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
Principles of method if other than guideline:
Exposure of 12 male and 12 female test persons to hexylene glycol vapour in a concentration of 50 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:
A maximum allowable limit has not been determined previously A majority of subjects found HG irritating to the eyes at 50 p.p.m., which is approximately saturation concentration at room temperature (25° C.). HG a weak odor and, except for slight irritation of the eyes, there appears to be little objection to it at the highest concentrations possible as a vapor at room temperature.

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

Concentration of vapour which irritated majority of subjects

Suggested maximum allowable concentrations

ppm

Eyes

ppm

Nose

ppm

Throat

ppm

Hexylene glycol

50

50

>50

>50

None

Applicant's summary and conclusion

Executive summary:

Exposure of 12 male and 12 female test persons to hexylene glycol vapour in a concentration of 50 ppm (approximates the saturation concentration at 25°C) for 15 minutes caused eye irritation in most of the persons but no irritation of the nose or throat. The maximum tolerable concentration was considered to be 50 ppm.