Registration Dossier
Registration Dossier
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EC number: 203-561-1 | CAS number: 108-21-4
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:
- key study
- Study period:
- 1946
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Original source documents reviewed. Data old but key scientific details recorded and work carried out using a sound methodology. There is no information provided on how vapour concentrations were determined.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Further studies on sensory response to certain industrial solvent vapours
- Author:
- Silverman, L., Schulte, H.F., First, M.W.
- Year:
- 1 946
- Bibliographic source:
- J. Ind Hyg and Toxicol, 28:262-266
- Reference Type:
- publication
- Title:
- Sensory Response to Certain Industrial Solvent Vapours
- Author:
- Nelson KW, Ege JF, Ross M, Woodman LE, Silverman L
- Year:
- 1 943
- Bibliographic source:
- J Ind Hyg Toxicol 25, 282-5
Materials and methods
- Type of study / information:
- Human sensory irritation
- Endpoint addressed:
- eye irritation
- respiratory irritation
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Study to evaluate the discomfortable sensory response but not necessarily toxic effects that result from exposure to solvent vapours. No attempt made to evaluate the effects of habituation (acclimatisation) to solvent exposure and subsequent reduction of subjective sensory response.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
Test material
- Reference substance name:
- Isopropyl acetate
- EC Number:
- 203-561-1
- EC Name:
- Isopropyl acetate
- Cas Number:
- 108-21-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- isopropyl acetate
- Details on test material:
- Source: Shell Development Company.
Vapour pressure: 47.5mmHg at 20C
Boiling point: 88.4C at 1 atm.
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- Volunteers
- Exposure assessment:
- estimated
- Details on exposure:
- TYPE OF EXPOSURE: Whole body exposure in a 1200 cu foot gas cabinet. Vapour concentrations produced by adding a stream of saturated vapour to the measured air being blown into the chamber.
TYPE OF EXPOSURE MEASUREMENT: no clear data. May be by estimation based on mass flow into cabinet.
EXPOSURE LEVELS: Not explicitly specified by exposures at and below 100ppm and at and above 200ppm were used
EXPOSURE PERIOD: 15 mins
NUMBER OF HUMAN VOLUNTEERS EXPOSED: 12 (males and females)
Results and discussion
- Results:
- At 200ppm, the majority of subjects experienced some degree of irritation (discomfort) to the eyes, nose and throat but not at 100ppm. There was little objection to the odour at 200ppm. The majority of volunteers indicted that an exposure to 100ppm would be tolerable over an extended (8 hour) period.
Applicant's summary and conclusion
- Executive summary:
Silverman et al (1946) reported in a very old study that the majority of twelve male and female volunteers reported eye, nose and throat irritation when exposed to 200 ppm isopropyl acetate for 15 minutes. The subjects reported that 100ppm would be tolerable for an 8 hour exposure period.
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