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Epidemiological data

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epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable, well-documented study. Limitations in design/reporting but adequate for assessment.

Data source

Reference Type:
Report date:

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
Principles of method if other than guideline:
A mortality analysis was performed in 186 men assigned to glutaraldehyde production from its start-up in 1959 through 1978, at a chemical plant in West Virginia and compared to US white males and 29000 chemical workers.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
Specific details on test material used for the study:
- Name of test material (as cited in study report): Glutaraldehyde


Type of population:
Ethical approval:
not applicable
Details on study design:
The cohort consisted of 186 men assigned to the glutaraldehyde production unit (GPU) from 1959 to 1978. These individuals were identified from work assignment information contained in the National Institute of Occupational Safety and Health/Union Carbide Corporation (UCC) mortality study of over 29,000 workers in the Kanawha Valley (KV) of West-Virginia. They were also a subset of UCC's ethylene oxide (EO) worker study, since these same operators were involved in the production of certain EO derivatives.

The vital status observation period was January 1, 1959 to December 31, 1983. Traditional Standardized Mortality Ratio (SMR) analyses, were conducted, using U.S. mortality rates for white males through 1988 for calculation of expected deaths. 10 Person years were calculated from first assignment to the GPU (after Dec. 31, 1958) to the date last observed. SMRs (observed/expected) were examined by time since first exposure and duration of assignment. In addition to external comparisons to the U.S. population, internal comparisons using the men from the KV cohort never assigned to the GPU as a referent group, were also conducted.
Exposure assessment:
not specified

Results and discussion

Vital Status was ascertained for 181 (97.3%) study subjects and death certificates were available for all decedents. There were 14 deaths (7.5%) among the 186 study subjects. Race data were unavailable for 53 subjects. There were 125 known white and 8 known nonwhites in the study group. More than 50% of the cohort was first assigned to the GPU within the first five years of glutaraldehyde production and all subjects were observed at least 10 years with an average time since first exposure of 20.6 years. The average duration of assignment to the unit as of 1/1179 was 3.7 years.

There was a statistically significant deficit of deaths due to all causes with 14 observed and 25.4 expected (95% CI: 0.3, 0.9). The rate for total malignant neoplasms was also less than expected, with 4 cancer deaths versus 6.1 expected (SMR = 0.65). The cancer SMR was lower (0.52) for those who worked five years or more in the unit. The four cancers included one each due to stomach, lung and brain and a death due to lymphosarcoma, the only cancer death among those who worked more than 5 years in the production of glutaraldehyde. The number of cancer deaths expected among those assigned over 5 years was 1.9. The results of the internal comparisons of the glutaraldehyde workers to the remaining KV workers were consistent with those observed based on U.S. comparisons. There were no excess deaths due to all causes or total malignancies.

Applicant's summary and conclusion