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Data Evaluation Record - An Acute Dermal Toxicity Study of Granola 97 in Rabbits MRID No.: 44438702
DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING
(§152-11; 870.1200)
Related Information
Information related to this page:Study Title: An Acute Dermal Toxicity Study of Granola 97 in Rabbits
Date: 1/25/98
EPA Reviewer: Sheryl K. Reilly, Ph.D.
Biopesticides and Pollution Prevention Division (7511C)MRID No.: 44438702
File Jacket Symbol: 4822-UOO
DP Barcode: D243976
Study No.: 3068.65
Study Completion Date: October 16, 1997Sponsor: S.C. Johnson & Son, Inc., Racine, WI 53403-2236
Testing Facility: Springborn Laboratories, Inc., Spencerville, OH 45887Author: 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
Species: New Zealand White Rabbits
Age: Approximately 12 weeks
Weight: Males: 2.6-2.7 kg; Females: 2.5-2.7 kg
Source: Myrtle's Rabbitry, Thompson Station, TN
Conclusion:
- Estimated LD50 > 5000 mg/k
- Tox. Category: IV
- Classification: Acceptable
Males: > 5000 mg/kg
Females: > 5000 mg/kg
Combined: > 5000 mg/kg
Procedural Deviations from Subdivision M Guideline §152-11: None
Results:
| Dosage (mg/kg) | Number of Deaths/Number Tested Males |
Number of Deaths/Number Tested Females |
Number of Deaths/Number Tested Combined |
|---|---|---|---|
5000 |
0/5 |
0/5 |
0/10 |
Observations:
In this study, 5 male and 5 female NZW rabbits were tested at 5000 mg/kg. All rats survived and gained weight. Transient dark material around the mouth was observed in one animal. Significant dermal irritation was noted at the site of test material application, which included erythema, edema, dermal lesions, eschar, necrosis, desquamation and blanching, to varying degrees in all animals tested.
Gross Necropsy:
No significant changes were observed at necropsy. Three incidences of cysts on the oviducts were observed; however, these findings are not considered to be related to the test material application, as they are "commonly found in rabbits of this strain," according to the study author.