Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: longterm exposure measurement
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
A Ten-Year Study of Butyl Alcohol Exposure
Author:
Sterner J.H. et al.
Year:
1949
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 10: 53-59

Materials and methods

Type of study / information:
Long term study on n-butyl alcohol exposure to workers of a baryta coating operation unit
Endpoint addressed:
skin irritation / corrosion
eye irritation
Principles of method if other than guideline:
10 year study on n-butyl alcohol exposure to workers of a baryta coating operation unit. Repeated measurements of environmental factors, absentee data, and clinical examinations of the exposed individuals were investigated.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Details on study design:
A study has been made over 10-year period of an n-butyl alcohol exposure in a baryta coating operation, with repeated measurements of environmental factors, absentee data, and clinical examinations of the exposed individuals.
The interferometric method used for determining butyl alcohol in this study has been checked repeatedly, both as to the efficiency of collecting the sampIe and the final determination. A measured amount of air containing the butanol vapor is passed through silica gel in "U" tubes. The silica gel is then transferred to a glass-stoppered distillation apparatus, water is added, and the butyl alcohol-water solution distilled into a receiver in an ice bath. The distillate is made up to a known volume and the readings made in a Zeiss liquid interferometer, previously calibrated with known butanol solutions. The concentration in the air sampIe is then readily calculated.
Exposure assessment:
measured
Details on exposure:
At the start of this study 16 individuals were exposed to the vapors of butanol as baryta coaters. The number increased to a maximum of 99 at the time of the 1946 sampling. The original 16 were followed as a group so long as they continued on the coating operation. By 1946 only 10 of this group remained as "coaters," and at present only four are employed in this capacity.

Results and discussion

Results:
The physical examinations of employees exposed to butyl alcohol have been negative for any signs which could be related to exposure with the exception of eye irritation associated with the higher concentrations (averaging 200 ppm) encountered during the earlier period covered by this study. Since the exposure level has been reduced to 100 ppm, there have been very few complaints of irritation - and those were associated with short runs of coating types where the concentration frequently exceeded 100 ppm. In these mild cases the symptoms were of short duration (a few hours at the most) and· examination of the conjunctiva and cornea showed only slight edema.
X-rays of the lungs did not revealed any findings.
In no instance, clinical chemistry data, except one, were significantly different from the plant normal. This was the· initial mean erythrocyte count value, obtained on the group of 15 "original exposed" employees. Since the hemoglobin and cell volume mean values were"normaI," and since the subsequent erythrocyte mean values were within the limits of normal, the significance of this one deviation is not clear.
No systemic effects have been observed.

Any other information on results incl. tables

Initially, the results exceeded an average of 200 ppm, but these were reduced by lowering the concentration of butanol in the coating suspension and by the introduction of additional ventilation to an average, over the study period, of about 100 ppm.

Applicant's summary and conclusion