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Threshold of Toxicological Concern (TTC) is a promising approach for evaluating the human health risk for systemic toxicity when there is a lack of toxicological information. The threshold for systemic toxicity is reportedly 1800, 540, and 90 μg/day for Cramer I-III chemical structures, according to Munro's structural decision tree, and 0.15 μg/day for genotoxic compounds. However, the concept of TTC has been developed for single substances; therefore, the applicability of TTC for mixtures remains unclear. To expand application of probability approach for mixtures, a validation study using the point of departures (PoDs) derived from mixtures is required. In the present study, we investigated novel TTC of botanical extracts (Botanical-TTC) for cosmetics from a meta-analysis based on the PoDs derived from repeated dose toxicity testing in botanical extracts. Accordingly, 213 PoDs were determined by repeated-dose toxicity studies and divided using a default uncertainty factor of 100 combined with the extrapolation factor of study duration to calculate the derived-no-effect-level (DNEL) and derived-minimal-effect-level (DMEL). The minimum DNEL/DMEL was 1.6-fold higher than the Cramer III TTC. In addition, because human health risk below the 1 st percentile value (663 μg/day) was considered as extremely limited, the exposure level can be proposed as Botanical-TTC.
This article was published in the following journal.
Name: Toxicology letters
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The study of medicines derived from botanical sources.
A piperidine botanical insecticide.
A botanical insecticide that is an inhibitor of mitochondrial electron transport.
A plant family of the order Cornales, subclass Rosidae, class Magnoliopsida. Some botanical classifications do not recognize this family and place the members in CORNACEAE.
A plant genus in the family MYRTACEAE, order Myrtales, subclass Rosidae. It is best known for cloves, which is the flower bud that is the source of an oil rich in EUGENOL. The botanical name has varied: Syzygium aromaticum (L.) Merr. & L. M. Perry = Eugenia caryophyllata Thunb. = Caryophyllus aromaticus L. The Eugenia-Syzygium name is discussed in Amer. J. Bot 59:423 1972.