Registration Dossier

Toxicological information

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
Study period:
April - August 1942
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: relatively old publication with limited information

Data source

Reference
Reference Type:
publication
Title:
Sensory response to certain industrial solvent vapors
Author:
Nelson KW, Ege JF, Ross MJ, Woodman LE & Silverman L
Year:
1943
Bibliographic source:
Journal of Industrial Hygiene and Toxicology 25: 282-285

Materials and methods

Type of study / information:
Inhalation experiment in human subjects
Principles of method if other than guideline:
The object of the experiment was to evaluate on humans the effects of some common solvent vapour concentrations. It was thought that the information gained could then be used as a valuable supplemental to present industrial experience. The solvents studied included hydrocarbons, alcohols, ketones, esters and ethers. The ketone group included butanone.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butanone

Method

Details on exposure:
The experiment consisted of the exposure in a 1200 cubic foot gas cabinet of an average number of 10 people of both sexes to a given concentration of solvent vapour for a period of 3 to 5 minutes. After the exposure, each individual classified the effect of the vapour on the eyes, nose and throat. The classifications were: no reaction, slightly irritating and very irritating. The odour was reported as absent, definite, moderate, strong or overpowering. Finally all persons were asked if they believed they could work in the atmosphere for an 8 hour day. The subjects, except the experimenters were not told of the actual concentrations and whether or not the exposures to any one solvent were in order of increasing or decreasing concentration

Results and discussion

Results:
Butanone produced slight nose and throat irritation at 100 ppm. Mild eye irritation appeared in some subjects at 200 ppm. 300 ppm was conclusively rejected. A practical limit of 200 ppm is indicated (see table 1)

Any other information on results incl. tables

Table 1: Sensory limits obtained for butanone

Solvent

Highest concentration which majority of subjects estimated satisfactory for 8-hour exposure

ppm

Concentration or vapour which irritated majority of subjects

Eyes

ppm

Nose

ppm

Throat

ppm

Butanone

200

350

350

350

Applicant's summary and conclusion

Conclusions:
A sensory limit of 200 ppm of butanone is considered to be acceptable in providing comfortable working conditions.