Benigni R, Bossa C, Jeliazkova N, et al. (2008). The Benigni/Bossa rulebase for mutagenicity and carcinogenicity - a module of Toxtree. European Commission Report. EUR 23241 EN.
Application of threshold of toxicological concern concept to pharmaceutical manufacturing operations
Dolan DG, Naumann BD, Sargent EV, et al. (2005). Application of threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul Toxicol Pharmacol 43:1-9.
Food additives: Threshold of regulation of substances used in food-contact articles: Final rule
Food and Drug Administration (FDA). (1995). Food additives: threshold of regulation of substances used in food-contact articles: final rule. Fed Regist 60:36582-96.
ILSI Europe Threshold of Toxicological Concern Task Force Report
International Live Sciences Institute (ILSI). (1999). Threshold of toxicological concern for chemical substances present in the diet. ILSI Europe Threshold of Toxicological Concern Task Force Report.
WHO Technical Report Series 884. Geneva: World Health Organization
Joint FAO/WHO Expert Committee on Food Additives (JEFCA). (1999). Evaluation of certain food additives and contaminants. Procedure for the safety evaluation of flavouring agents. WHO Technical Report Series 884. Geneva: World Health Organization.
Structure-based thresholds of toxicological concern (TTC): Guidance for application to substances present at low levels in the diet
Kroes R, Renwick AG, Cheeseman M, et al. (2004). Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem Toxicol 42:65-83.
McDonald S. (2002). Science and the regulation of biological products. The Center for Biologics Evaluation and Research. Dept. of Health and Human Services. Available from: http://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/100YearsofBiologicsRegulation/UCM070313.pdf.
A rational for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
Müller L, Mauthe R, Riley C, et al. (2006). A rational for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul Toxicol Pharmacol 44:198-211.
Correlation of structural class with no-observed-effect-levels: A proposal for establishing a threshold of concern
Munro IC, Ford RA, Kennepohl E, Sprenger JG. (1996). Correlation of structural class with no-observed-effect-levels: a proposal for establishing a threshold of concern. Food Chem Toxicol 34:829-67.