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J Toxicol Pathol. 2018 Jul;31(3):155-161. doi: 10.1293/tox.2018-0019. Epub 2018 May 11.

Role of pathology peer review in interpretation of the comet assay.

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Maronpot Consulting, LLC, 1612 Medfield Road, Raleigh, North Carolina 27607, USA.
Integrated Laboratory Systems, Inc., P.O.Box 13501, Research Triangle Park, North Carolina 27709, USA.
Scientific Director, Japan Flavor and Fragrance Materials Association (JFFMA), Sankei Nihonbashi Building 6th Floor, 4-7-1 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan.
Trustee and General Manager, Global Scientific and Regulatory Affairs, San-Ei Gen F. F. I., Inc., 1-1-11 Sanwa-cho, Toyonaka, Osaka 561-8588, Japan.


When a comet assay, an increasingly popular in vivo genotoxicity test, shows a positive test result, interpretation of that response requires ruling out any confounding tissue site toxicity. Since the comet assay typically uses only two or three daily doses of test agent, precursor tissue changes indicative of toxicity may be easily overlooked. Using case examples for two flavoring agents, perillaldehyde and 4,5-epoxydec-2(trans)-enal, we highlight the role of pathology peer review in verifying precursor tissue changes indicative of tissue site toxicity, thereby increasing confidence in final interpretation of comet assay results. Given global deliberation regarding safety assessment of compounds entering the marketplace, we recommend consideration of pathology peer review for equivocal and positive comet assays so that interpretations are universally consistent.


4,5-epoxydec-2(trans)-enal; comet assay; global harmonization; pathology peer review; perillaldehyde

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