Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study which meets basic scientific principles

Data source

Reference Type:
study report

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.

Test material

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


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:
Details on 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

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.

Applicant's summary and conclusion