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Data Evaluation Record - Primary Skin Irritation Study of Granola 97 in Rabbits MRID No.: 44438704
DATA REVIEW FOR PRIMARY DERMAL IRRITATION TESTING
(§152-14, 870.2500)
Related Information
Information related to this page:Study Title: A Primary Skin 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.: 44438704
File Jacket Symbol: 4822-UOO
DP Barcode: D243976
Study No.: 3068.67
Study Completion Date: October 16, 1997
Sponsor: S.C. Johnson & Son, Inc., Racine, WI 53403-2236
Testing Facility: Springborn Laboratories, Inc., Spencerville, OH 45887Quality Assurance (40 CFR '160.12): Included
Test Material: Granola 97 (99% p-Menthane-3,8-diol); Lot 703001; clear viscous liquid
Dosage: 0.5 mL
b New Zealand White Rabbits
Age: Approximately 11 weeks
Weight: Males: 2.2-2.3 kg; Females: 2.4 kg
Source: Myrtle's Rabbitry, Thompson Station, TN
Conclusion:
- Toxicity Category: IV (Mild or Slight irritant)
- Classification: Acceptable
Procedural Deviations from Subdivision M Guideline §152-14: None
Results:
Six NZW rabbits (3 per sex) were treated dermally with 0.5 mL of the undiluted test substance, and the test site was covered with a semi-occlusive dressing for 4 hours. After the exposure period, the patches were removed and residual test material was wiped from the exposed skin with gauze moistened with distilled water. One hour after patch removal, very slight erythema and well-defined erythema were noted on 4/6 and 2/6 rabbits, respectively. The erythema cleared by 72 hours on 4/6 rabbits; the remaining 2 animals exhibited barely perceptible erythema at this time point. By day 7, no traces of irritation was observed in these animals. The PDIS = 1.1 (Slight irritant).