Registration Dossier

Administrative data

epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication.

Data source

Reference Type:
Olfactory Function in Chemical Workers Exposed to Acrylate and Methacrylate Vapors.
Schwartz BS et al.
Bibliographic source:
Am. J. Public Health. 79: 613-618

Materials and methods

Study type:
other: cross sectional study and case control
Endpoint addressed:
respiratory irritation
Principles of method if other than guideline:
An investigation of the olfactory function of 731 workers at a chemical facility which manufactures acrylate and methacrylates was undertaken using a standardized quantitative test.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl acrylate
EC Number:
EC Name:
Butyl acrylate
Cas Number:
Molecular formula:
butyl prop-2-enoate
Test material form:
other: liquid


Type of population:
Details on study design:
Study Population:
The study population consisted of all employees at a large manufacturing facility of the Rohm and Haas Company. The plant employs 909 workers in a variety of job activities and manufactures a number of chemicals, including acrylic acid and a variety of acrylates and methacrylates (especially ethyl acrylate, butyl acrylate, and methyl methacrylate).

Data Collection:
The testing consisted of administrating the University of Pennsylvania Smell Identification Test (UPSIT), a questionnaire contained within the UPSIT, and a brief questionnaire to obtain shift and job information. The test questionnaire obtained information on these study variables: age, gender, ethnic group, smoking history and dose, educational level, history of medical problems (self-reported problems which required treatment), history of smell or taste dysfunction, current medications, and work shift information.

Study Design:
A cross-sectional (prevalence) study of olfactory function in chemical workers was undertaken which considered only current jobs and exposures. In addition a nested case-control study was performed to assess the cumulative effects of the chemicals of interest on olfactory function.
Details on exposure:
In the cross-sectional study, workers were classified into one of four exposure categories based on current job only:
• no significant chemical exposures (N = 319),
• exposure to chemicals other than acrylic acid. Methacrylic acid, acrylates or methacrylates (N = 193),
• exposure to lower levels of acrylic acid, methacrylic acid, acrylates, or methacrylates (N = 164) and
• exposure to higher levels of acrylic acid, methacrylic acid, acrylates, or methacrylates (N = 55).

In the case-control study, exposure was studied in three ways:
• Exposure expressed as "never" or "ever" employed in job category 3 or 4 above for at least six weeks,
• the total duration of employment at the plant analyzed as a continuous variable; and
• a cumulative exposure score for each worker analyzed as a continuous variable. The cumulative score was calculated by classifying each job title the worker ever held into one of the four exposure categories outlined above, multiplying the duration of time employed in each job title by the score for that job title and adding these for all job titles ever held at the plant. The first two categories-no exposure and other chemical exposure-were assigned a score of zero, the lower acrylate/methacrylate category a score of one, and the higher acrylate/methacrylate category a score of two.
Statistical methods:
Data analysis was performed on a microcomputer with the BMDP Statistical Software program.

Results and discussion

In a cross-sectional analysis of the data, no associations of chemical exposure with olfactory test scores were observed.

A nested case control study revealed elevated crude exposure odds ratios (95% confidence interval) of 2.0 for all workers and 6.0 for workers who never smoked cigarettes. Logistic regression analysis adjusting for multiple confounders revealed exposure odds ratios of 3.8 and 13.5 in these same groups, respectively, and a dose response relationship between olfactory dysfunction and cumulative exposure scores-semi-quantitative indices of lifetime exposure to the acrylates.

Any other information on results incl. tables

The data revealed decreasing exposure odds ratios with increasing duration since last exposure to these chemicals suggesting that the effects may be reversible.

Applicant's summary and conclusion