The Concentration of No Toxicological Concern (CoNTC): A Risk Assessment Screening Tool for Air Toxics

REFERENCES

• Barlow, S. 2005. Threshold of toxicological concern (TTC). A tool for assessing substances of unknown toxicity present at low levels in the diet. International Life Sciences Institute. http://europe.ilsi.org/file/CM-ThresholdToxicologicalConcern.pdf
   Google Scholar
• Blackburn , K. , Stickney , J. A. , Carlson-Lynch , H. L. , McGinnis , P. M. , Chappell , L. and Felter , S. P. 2005 . Application of the threshold of toxicological concern approach to ingredients in personal and household care products . Regul. Pharmacol. Toxicol. , 43 : 249 – 259 .
   PubMed Web of Science ®Google Scholar
• Caldwell , J. C. , Woodruff , T. J , Morello-Frosch , R. and Axelrad , D. A. 1998 . Application of health information to hazardous air pollutants modelled in EPA's cumulative exposure report . Toxicol. Ind. Health , 14 : 429 – 454 .
   PubMed Web of Science ®Google Scholar
• CFR . 2001 . United States Code of Federal Regulations 170.39 , 17 – 20 . Washington, DC : U.S. Government Printing Office . Threshold of regulation for substances used in food-contact articles. 21 CFR 170.39
   Google Scholar
• Cramer , G. M. , Ford , R. A. and Hall , R. L. 1978 . Estimation of toxic hazard: A decision tree approach . Food Cosmet. Toxicol. , 16 : 255 – 276 .
   PubMedGoogle Scholar
• Dolan , D. G. , Naumann , B. D. , Sargent , E. V. , Maier , A. and Doursen , M. 2005 . Application of the threshold of toxicological concern concept top pharmaceutical manufacturing operations . Regul. Pharmacol. Toxicol. , 43 : 1 – 9 .
   PubMed Web of Science ®Google Scholar
• European Commission. 1996. Opinion of the Scientific Committee on Food on the scientific basis of the concept of threshold of regulation in relation to food contact materials (expressed on 8 March 1996), Reports of the Scientific Committee on Food, 39th Series, catalogue no: GT 07 97644-EN, Office for Official Publications of the European Community, L-2985 Luxembourg.
   Google Scholar
• European Commission. 2003. European Commission Health & Consumer Protection Directorate–General Directorate D–Food Safety: Production and Distribution Chain D3–Chemical and Physical Risks; Surveillance Food Contact Materials Practical Guide. Updated 15 April 2003.
   Google Scholar
• European Commission, Joint Research Centre. 2005. REACH and the need for Intelligent Testing Strategies Institute for Health and Consumer Protection, European Commission, Joint Research Centre, 21020 Ispra (VA), Italy. http://www.jrc.cec.eu.int/download/20051107its.pdf
   Google Scholar
• European Food Safety Authority. 2004. Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food. Opinion on Flavouring Group FGE.03 Acetals of branched- and straight-chain aliphatic saturated primary alcohols and branched- and straight-chain saturated aldehydes, and an orthoester of formic acid, from chemical groups 1 and 2. Opinion expressed on 7 October 2004. European Food Safety Authority. www.efsa.eu.int/science/afc/catindex_en.html (www.efsa.eu.int/science/afc/catindex_sen.html)
   Google Scholar
• European Medicines Agency. 2004. Committee for Medicinal Products for Human Use (CHMP). Guideline on the limits of genotoxic impurities. European Medicines Agency. CPMP/SWP/5199/02. London, 23 June 2004. www.emea.eu.int/pdfs/human/swp/519902en.pdf
   Google Scholar
• Food and Drug Administration. 1982. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, Redbook, U.S. Food and Drug Administration, Bureau of Foods, Washington, DC.
   Google Scholar
• Food and Drug Administration . 1993 . U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Redbook II . Fed. Reg. , 58 : 16536
   Google Scholar
• Food and Drug Administration . 1995 . Food additives; threshold of regulation for substances used in food-contact articles. Final rule . Fed. Reg. , 60 ( 136 ) : 36582 – 36594 .
   Google Scholar
• Federal Register . 1993 . Food additives: Threshold of regulation for substances used in food-contact articles . Fed. Reg. , 58 ( 195 ) : 52719 – 52727 .
