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Data Evaluation Record - Primary Eye Irritation Study of Granola 97 in Rabbits MRID No.: 44438703
DATA REVIEW FOR PRIMARY EYE IRRITATION TESTING
(§152-13, 870.2400)
Related Information
Information related to this page:Study Title: A Primary Eye Irritation Study of Granola 97 in Rabbits
Date: 1/25/98
EPA Reviewer: Sheryl K. Reilly, Ph.D.
Biopesticides and Pollution Prevention Division (7511P)MRID No.: 44438703
File Jacket Symbol: 4822-UOO
DP Barcode: D243976
Study No.: 3068.66
Study Completion Date: October 16, 1997Sponsor: S.C. Johnson & Son, Inc., Racine, WI 53403-2236
Testing Facility: Springborn Laboratories, Inc., Spencerville, OH 45887
Author: Bonnette, K. L.Quality Assurance (40 CFR §160.12): Included
Test Material: Granola 97 (99% p-Menthane-3,8-diol); Lot 703001; clear viscous liquid
Dosage: 0.1 mL
Species: New Zealand White Rabbits
Age: Males: Approximately 12 weeks; Females: Approximately 11-12 weeks
Weight: Males: 2.5-2.7 kg; Females: 2.5-2.7 kg
Source: Myrtle's Rabbitry, Thompson Station, TN
Conclusion:
- Toxicity Category: I (Corrosive)
- Classification: Acceptable
Procedural Deviations from Subdivision M Guideline '152-13: None
| Observations | Number "positive"/number tested | ||||||||
|---|---|---|---|---|---|---|---|---|---|
Hours |
Days |
||||||||
1 |
24 |
48 |
72 |
7 |
10 |
14 |
21 |
28 |
|
Unwashed Eyes |
|||||||||
| Corneal Opacity | 6/6 |
6/6 |
6/6 |
6/6 |
4/6 |
1/6 |
1/6 |
1/6 |
1/6 |
| Iritis | 6/6 |
6/6 |
6/6 |
6/6 |
2/6 |
1/6 |
1/6 |
1/6 |
1/6 |
| Conjunctivae: | |||||||||
| Redness | 4/6 |
6/6 |
5/6 |
3/6 |
2/6 |
1/6 |
1/6 |
0/6 |
0/6 |
| Chemosis | 6/6 |
1/6 |
1/6 |
1/6 |
1/6 |
1/6 |
1/6 |
0/6 |
0/6 |
| Discharge | 6/6 |
1/6 |
0/6 |
0/6 |
1/6 |
0/6 |
1/6 |
0/6 |
0/6 |
| Observations | Number "positive"/number tested | ||||||||
|---|---|---|---|---|---|---|---|---|---|
Hours |
Days |
||||||||
1 |
24 |
48 |
72 |
7 |
10 |
14 |
21 |
28 |
|
Unwashed Eyes |
|||||||||
| Corneal Opacity | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 | 0/3 | 0/3 | ||
| Iritis | 3/3 | 3/3 | 3/3 | 2/3 | 0/3 | 0/3 | 0/3 | ||
| Conjunctivae: | |||||||||
| Redness | 3/3 | 3/3 | 3/3 | 3/3 | 3/3 | 2/3 | 0/3 | ||
| Chemosis | 3/3 | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 | 0/3 | ||
| Discharge | 3/3 | 3/3 | 0/3 | 2/3 | 0/3 | 0/3 | 0/3 | ||
* Approximately 30 seconds after instillation of the test material, the treated eyes of 3 rabbits were washed with physiological saline.
Summary:
Nine male NZW rabbits (5 males, 4 females) were treated with 0.1 ml of Granola 97. The treated eyes of 3 (1 male, 2 females) of the animals were rinsed with physiological saline approximately 30 seconds after instillation of the test material. All rabbits exhibited corneal opacity, iritis, and conjunctival irritation 1 hour after test material instillation, which persisted through 72 hours. In the group with unwashed eyes, corneal opacity persisted in 4 rabbits through day 7, and in 1 rabbit until the study was terminated at 28 days post instillation. In the rabbits with the washed eyes, corneal opacity and iritis was cleared by day 7. Conjunctival redness above normal level was observed in 2 animals until day 10. The persistence of significant corneal damage in the unwashed group for 28 days places the test substance in toxicity category I (corrosive) for eye irritation. The product label should clearly emphasize the hazard and first aid treatment for accidental eye exposure.