Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A case study in humans was reported. Composite Group C-2, under the test conditions, was capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a sensitizer in 2/200 subjects. 

Additional information

A case study in humans was reported. Composite Group C-2, under the test conditions, was capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a sensitizer in 2/200 subjects. Setacyl Yellow P-FL, 130-142-730 and Setacyl Scarlet. P-GBL, 130-295-770, when tested individually, were each capable of eliciting skin changes consistent with the criteria deemed characteristic of a sensitizer in one of the two subjects noted above. The other two components of this group, when tested individually, were not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent or sensitizer in either of the two subjects noted above. It is the opinion of the investigator that Setacyl Yellow P-FL 130-142-730 or Setacyl Scarlet P-GBL 130-295-770 would constitute a hazard if they should remain in prolonged intimate contact with the skin. Setacyl Yellow P-4RL 130-140-700 or Setacyl Turquoise Blue G Supra 130-347-720 or a combination of the two may be considered innocuous under the normal use of such material as long as conditions of use do not exceed those under which it was evaluated herein