five in the 60-min experiment. All were nonesmokers and none wore contact lenses.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE:
- acute exposure for 15 min to 25 ppm (75 mg/m3)
- exposure for 60 min to increasing concentrations from 0 to 12 ppm , equal to an average concentration of 10 ppm (30 mg/m3)

TYPE OF EXPOSURE MEASUREMENT: continuously monitoring by a MIRAN 1A infrared gas analyzer

EXPOSURE LEVELS: 75 and 30 mg/m3; the concentration levels in the respiratory zone of the subjects showed a deviation of less than +/- 5 %

EXPOSURE PERIOD: 15 min and 60 min (experiments were carried out on separate days)

Results and discussion

Results:
In the subjects, that were exposed to 25 ppm (75 mg/m3) of the test substance for 15 min, neither changes in nasal volume, usually seen as acute nasal mucosa response to thermal stimuli was observed, nor acute change in nasal airway resistance.
A moderate to strong olfactory response and distinct nasal and eye irritation were observed in subjects exposed to increasing concentrations from 0 to 12 ppm (average 10 ppm = 30 mg/m3) for 60 min.

Any other information on results incl. tables

Subjective judgements of odor perception and nose and eye irritation displayed large differences in individual sensitivity and tolerance at the same time.

Applicant's summary and conclusion

Conclusions:
Neither changes in nasal volume was observed, nor acute change in nasal airway resistance. A moderate to strong olfactory response and distinct nasal and eye irritation were observed in subjects exposed to increasing concentrations from 0 to 12 ppm (average 10 ppm = 30 mg/m3) for 60 min.
Executive summary:

Adult volunteers were exposed to 25 ppm (75 mg/m3) of the test substance in a climate chamber for 15 min in order to study the acute nasal reactions to an exposure equivalent to the present threshold limit value-short-term exposure limit. Changes in nasal volume and nasal resistance were measured by acoustic rhinometry and by rhinomanometry. In a subsequent experiment, individuals were exposed to increasing concentration from 0 to 12 ppm for 60 minutes (average concentration of 10 ppm).

In the subjects, that were exposed to 25 ppm (75 mg/m3) of the test substance for 15 min, neither changes in nasal volume, usually seen as acute nasal mucosa response to thermal stimuli was observed, nor acute change in nasal airway resistance. A moderate to strong olfactory response and distinct nasal and eye irritation were observed in subjects exposed to increasing concentrations from 0 to 12 ppm (average 10 ppm = 30 mg/m3) for 60 min.