FIGURE 7.2 Metabolism of isopulegone, pulegone, and isopulegyl acetate.

Finally, the essential oil itself is evaluated in the context of the combined intake of all congeneric groups and any other related data in Step 8. Interestingly, members of the terpene alicyclic secondary alcohols, ketones, and related esters, multiple members of the monoterpene hydrocarbons, and peppermint oil itself show a common nephrotoxic effect recognized as a-2u-globulin nephropathy. The microscopic evidence of histopathology of the kidneys for male rats in the mint oil study is consistent with the presence of a-2u-globulin nephropathy. In addition, a standard immunoassay for detecting the presence of a-2u-globulin was performed on kidney sections from male and female rats in the mint oil study (Serota, 1990). Results of the assay confirmed the presence of a-2u-globulin nephropathy in male rats (Swenberg and Schoonhoven, 2002). This effect is found only in males rats and is not relevant to the human health assessment of cornmint oil. Other toxic interactions between congeneric groups are expected to be minimal given that the NOELs for the congeneric groups and those for finished mint oils are on the same order of magnitude.

Based on the above assessment and the application of the scientific judgment, cornmint oil is concluded to be "GRAS" under conditions of intended use as a flavoring substance. Given the criteria used in the evaluation, recommended specifications should include the following chemical assay:

1. Less than 95% alicyclic secondary alcohols, ketones, and related esters, typically measured as (-)-menthol.

2. Less than 2% 2-isopropylidenecyclohexanones and their metabolites, measured as (-)-pulegone.

3. Less than 10% monoterpene hydrocarbons, typically measured as limonene.

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