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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles, acceptable for assessment but without detailed documentations

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Further studies on sensory response to certain industrial solvent vapors
Author:
Silverman L, Schulte HF, First MW
Year:
1946
Bibliographic source:
J Ind Hyg Toxicol., 28: 262-266
Reference Type:
publication
Title:
Sensory Response to Certain Industrial Solvent Vapor
Author:
Nelson KW, Ege JF, Ross M, Woodman LE and Silverman L
Year:
1943
Bibliographic source:
J Ind Hyg Toxicol., 25, 282-285

Materials and methods

Endpoint addressed:
eye irritation
respiratory irritation
Principles of method if other than guideline:
Exposure of 12 male and 12 female test persons to diacetone alcohol vapour in a concentration of 100 ppm (approximates the saturation concentration at 25°C) for 15 minutes.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Technical grade solvent supplied by the Shell Development Company, Emeryville, California

Method

Ethical approval:
not specified
Exposure assessment:
not specified
Details on exposure:
The experimental procedure was similar to that described by Nelson et al., (1943). An average number of twelve subjects of both sexes were used for each solvent exposure. The procedure used previously was modified as follows: 1) The time of exposure was increased to fifteen minutes. This period permitted more accurate observation of olfactory fatigue and a better appraisal of increasing or decreasing irritation of mucous membranes. 2) During the 15 minute exposure period, motion pictures were shown te occupy the subjects' attention and divert their thoughts from the atmospheric contamination to which they were expose.

Results and discussion

Results:
Eye irritation appeared in the majority of subjects at 100 ppm, and at this concentration practically all subjects complained of irritation to eyes, nose, or throat. The majority of subjects found the odor unpleasant at 100 ppm and many complained of an unpleasant taste. AIthough the majority of subjects indicated that they could work an 8 hour day in 100 ppm, 50 ppm appears to be a more reliable limit. This is justified because of the variety and number of complaints evoked at 100 ppm.

Any other information on results incl. tables

SENSORY LIMITS OBTAINED ON SOLVENT VAPORS

Solvent

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

ppm

Concentrationofvapour which irritated majority of subjects

Suggested maximum allowable concentrations

ppm

Eyes

ppm

Nose

ppm

Throat

ppm

Diacetone alcohol

50

100

>100

>100

None

Applicant's summary and conclusion

Conclusions:
Diacetone alcohol is irritating for the respiratory tract.
Executive summary:

12 subjects of both sexes were exposed by inhalation to 100 ppm DAA (equivalent to 483 mg/m3) for 15 minutes. The majority of them found the odour and taste objectionable and complained about eye, nose and throat irritation although they indicated that they could work an 8 hour-day in 100 ppm.