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Data Evaluation Record - Dermal Sensitization Study of Granola 97 in Guinea Pigs, Modified Buehler Design MRID No.: 44438705
DATA REVIEW FOR DERMAL SENSITIZATION STUDY
('152-15; 870.2600)
Related Information
Information related to this page:Study Title: A Dermal Sensitization Study of Granola 97 in Guinea Pigs, Modified Buehler Design
Date: 1/25/98
EPA Reviewer: Sheryl K. Reilly, Ph.D.
Biopesticides and Pollution Prevention Division (7511P)MRID No.: 44438705
File Jacket Symbol: 4822-UOO
DP Barcode: D243976
Study No.: 3068.68
Study Completion Date: October 16, 1997
Sponsor: 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
Positive Control Material: 1-Chloro-2,4-dinitrobenzene (DNCB)
Species: Hartley Albino Guinea pigs
Age: Approximately 7 weeks
Weight: Males: 383-499 g; Females: 356-452 g
Source: Harlan Sprague Dawley, Inc., Haslett, MI
Method: Modified Buehler Method
Conclusion:
- There is no indication that this product is a dermal sensitizer in guinea pigs.
- Classification: Acceptable
Procedural Deviations from ยง152-15: None
Procedure:
Granola 97 was evaluated for dermal sensitization potential using a modified Buehler method. For the induction phase, 0.3 mL of the undiluted test material was applied to the shaved backs of 10 male and 10 female Hartley-derived albino guinea pigs under occlusion for 6 hours once each week for 3 weeks. The animals were left untreated for 2 weeks before challenge. The animals were challenged with 0.3 mL of the undiluted test material under occlusion at naive sites for 6 hours. A naive control group consisting of 5 male and 5 female guinea pigs was treated with 0.3 mL of the undiluted test material at challenge only. Reactions were scored at 24 and 48 hours post exposure.
Results:
The test animals demonstrated little (slight, patchy) or no erythema after each induction and challenge dose. The naive control animals also exhibited little or no erythema after the challenge dose. The results of this test were compared to historical positive controls, in which 10 animals/sex were treated with DNCB as a contact sensitizer (all animals exhibited slight-to-moderate, confluent erythema following challenge) within 6 months of the present study. The test substance did not cause contact sensitization under the conditions of this study.