Test Objective:
To ascertain the potential for eye irritation of SyDERMA®.
Test Procedure:
This test procedure is described by the Federal Hazardous Substances Act,
16 CFR, Section 1500.42.
Interpretation of Assay:
This test is interpreted as:
Positive: If four or more test subjects exhibit
a positive response on the cornea, iris or conjunctiva.
Negative: If one or less test subjects exhibit
a positive response on the cornea, iris or conjunctiva.
Inconclusive: If two or three test subjects
exhibit a positive response on the cornea, iris or conjunctiva.
See Grades For Ocular Lesions section
which follows for definition of positive responses.
Test Results:
SyDERMA®,when tested as supplied in accordance with the above
procedure, produced minimal conjunctival irritation in five of six test
subjects. There were no positive responses. All signs of irritation cleared
by day 4 of the study. Therefore, SyDERMA® would not be considered
a primary eye irritant as defined by the Federal Hazardous Substances
Act, 16 CFR, Section 1500.3 (c).(4).
| Observations: |
| PRIMARY
SKIN IRRITATION SCORES |
| Day |
Day |
| Test Subject #1 |
1 |
2 |
3 |
4 |
|
Test Subject #2 |
1 |
2 |
3 |
4 |
| Cornea |
|
|
|
|
|
Cornea |
|
|
|
|
| Opacity |
0 |
0 |
0 |
0 |
|
Opacity |
0 |
0 |
0 |
0 |
| Area Involved |
0 |
0 |
0 |
0 |
|
Area Involved |
0 |
0 |
0 |
0 |
| Total Score = AxBx5 |
0 |
0 |
0 |
0 |
|
Total Score = AxBx5 |
0 |
0 |
0 |
0 |
| Iris |
|
|
|
|
|
Iris |
|
|
|
|
| Values |
0 |
0 |
0 |
0 |
|
Values |
0 |
0 |
0 |
0 |
| Total Score = Ax5 |
0 |
0 |
0 |
0 |
|
Total Score = Ax5 |
0 |
0 |
0 |
0 |
| Conjunctivae |
|
|
|
|
|
Conjunctivae |
|
|
|
|
| Redness |
1 |
0 |
0 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
| Chemosis |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
| Discharge |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
| Total Score = (A+B+C)x2 |
2 |
0 |
0 |
0 |
|
Total Score = (A+B+C)x2 |
2 |
0 |
0 |
0 |
| Total Irritation Score |
2 |
0 |
0 |
0 |
|
Total Irritation Score |
2 |
0 |
0 |
0 |
|
| |
| Day |
Day |
| Test Subject #3 |
1 |
2 |
3 |
4 |
|
Test Subject #4 |
1 |
2 |
3 |
4 |
| Cornea |
|
|
|
|
|
Cornea |
|
|
|
|
| Opacity |
0 |
0 |
0 |
0 |
|
Opacity |
0 |
0 |
0 |
0 |
| Area Involved |
0 |
0 |
0 |
0 |
|
Area Involved |
0 |
0 |
0 |
0 |
| Total Score = AxBx5 |
0 |
0 |
0 |
0 |
|
Total Score = AxBx5 |
0 |
0 |
0 |
0 |
| Iris |
|
|
|
|
|
Iris |
|
|
|
|
| Values |
0 |
0 |
0 |
0 |
|
Values |
0 |
0 |
0 |
0 |
| Total Score = Ax5 |
0 |
0 |
0 |
0 |
|
Total Score = Ax5 |
0 |
0 |
0 |
0 |
| Conjunctivae |
|
|
|
|
|
Conjunctivae |
|
|
|
|
| Redness |
1 |
1 |
0 |
0 |
|
Redness |
0 |
0 |
0 |
0 |
| Chemosis |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
| Discharge |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
| Total Score = (A+B+C)x2 |
2 |
2 |
0 |
0 |
|
Total Score = (A+B+C)x2 |
0 |
0 |
0 |
0 |
| Total Irritation Score |
2 |
2 |
0 |
0 |
|
Total Irritation Score |
0 |
0 |
0 |
0 |
|
| |
| Day |
Day |
| Test Subject #5 |
1 |
2 |
3 |
4 |
|
Test Subject #6 |
1 |
2 |
3 |
4 |
| Cornea |
|
|
|
|
|
Cornea |
|
|
|
|
| Opacity |
0 |
0 |
0 |
0 |
|
Opacity |
0 |
0 |
0 |
0 |
| Area Involved |
0 |
0 |
0 |
0 |
|
Area Involved |
0 |
0 |
0 |
0 |
| Total Score = AxBx5 |
0 |
0 |
0 |
0 |
|
Total Score = AxBx5 |
0 |
0 |
0 |
0 |
| Iris |
|
|
|
|
|
Iris |
|
|
|
|
| Values |
0 |
0 |
0 |
0 |
|
Values |
0 |
0 |
0 |
0 |
| Total Score = Ax5 |
0 |
0 |
0 |
0 |
|
Total Score = Ax5 |
0 |
0 |
0 |
0 |
| Conjunctivae |
|
|
|
|
|
Conjunctivae |
|
|
|
|
| Redness |
1 |
1 |
1 |
0 |
|
Redness |
1 |
0 |
0 |
0 |
| Chemosis |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
| Discharge |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
| Total Score = (A+B+C)x2 |
4 |
2 |
2 |
0 |
|
Total Score = (A+B+C)x2 |
2 |
0 |
0 |
0 |
| Total Irritation Score |
4 |
2 |
2 |
0 |
|
Total Irritation Score |
2 |
0 |
0 |
0 |
|
| AVERAGE IRRITATION SCORES |
| Day 1 |
Day2 |
Day3 |
Day4 |
| 2.0 |
1.0 |
0.3 |
0.0 |
|
|
