The Threshold of Toxicological Concern for prenatal developmental toxicity in rats and rabbits

Regulatory Toxicology and Pharmacology

Volumn 88, Issue , 2017, Pages 157-172

  van Ravenzwaay, B ^a   Jiang, X ^a   Luechtefeld, T ^b   Hartung, T ^b,c  

^a BASF SE   (Germany)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF KONSTANZ   (Germany)

Author keywords

Developmental toxicity; NOAEL; Rabbit; Rat; TTC

Indexed keywords

AGRICULTURAL CHEMICAL; INDUSTRIAL CHEMICAL;

ANIMAL EXPERIMENT; ARTICLE; DEVELOPMENTAL TOXICITY; FEMALE; FETUS; MATERNAL TOXICITY; NONHUMAN; ORYCTOLAGUS CUNICULUS; PRENATAL DEVELOPMENT; PRIORITY JOURNAL; RAT; THRESHOLD LIMIT VALUE; THRESHOLD OF TOXICOLOGICAL CONCERN; TOXICITY; ANIMAL; DRUG EFFECTS; FACTUAL DATABASE; FETUS DEVELOPMENT; LEPORIDAE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RISK ASSESSMENT; TOXICITY TESTING;

AGROCHEMICALS; ANIMALS; DATABASES, FACTUAL; FEMALE; FETAL DEVELOPMENT; FETUS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RABBITS; RATS; RISK ASSESSMENT; TOXICITY TESTS;

EID: 85021155279     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2017.06.008     Document Type: Article

References (47)

