Registration Dossier

Administrative data

Description of key information

A repeat insult patch test of standard methodology and to GCP was cnducted in a small panel of 55 volunteers (including males and females betwen the ages of 16 and 78 years).  A total of 9 induction patches were applied to the same area (3 per week) followed by a challenge patch appled to a different area 14 days after the final induction patch. The skin area was assessed in accordance with defined criteria after the removal of each patch.

Additional information

Observations of the skin beneath the applied patches at 24 and 72 hours post application of the challenge patch revealed observations which were considered to be within normal limits throughout the test interval. Under the conditions of this study, Decan-1,2-diol (AM1 -0049) did not indicate a potential for dermal irritation or allergic contact sensitisation.