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Sensitization data (humans)

A human sensitisation study was conducted using 96 workers employed at three facilities that manufacture or use TMXDI to evaluate the clinical (questionnaire) and immunological effects (serum antibody). The study population was divided into three groups based upon relative exposure (31 workers at <0.0004 ppm and 65 workers at < 0.0004 to 0.0102 ppm) and duration of exposure was up to 3 years. IgE and IgG against TMXDI conjugated to HSA (TMXDI-HSA) were determined by ELISA. There were no workers with immunologically induced disease due to TMXDI nor were there any workers whose questionnaires suggested new onset of asthma. Approximately 48% of workers experienced some irritant symptoms, mostly upper respiratory or ocular. Very low level IgG against TMXDI-HSA was present in 8% of workers, all of whom were in the highest exposure category. No immunologic respiratory disease has been identified in this worker population. Further, in cases of peak exposure (start-up phase), none developed evidence of immunologically mediated respiratory disease due to TMXDI isocyanate and a small proportion developed low level antibody against TMXDI-HSA. Hence, under the conditions of the study, apart from upper respiratory or ocular irritant symptoms, there was low incidence of positive serology and no clinical hypersensitivity in worker population on exposure to m-TMXDI (Grammer, 1993).