1. Ball, N., Cronin, M.T.D., Shen, J., Adenuga, M.D., Blackburn, K., Booth, E.D., Bouhifd, M., Donley, E., Egnash, L., Freeman, J.J., Hastings, C., Juberg, D.R., Kleensang, A., Kleinstreuer, N., Kroese, D., Lee, A.C., Luechtefeld, T., Maertens, A., Marty, S., Naciff, J.M., Palmer, J., Pamies, D., Penman, M., Richarz, A.-N., Russo, D.P., Stuard, S.B., Patlewicz, G., van Ravenzwaay, B., Wu, S., Zhu, H., Hartung, T., Toward good read-across practice (GRAP) guidance. ALTEX 33 (2016), 149–166.
2. Barlow, S.M., Kozianowski, G., Wurtzen, G., Schlatter, J., Threshold of toxicological concern for chemical substances present in the diet. Food Chem. Toxicol. 39 (2001), 893–905.
3. Basketter, D.A., Clewell, H., Kimber, I., Rossi, A., Blaauboer, B., Burrier, R., Daneshian, M., Eskes, C., Goldberg, A., Hasiwa, N., Hoffmann, S., Jaworska, J., Knudsen, T.B., Landsiedel, R., Leist, M., Locke, P., Maxwell, G., McKim, J., McVey, E.A., Ouédraogo, G., Patlewicz, G., Pelkonen, O., Roggen, E., Rovida, C., Ruhdel, I., Schwarz, M., Schepky, A., Schoeters, G., Skinner, N., Trentz, K., Turner, M., Vanparys, P., Yager, J., Zurlo, J., Hartung, T., A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing. ALTEX 29 (2012), 3–89.
4. Bernauer, U., Heinemeyer, G., Heinrich-Hirsch, B., Ulbrich, B., Gundert-Remy, U., Exposure-triggered reproductive toxicity testing under the REACH legislation: a proposal to define significant/relevant exposure. Toxicol. Lett. 176 (2008), 68–76.
5. Blackburn, K., Stickney, J.A., Carlson-Lynch, H.L., McGinnis, P.M., Chappell, L., Felter, S.P., Application of the threshold of toxicological concern approach to ingredients in personal and household care products. Regul. Toxicol. Pharmacol. 43 (2005), 249–259.
6. Bowler, M., HtmlUnit. 2002 http://sourceforge.net/p/htmlunit/mailman/message/5463073/.
7. Chodorow, K., MongoDB: the Definitive Guide. 2013, O'Reilly Media, Inc, Sebastopol, CA, 432.
8. Cramer, G.M., Ford, R.A., Hall, R.L., Estimation of toxic hazard – a decision tree approach. Food Cosmet. Toxicol. 16 (1978), 255–276.
9. De Wolf, W., Sieber-Sauer, A., Lecloux, A., Koch, A., Holt, M., Feytel, T., Comber, M., Boeije, G., Mode of action and aquatic exposure thresholds of no concern. Environ. Toxic. Chem. 24 (2005), 479–485.
10. Dolan, D.G., Nauman, B.D., Sargent, E.V., Maier, A., Dourson, M., Application of the threshold of toxicological concern concept to pharmaceutica manufacturing operations. Regul. Toxicol. Pharmacol. 43 (2005), 1–9.
11. EFSA, European Food Safety Authority. Scientific Panel on Food Additives, Flavorings, Processing Aids and Materials in Contact with Food. 2004 Opinion on Flavoring 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. Available at: www.efsa.eu.int/science/afc/catindex_en.html.
12. EFSA, European Food Safety Authority. EFSA Scientific Committee. 2011 DRAFT Scientific Opinion on Exploring options for providing preliminary advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC) Endorsed for Public Consultation 2011. Available at: http://www.efsa.europa.eu/en/consultationsclosed/call/110712a.pdf.
13. EMEA, The European Medical Control Agency. Committee for Medicinal Products for Human Use. 2003 Guideline on the limits of genotoxic impurities. London, 23 June 2003 http://eudra.org/emea.html.
14. EMEA, European Medicines Evaluation Agency. Committee for Medicinal Products for Human Use (CHMP). 2004 Guideline on the limits of genotoxic impurities. CPMP/SWP/5199/02. London, 23 June 2004 http://www.emeaeu.int/pdfs/human/swp/519902en.pdf.
15. EPA Health Effects Test Guidelines, OPPTS 870.3700: Prenatal Developmental Toxicity Study (Aug 1998).
16. Escher, S.E., Tluczkiewicz, I., Batke, M., Bitsch, A., Melber, C., Kroese, E.D., Buist, H.E., Mangelsdorf, I., Evaluation of inhalation TTC values with the data base RepDose. Regul. Toxicol. Pharmacol. 58 (2010), 259–274.
17. Food and Drug Administration, US Food and Drug Administration, Department of Health and Human Services. 1995, 174 Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles 21 CFR Parts 5, 25 170, 171.
18. Godbillon, S., ReactiveMongo. 2015, GitHub repository https://github.com/ReactiveMongo.
19. Hartung, T., Making big sense from big data in toxicology by read-across. ALTEX 33 (2016), 83–93.
20. Health Canada, Sience Approaóch Doucment, Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances. 2016 http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=326E3E17-1.
21. IPCS, International Program on Chemical Safety. 1998, World Health Organisation, WHO Food Additives Series 35, WHO, Geneva, Switzerland.
22. JECFA, Evaluation of Certain Food Additives and Contaminants. Safety Evaluation of Flavoring Agents. Forty-first Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Technical Report Series 837, 1993, World Health Organization, Geneva.
23. JECFA, Evaluation of Certain Food Additives and Contaminants. Safety evaluation of flavoring agents. WHO Technical Report Series 859 Forty-fourth Report of the Joint FAO/WHO Expert Committee on Food Additives, 1995, World Health Organization, Geneva, 2–3.
