Test Objective:
To determine the degree of toxicity that SyDERMA® may produce when administered orally.

Test Procedure:
This test procedure is described by the Federal Hazardous Substances Act, 16 CFR, Section 1500.3 (c).(2).(i).

Interpretation of Assay:
A single oral dose (5 grams per kilogram of body weight) was given and all test subjects were observed immediately after dosing, 4 hours after dosing and then daily for 14 days thereafter. All observations were recorded and included the following: behavioral abnormalities; gross necropsy; body weight changes; mortality; any other toxicological effects.

Test Results:
SyDERMA®, when administered as supplied to the test subjects at a single oral dosage level of 5 grams per kilogram of body weight, did not produce any compound related mortality; therefore, SyDERMA® is not considered to be toxic according to definitions listed in 16 CFR 1500.3 (c).(2).(i).

Observations:

ACUTE ORAL TOXICITY

Body Weight (in Grams)

Test Subject Sex Initial Weight Final Weight Change Test Subject #1 Female 234 278 +44 Test Subject #2 Female 262 299 +37 Test Subject #3 Female 206 245 +39 Test Subject #4 Female 229 287 +58 Test Subject #5 Female 245 308 +63 Test Subject #6 Male 253 410 +157 Test Subject #7 Male 255 417 +162 Test Subject #8 Male 250 364 +114 Test Subject #9 Male 257 381 +124 Test Subject #10 Male 254 410 +156

Dose Number

Gm/kg Fed Fatalitites 5 grams/kilogram 10 0

Necropsy

No gross abnormalities