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Administrative data

Description of key information

Contact sensitization was absent in human volunteers whose skin were challenged with the test substance after a 3 week induction period. 0 out of 59 volunteers had positive responses.

Additional information

Sensitization

The ability to induce contact dermal hypersensitivity was studied in human volunteers using a human patch test. In the induction phase, 59 test subjects were treated with 0.3% of the test substance in dimethylphthalate under an occlusive dressing. Induction treatments, 15 in number were performed for 24 hours each on alternate days for an induction period of 3 weeks. Challenge exposures, performed 14 days after the last induction with 0.3% of the test substance in dimetylphthalate lasted for 24 hours under occlusive conditions. Challenged sites were examined immediately as well as 24 and 48 hours after removal of test patches.

In the human patch test, none of the 59 volunteers elicited skin responses suggestive of hypsersensitization (Ciba Geigy Ltd. 1969).

Occupational Exposure

The atmospheric concentration of the test substance measured at a production site in Japan ranged from <0.0058 mg/m³ to 0.21 mg/m³. The highest concentration was associated with removal of the product from the centrifuge, with the concentration around the workers mouth reaching 0.21 mg/m³. Sampling were collected near to the mouth and where possible, at waist level (JISHA 2007)