Registration Dossier
Registration Dossier
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EC number: 231-635-3 | CAS number: 7664-41-7
Exposure related observations in humans: other data
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:
- 1 973
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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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