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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
other: case studies
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: This paper reports two short summaries of distinct case studies.

Data source

Reference Type:

Materials and methods

Test guideline
no guideline followed

Test material

Results and discussion

Any other information on results incl. tables

Case one identified a 51 year old woman who habitually used a henna hair dye with the test substance. The patient presented with chronic renal failure which initially responded to prednisone. Poor compliance resulted in end stage renal failure. Despite dialysis she died from coliform bronchopneumonia.


Case two identified a previously healthy woman who used a test substance-based hair dye two years prior to admission, in renal failure. She required dialysis for life threatening hyperkalemia. Biopsies of growths on her elbow were found to be allergic vasculitis. She was treated with prednisone. She remained oliguric and three weeks after admission developed irreversible ventricular fibrillation. Post-mortem revealed recent hemorrhage of the coronary artery, and a healed myocardial infarct. The lungs were congested with multiple nodules consistent of a granulomatous inflammatory process. Both kidneys were enlarged with histological and immunological evidence of crescentic glomerulonephritis.

Applicant's summary and conclusion