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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary study in human volunteers

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1973

Materials and methods

Type of study / information:
Inhalation exposure by human volunteers
Endpoint addressed:
acute toxicity: inhalation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Inhalation exposure by human volunteers
GLP compliance:
not specified
Remarks:
: not relevant for this study type

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonia, anhydrous
EC Number:
231-635-3
EC Name:
Ammonia, anhydrous
Cas Number:
7664-41-7
Molecular formula:
H3N
IUPAC Name:
ammonia
Details on test material:
Ammonia

Method

Ethical approval:
not specified
Details on study design:
Ten human subjects were exposed for 5 minutes to concentrations of 32, 50, 72 or 134 ppm in a dynamic chamber.
Exposure assessment:
measured
Details on exposure:
Ten human subjects were exposed for 5 minutes to concentrations of 32, 50, 72 or 134 ppm in a dynamic chamber.

Results and discussion

Results:
Concentrations of 72 ppm or higher caused discomfort and probably would not be tolerated by some human subjects. Concentrations of 50 ppm or less could be tolerated for at least five minutes and probably much longer. The level of 50 ppm appeared to be below the threshold concentration causing discomfort. The results indicated irritation at 72 or 134 ppm with more irritation at the higher level. There was some dryness of the nose in one or two subjects exposed to 32 or 50 ppm, but there was not a definite irritation at these levels.

Any other information on results incl. tables

Concentrations of 72 ppm or higher caused discomfort and probably would not be tolerated by some human subjects. Concentrations of 50 ppm or less could be tolerated for at least five minutes and probably much longer. The level of 50 ppm appeared to be below the threshold concentration causing discomfort. The results indicated irritation at 72 or 134 ppm with more irritation at the higher level. There was some dryness of the nose in one or two subjects exposed to 32 or 50 ppm, but there was not a definite irritation at these levels.

Applicant's summary and conclusion

Conclusions:
Concentrations of 72 ppm or higher caused discomfort and probably would not be tolerated by some human subjects.
Executive summary:

Concentrations of 72 ppm or higher caused discomfort and probably would not be tolerated by some human subjects. Concentrations of 50 ppm or less could be tolerated for at least five minutes and probably much longer. The level of 50 ppm appeared to be below the threshold concentration causing discomfort. The results indicated irritation at 72 or 134 ppm with more irritation at the higher level. There was some dryness of the nose in one or two subjects exposed to 32 or 50 ppm, but there was not a definite irritation at these levels.