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Diss Factsheets

Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Correlation study of experimentally-determined air concentrations with worker symptoms as reported by questionnaire. Work environment consisted of exposure to a mixture of chemicals, so correlations with the registered substance only cannot be made.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Study type:
other: biological effect and biological exposure monitoring
Endpoint addressed:
repeated dose toxicity: inhalation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
This health hazard evaluation included environmental air measurements of epoxy powder concentrations, medical questionnaires, pulmonary function tests and skin patch tests.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
EC Number:
219-348-1
EC Name:
Benzophenone-3,3':4,4'-tetracarboxylic dianhydride
Cas Number:
2421-28-5
Molecular formula:
C17H6O7
IUPAC Name:
5-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl)-1,3-dihydro-2-benzofuran-1,3-dione
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
An epoxy powder containing 70% isopropylidene diphenol epichlorohydrin (resin) and 29% benzophenone tetracarboxylic dianhydride (hardener).

Method

Type of population:
occupational
Ethical approval:
not specified
Remarks:
NIOSH has internal ethics standards policy
Details on study design:
Preliminary Survey: during a preliminary survey of the epoxy powder spraying operations, eight samples of dust were collected and analysed. Twenty-two employees were interviewed about problems with their work environment. A follow-up survey was deemed necessary to be carried out.

An environmental and medical survey was conducted. Breathing zone and work area samples were collected using PVC filters and MSA vacuum pumps operating at 1.5 liters per minute. The filters were analyzed for total dust and the respirable fraction of the dust. Twenty-two representative male employees were evaluated. The workers served as their own controls. A questionnaire (modified British Medical Research Council questionnaire) was administered, with 3 shorter questionnaires given later. Pulmonary function tests were performed on all participants before and after their shifts. This included forced expiratory volume maneuvers requiring 3 values reproducible within 5%. A waterless high fidelity spirometer was utilized. Graphs provided the following parameters: forced expiratory volume in 1 second (FEV1)and forced vital capacity (FVC). Predicted values were derived from formulae based on the data of the VA-Army Cooperative study (1974). Cutaneous patch testing was carried out using 2 epoxy resins solutions and an acetone control on 5 employees who stated they had previously had dermatitis and 3 control employees. All 3 test solutions were pretested on male albino rabbits, and rabbit skin irritation indices were developed.

A follow-up medical survey was conducted on 14 men who were judged to be most symptomatic after exposure. Repeat pulmonary function testing occurred to determine the presence or absence of chronic residual pulmonary dysfunction.

Results and discussion

Results:
The epoxy powder containing BTDA was not toxic to workers at the concentration measured during normal operating conditions. Seven of 22 men surveyed reported persistent cough, phlegm production and shortness of breath, but all but one demonstrated normal pulmonary function tests. All employees who underwent patch testing showed negative results (although there were reports that the patch may not have been adequately attached due to the employees movement and perspiration).

Any other information on results incl. tables

Seven of the men surveyed (5 smokers and 2 non-smokers) gave a history of development of chest symptoms after exposure to epoxy powder. These included sore throat, dry throat, stuffy nose, runny nose, chest discomfort, chest tightness, shortness of breath, and cough. Their pulmonary function tests revealed no significant acute changes in FVC or FEV1 over the course of the day during which time they developed these symptoms.

Personal air sample measurements ranged from 0.89 mg/M3 to 1.53 mg/M3, the two bulk air samples for total dust ranged from 0.80 mg/M to 2.51 mg/M3. No data was available on particle size.

Applicant's summary and conclusion

Conclusions:
A health hazard evaluation study was conducted in a workplace utilizing epoxy powder containing isopropylidene diphenol epichlorhydren and BTDA. Quantitative air measurements were made, and a medical questionnaire, pulmonary function testing and dermal irritation and sensitisation testing was undertaken on 22 representative employees. The epoxy powder was found to be present at low concentrations, and was not associated with demonstrable acute or chronic pulmonary toxicity in workers at the concentration measured during normal operating conditions.