   Google Scholar
• Frawley , J. P. 1967 . Scientific evidence and common sense as a basis for food-packaging regulations . Food. Cosmet. Toxicol. , 5 : 293 – 308 .
   PubMedGoogle Scholar
• Joint FAO/WHO Expert Committee on Food Additives. 1993. Evaluation of Certain Food additives and Contaminants. Safety evaluation of flavouring agents. Forty-first Report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series 837. World Health Organization, Geneva.
   Google Scholar
• Joint FAO/WHO Expert Committee on Food Additives. 1995. Evaluation of certain food additives and contaminants. Safety evaluation of flavouring agents. Forty-fourth Report of the Joint FAO/WHO Expert Committee on Food Additives, pp. 2–3. WHO Technical Report Series 859. World Health Organization, Geneva.
   Google Scholar
• Joint FAO/WHO Expert Committee on Food Additives. 1999. Evaluation of certain food additives and contaminants. Procedure for the safety evaluation of flavouring agents. Forty-ninth Report of the Joint FAO/WHO Expert Committee on Food Additives, pp. 3–6. WHO Technical Report Series 884. World Health Organization, Geneva.
   Google Scholar
• Kroes , R. , Galli , C. , Munro , I. , Schilter , B. , Tran , L.A. , Walker , R. and Wurtzen , G. 2000 . Threshold of toxicological concern for chemical substances in the diet: A practical tool for assessing the need for toxicity testing . Food. Chem. Toxicol. , 38 : 255 – 312 .
   PubMed Web of Science ®Google Scholar
• Kroes , R. and Kozianowski , G. 2002 . Threshold of toxicological concern (TTC) in food safety assessment . Toxicol. Lett. , 127 : 43 – 46 .
   PubMed Web of Science ®Google Scholar
• Kroes , R. , Renwick , A. G. , Cheesman , M. , Kleiner , J. , Mangelsdorf , I. , Piersma , A. , Schilter , B. , Schlatter , J. , van Schothorst , F. , Vos , J. G. and Wurtzen , G. 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 .
   PubMed Web of Science ®Google Scholar
• Kroes , R. , Kleiner , J. and Renwick , A.G. 2005 . The threshold of toxicological concern concept in risk assessment . Toxicol. Sci. , 86 : 226 – 230 .
   PubMed Web of Science ®Google Scholar
• Langley , A. J. and Sabordo , A. 1996 . “ Exposure factors in risk assessment ” . In The health risk assessment and management of contaminated sites , Contaminated Sites Monograph Series No. 5 Edited by: Langley , A. , Markey , B. and Hill , H. 137 – 190 . South Australian Health Commission, South Australia . Proceedings of the Third National Workshop,
   Google Scholar
• Munro , I. C. 1990 . Safety assessment procedures for indirect food additives: An overview . Regul. Toxicol. Pharmacol. , 12 : 2 – 12 .
   PubMed Web of Science ®Google Scholar
• Munro , I. C. , Ford , R. A. , Kennepohl , E. and Sprenger , J. G. 1996 . Correlation of structural class with no-observed-effect levels: A proposal for establishing a threshold of concern . Food Chem. Toxicol. , 34 : 829 – 867 .
   PubMed Web of Science ®Google Scholar
• Munro , I. C. , Kennepohl , E. and Kroes , R. 1999 . A procedure for the safety evaluation of flavouring substances . Food Chem. Toxicol. , 37 : 207 – 232 .
   PubMed Web of Science ®Google Scholar
• Munro , I. C. , Hlywka , J. J. and Kennepohl , E. M. 2002 . Risk assessment of packaging materials . Food Addit. Contam. , 19 : 3 – 12 .
   PubMed Web of Science ®Google Scholar
• RAIS . 2004 . Risk Assessment Information System , Washington, DC : U.S. Department of Energy .
   Google Scholar
• World Health Organization . . Toxicological Evaluations of Certain Food Additives and Contaminates in Food . Prepared by the 44th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), WHO Food Additive Series 35 . pp. 423 – 450 .
   Google Scholar
• Wilson , R. M. , Sigal , E. A. , Bacigalupo , C. M. , Willes , R. F. and Munro , I. C. 2000 . Derivation of risk management criteria for chemicals of unknown potency at contaminated sites . Hum. Ecol. Risk Assess. , 6 : 131 – 139 .
   Web of Science ®Google Scholar