Evaluation of inhalation TTC values with the database RepDose

Regulatory Toxicology and Pharmacology

Volumn 58, Issue 2, 2010, Pages 259-274

  Escher, S E ^a   Tluczkiewicz, I ^a   Batke, M ^a   Bitsch, A ^a   Melber, C ^a   Kroese, E D ^b   Buist, H E ^b   Mangelsdorf, I ^a  

^a FRAUNHOFER INSTITUTE FOR TOXICOLOGY AND EXPERIMENTAL MEDICINE   (Germany)

^b TNO   (Netherlands)

Author keywords

Inhalation toxicity; Risk assessment; Threshold of toxicological concern; TTC concept

Indexed keywords

COSMETIC; DOMESTIC CHEMICAL; DRINKING WATER; FLAVORING AGENT; INDUSTRIAL CHEMICAL; ORGANOPHOSPHATE;

ARTICLE; CONCENTRATION (PARAMETERS); DRUG PURITY; FOOD CONTAMINATION; GENOTOXICITY; HUMAN; INHALATION; MAXIMUM ALLOWABLE CONCENTRATION; NONHUMAN; PRIORITY JOURNAL; REFERENCE DATABASE; REFERENCE VALUE; RESPIRATORY SYSTEM; RISK ASSESSMENT; SENSITIVITY ANALYSIS; TOXICITY TESTING;

ANIMALS; CHEMICAL INDUSTRY; DATABASES AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; HAZARDOUS SUBSTANCES; HUMANS; INHALATION EXPOSURE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RISK ASSESSMENT; TOXICOLOGY;

EID: 77957353038     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.06.009     Document Type: Article

References (22)

1. Barlow S. Threshold of toxicological concern (TTC) - a tool for assessing substances of unknown toxicity present at low levels in the diet. International Life Science Institute Europe Concise Monograph Series 2005, 1-32. ILSI Europe a. i. s. b. l., Brüssel.
2. Bitsch A., Jacobi S., Melber C., Wahnschaffe U., Simetska N., Mangelsdorf I. REPDOSE: a database on repeated dose toxicity studies of commercial chemicals - a multifunctional tool. Regul. Toxicol. Pharmacol. 2006, 46:202-210.
3. Blackburn K., Stickney J.A., Carlson-Lynch H.L., McGinnis P.A., Chappell L., Felter S.P. Application of the threshold of toxicological concern approach to ingredients in personal and household care products. Regul. Toxicol. Pharmacol. 2005, 43:249-259.
4. Carthew P., Clapp C., Gutsell S. Exposure based waiving: the application of the toxicological threshold of concern (TTC) to inhalation exposure for aerosol ingredients in consumer products. Food Chem. Toxicol. 2009, 47:1287-1295.
5. Cheeseman M.A., Machuga E.J., Bailey A.B. A tiered approach to threshold of regulation. Food Chem. Toxicol. 1999, 37:387-412.
6. Cramer G.M., Ford R.A., Hall R.L. Estimation of toxic hazard - a decision tree approach. Food Cosmet. Toxicol. 1978, 16:255-276.
7. Delaney E.J. An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals. Regul. Toxicol. Pharmacol. 2007, 49:107-124.
8. ECHA, 2008, Guidance on information requirements and chemical safety assessment. Chapter R.5/R.8: Adaptation of Information Requirements/Characterisation of Dose [concentration]-response for Human Health. European Chemicals Agency.
9. Escher S., Bitsch A., Batke M., Melber C., Simetska N., Mangelsdorf I. Influence of study parameters on TTC. Toxicol. Lett. 2008, 181:61. Poster presentation.
10. Felter S., Lane R.W., Latulippe M.E., Llewellyn G.C., Olin S.S., Scimeca J.A., Trautman T.D. Refining the threshold of toxicological concern (TTC) for risk prioritization of trace chemicals in food. Food Chem. Toxicol. 2009, 47:2236-2245.
11. GHS - Globally Harmonized System of Classification and Labelling of Chemicals, 2007. Economic Commission for Europe, United Nations. p. 537.
12. Kroes R., Galli C., Munro I., Schilter B., Tran L.A., Walker R., Würtzen G. Threshold of toxicological concern for chemical substances present in the diet: a practical tool for assessing the need for toxicity testing. Food Chem. Toxicol. 2000, 38:255-312.
13. Kroes R., Renwick A., Cheesman M., Kleiner J., Mangelsdorf I., Piersma A., Schilter B., Schlatter J., van Schothorst F., Vos J.G., Wurtzen G. Structured-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem. Toxicol. 2004, 42:65-83.
14. Kroes R., Renwick A.G., Feron V., Galli C.L., Gibney M., Greim H., Guy R.H., Lhuguenot J.C., van de Sandt J.J.M. Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients. Food Chem. Toxicol. 2007, 45:2533-2562.
15. Melching-Kollmuß S., Dekant W., Kalberlah F. Application of the " threshold of toxicological concern" to derive tolerable concentrations of " non-relevant metabolites" formed from plant protection products in ground and drinking water. Regul. Toxicol. Pharmacol. 2010, 56:126-134.
16. Müller L., Mauthe R.J., Riley C.M., Andino M.M., De Antonis D., Beels C., DeGeorge J., De Knaep A.G.M., Ellison D., Fagerland J.A., Frank R., Fritschel B., Galloway S., et al. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul. Toxicol. Pharmacol. 2006, 44:198-211.
17. Munro I.C., Ford R.A., Kennepohl E., Sprenger J.G. Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food Chem. Toxicol. 1996, 34:829-867.
18. Munro I.C., Shubik P., Hall R. Principles for safety evaluation of flavouring substances. Food Chem. Toxicol. 1998, 36:529-540.
19. Munro I.C., Renwick A.G., Danielewska-Nikiel B. The threshold of toxicological concern (TTC) in risk assessment. Toxicol. Lett. 2008, 180:151-156.
20. Re T.A., Mooney D., Antignac E., Dufour E., Bark I., Srinivasan V., Nohynek G. Application of the threshold of toxicological concern approach for the safety evaluation of calendula flower (Calendula officinalis) petals and extracts used in cosmetic and personal care products. Food Chem. Toxicol. 2009, 47:1246-1254.
21. Renwick A.G. Data-derived safety factors for the evaluation of food additives and environmental contaminants. Food Addit. Contam. 1993, 10:275-305.
22. Renwick A.G. Toxicology databases and the concept of thresholds of toxicological concern as used by the JECFA for the safety evaluation of flavouring agents. Toxicol. Lett. 2004, 149:223-234.