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Toxicological information

Exposure related observations in humans: other data

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Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable data

Data source

Referenceopen allclose all

Reference Type:
Odor and chemesthesis from exposures to glutaraldehyde vapor
Cain WS, Schmidt R, Jalowayski AA
Bibliographic source:
Int. Arch Occup. Environ. Health 80(8): 721-31
Reference Type:
study report
Report date:

Materials and methods

Type of study / information:
Assessment of olfactory and chemesthetic sensitivity (feel, sensory irritation) to vapour of glutaraldehyde in young adult females. For chemesthetic sensitivity, assessment included the variable of duration, with focus on whether concentrations initially too low to evoke feel in the eye or upper airway might do so in exposures up to 15 minutes.
Endpoint addressed:
not applicable
Principles of method if other than guideline:
Not applicable
GLP compliance:
not applicable

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
Specific details on test material used for the study:
- Name of test material (as cited in study report): Glutaraldehyde
- Physical state: liquid
- Analytical purity: The stimulus material consisted of glutaraldehyde (Fisher Certified, 26.1% by weight in water)
- Lot/batch No.: lot #001197
- Other: Odor: green apple


Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
Odor and chemesthesis from exposure to glutaraldehyde was tested in volunteer subjects (50 females, 18 -35 years, various ethnicity).
Exposure was brief (up to 5 sec. and 15 min. at concentrations of 0.039 to 4.95 ppb and 229 to 772 ppb for brief exposure and 35 to 100 ppb for 15 min. exposure.
Exposure assessment:
Details on exposure:
Experiment 1:
The first experiment probed sensitivity with forced-choice testing of detection over ranges of concentrations appropriate to three endpoints: odor, feel in the eye, and feel in the nose. A subject participated in hours of testing per endpoint to yield enough data to erect a psychometric (concentration-response) function. Exposure in Experiment 1 entailed use of a vapor-delivery system that stimulated sites of interest separately.

Exposure in Experiment 2 occurred in the ambient environment of a chamber, with the sites stimulated simultaneously. In that case, subjects rated confidence by the minute that they felt the presence of vapor in the eyes, nose, and throat during exposures of 15 minutes to 35, 50, 75, and 100 ppb, a blank, and an odor control of mild heptane.

Results and discussion

In Experiment 1, the typical subject achieved 50% detection (threshold) of odor at 0.3 ppb. The typical subject achieved 50% detection of feel in the eye and nose at 390 and 470 ppb, respectively. Psychometric functions for feel showed much sharper dependence on concentration than those for odor.
In Experiment 2, confidence in detection of feel migrated progressively away from no-with certainty toward the zone of uncertainty, with bigger change when the exposures contained any glutaraldehyde. The ratings of confidence failed, however, to show distinguish among these concentrations.

Applicant's summary and conclusion