Test Objective:
To ascertain the potential for dermal irritation of SyDERMA®.

Test Procedure:
This test procedure is described by the Federal Hazardous Substances Act, 16 CFR, Section 1500.41. The Draize Score method was used for interpretation.

Interpretation of Assay:
Following the seventy-two hour reading, the scores for twenty-four and seventytwo hour gradings were averaged to determine the primary irritation index. A Primary Irritation Score of 5.0 or more (using the Draize Score method) indicates a primary dermal irritant.

Test Results:
SyDERMA®, when dosed as supplied in accordance with the above procedure, produced very slight to well-defined erythema and very slight to well-defined edema. Using the Draize Score method, the Primary Irritation Score was 1.83. SyDERMA® has the potential for mild irritation under occluded test conditions, however, SyDERMA® would not be classified as a primary skin irritant as defined by the Federal Hazardous Substances Act, 16 CFR, Section 1500.3 (c).(4).