24. JECFA, Evaluation of Certain Food Additives and Contaminants. Procedure for the safety evaluation of flavoring agents. WHO Technical Report Series 884 Forty-ninth Report of the Joint FAO/WHO Expert Committee on Food Additives, 1999, World Health Organization, Geneva, 3–6.
25. JECFA, Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA 1956-2003). First through Sixty-first Meetings, 2003 http://jecfa.ilsi.org/.
26. JECFA, Joint FAO/WHO Expert Committee on Food Additives Sixty-fifth Meeting: Summary and Conclusions, June 7-16, 2005. 2005, Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO), Geneva, Switz. [JECFA/65/SC]. Available from: ftp://ftp.fao.org/es/esn/jecfa/jecfa65_summary.pdf.
27. JECFA, Evaluation of Certain Food Additives and Contaminants. Sixty-fifth Report of the Joint FAO/WHO Expert Committee on Food Additives, June 7-16, 2005., 2006, Geneva. World Health Organization (WHO), Geneva, Switz. WHO Technical Report Series, No. 934. Available from: http://whqlibdoc.who.int/trs/WHO_TRS_934.pdf.
28. Kroes, R., Renwick, A.G., Cheeseman, M., Kleiner, J., Mangelsdorf, I., Piersma, A., Schilter, B., Schlatter, J., van Schothorst, F., Vos, J.G., Wurtzen, G., Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem. Toxicol. 42 (2004), 65–83.
29. 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., Applications of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients. Food Chem. Toxicol. 45 (2007), 2533–2562.
30. Laufersweiler, M.C., Gadagbui, B., Baskerville-Abraham, I.M., Maier, A., Willis, A., Scialli, A.R., Carr, G.J., Felter, S.P., Blackburn, K., Daston, G., Correlation of chemical structure with reproductive and developmental toxicity as it relates to the use of the threshold of toxicological concern. Regul. Toxicol. Pharmacol. 62 (2012), 160–182.
31. Leist, M., Hasiwa, N., Rovida, C., Daneshian, M., Basketter, D., Kimber, I., Clewell, H., Gocht, T., Goldberg, A., Busquet, F., Rossi, A.-M., Schwarz, M., Stephens, M., Taalman, R., Knudsen, T.B., McKim, J., Harris, G., Pamies, D., Hartung, T., Consensus report on the future of animal-free systemic toxicity testing. ALTEX 31 (2014), 341–356.
32. Luechtefeld, T., Maertens, A., Russo, D.P., Rovida, C., Zhu, H., Hartung, T., Global analysis of publicly available safety data for 9,801 substances registered under REACH from 2008-2014. ALTEX 33 (2016), 95–109.
33. Luechtefeld, T., Maertens, A., Russo, D.P., Rovida, C., Zhu, H., Hartung, T., Analysis of public oral toxicity data from REACH registrations 2008-2014. ALTEX 33 (2016), 111–122.
34. Luechtefeld, T., Maertens, A., Russo, D.P., Rovida, C., Zhu, H., Hartung, T., Analysis of Draize eye irritation testing and its prediction by mining publicly available 2008-2014 REACH data. ALTEX 33 (2016), 123–134.
35. Luechtefeld, T., Maertens, A., Russo, D.P., Rovida, C., Zhu, H., Hartung, T., Analysis of publically available skin sensitization data from REACH registrations 2008-2014. ALTEX 33 (2016), 135–148.
36. 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. 56 (2010), 126–134.
37. 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., Harpur, E., Humfrey, C.D.N., Jacks, A.S., Jagota, N., Mackinnon, J., Mohan, G., Ness, D.K., ÓDonovan, M.R., Smith, M.D., Vudathala, G., Yotti, L., A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul. Toxicol. Pharmacol. 44 (2006), 198–211.
38. Munro, I.C., Safety assessment procedures for indirect food additives: an overview. Report of a Workshop. Regul. Toxicol. Pharmacol. 12 (1990), 2–12.
39. 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. 34 (1996), 829–867.
40. Munro, I.C., Kennepohl, E., Kroes, R., A procedure for the safety evaluation of flavoring substances. Food Chem. Toxicol. 37 (1999), 207–232.
41. OECD Guideline for Testing of Chemicals, Proposal for Updating Guideline 414: Prenatal Developmental Toxicity Study. 22 Jan 2001.
42. Patlewicz, G., Ball, N., Becker, R.A., Blackburn, K., Booth, E., Cronin, M., Kroese, D., Steup, D., van Ravenzwaay, B., Hartung, T., Read-across approaches - misconceptions, promises and challenges ahead. ALTEX 31 (2014), 387–396.
43. R Development Core Team, R: a Language and Environment for Statistical Computing. 2013, R Foundation for Statistical Computing, Vienna, Austria http://www.R-project.org.
44. Renwick, A.G., Toxicology databases and the concept of thresholds of toxicological concern as used by the JECFA for the safety evaluation of flavoring agents. Toxicol. Lett. 149 (2004), 223–234.
45. Tluczkiewicz, I., Buist, H.E., Martin, M.T., Mangelsdorf, I., Escher, S.E., Improvement of the Cramer classification for oral exposure using the database TTC RepDose – A strategy description. Regul. Toxicol. Pharmacol. 61 (2011), 340–350.
46. van Ravenzwaay, B., Dammann, M., Buesen, M., Schneider, S., The threshold of toxicological concern for prenatal developmental toxicity. Regul. Toxicol. Pharmacol. 59 (2011), 81–90.
47. van Ravenzwaay, B., Dammann, M., Buesen, R., Flick, B., Schneider, S., The threshold of toxicological concern for prenatal developmental toxicity in rabbits and a comparison of TTC values in rats. Regul. Toxicol. Pharmacol. 64 (2012), 1–8.