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:
1946
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study in human volunteers published in the peer-reviewed literature, with sufficient details provided on method and results.

Data source

Reference
Reference Type:
publication
Title:
Toxicity and hazard of diisobutyl ketone vapors
Author:
Carpenter CP, Pozzani UC, Weil CS
Year:
1953
Bibliographic source:
Arch Ind Hyg Occup Med 8: 377-381

Materials and methods

Endpoint addressed:
respiratory irritation
Principles of method if other than guideline:
The sensory response of humans to diisobutyl ketone vapors was investigated.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Exposure assessment:
measured

Results and discussion

Applicant's summary and conclusion

Conclusions:
Based on the results of this study it was estimated that a workroom atmosphere containing 50 ppm of diisobutyl ketone would be "satisfactory" if not ideal.
Executive summary:

The sensory response of humans to diisobutyl ketone vapors was investigated by Silverman et al. They estimated that 25 ppm of the ketone vapors was the highest concentration that man would consider "satisfactory" for an eight-hour exposure. An attempt to confirm Silverman's work was made by means of two male subjects, 25 and 32 years of age, who inhaled 50 ppm of diisobutyl ketone vapors for three hours.

The exposure chamber consisted of a 6.5 ft. (198 cm) cube through which the vapor-laden air was drawn under slight negative pressure at 900 liters per minute. The vapor concentration was checked every 5 minutes for the first one-half hour and every 15 minutes for the remaining two and one-half hours by means of an interferometer.

The subjects employed themselves during exposure in routine writing chores and in recording pulse rate and subjective symptoms. A transitory slight irritation of the eyes and nose was noticed by both subjects at the beginning of exposure. However, the vapor could be smelled and tased throughout the exposure. Both subjects noted no change in the taste of cigarettes smoked at the end of the experiment. There was no significant change in the pulse rate and the blood pressure of the subjects, and tests for urine sugar and albumin performed 1 hour and 24 hours after exposure were negative. In view of the absence of any appreciable discomfort and the negative results of the physiological tests, the two subjects estimated that a workroom atmosphere containing 50 ppm of diisobutyl ketone vapors would be "satisfactory" if not ideal.

Ten days later, the same two men and an additional male subject, 43 years of age, inhaled 100 ppm of diisobutyl ketone vapors for three hours. The experimental procedure as outlined above was followed, with the addition of a simple coordination test. Each of the three subjects drew six circles and six squares at the beginning, middle and end of the exposure period.

A slight irritation of the eyes and nose was noticed initially by all three subjects, but the sensation decreased somewhat during the exposure. The ketone could be "tasted" by two subjects in one hour, and a slight throat irritation was noticed by one subject in one and one-half hours. Slight lacrimation occurred in one subject, and a slight headache was noticed by the other two subjects in two hours. Two subjects experienced a slight dizziness upon entering a fresh-air atmosphere after a three-hour exposure. The two subjects who smoked cigarettes after the exposure complained of an unpleasant taste. Pulse rates and blodd pressures were normal, and urinanalyses gave negative results. The performance of the subjects in the coordination tests was not influenced by the exposure. The subjects estimated that a working atmosphere of 100 ppm of diisobutyl ketone vapors would be "unsatisfactory".