Proper knowledge on toxicokinetics improves human hazard testing and subsequent health risk characterisation. A case study approach

Regulatory Toxicology and Pharmacology

Volumn 67, Issue 3, 2013, Pages 325-334

  Bessems, Jos G M ^a,b   Geraets, Liesbeth ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^b JOINT RESEARCH CENTRE   (Italy)

Author keywords

Absorption; ADME; AUC; Bioavailability; Risk assessment; Risk characterisation; Route to route extrapolation; Species selection; Toxicokinetics

Indexed keywords

2,4 DICHLOROPHENOXYACETIC ACID; AGRICULTURAL CHEMICAL; BETA CAROTENE; BIOCIDE; BIS(BUTYLBENZOATE) DIAMINOTRIAZINE AMINOPROPYLTRISILOXANE; CAMPHOR BENZALKONIUM METHOSULPHATE; COSMETIC; FOOD ADDITIVE; PHENYLENEDIAMINE; QUATERNARY AMMONIUM DERIVATIVE; SILOXANE; UNCLASSIFIED DRUG;

ABSORPTION; AREA UNDER THE CURVE; ARTICLE; BLOOD LEVEL; CASE STUDY; CHEMICAL SAFETY; EUROPEAN UNION; EXCRETION; EXPERIMENTAL ANIMAL; HEALTH HAZARD; HUMAN; LAW; METABOLISM; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING; TOXICOKINETICS;

ANIMALIA;

ABSORPTION; ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION; ADME; AREA UNDER THE BLOOD/PLASMA CONCENTRATION TIME CURVE; AUC; BENCHMARK DOSE LOWER LIMIT; BIOAVAILABILITY; BLOOD/PLASMA CONCENTRATION-TIME CURVE; BMDL; C,T-CURVE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; NOAEL; RISK ASSESSMENT; RISK CHARACTERISATION; ROUTE-TO-ROUTE EXTRAPOLATION; SPECIES SELECTION; TK; TOXICOKINETICS;

ANIMALS; CONSUMER PRODUCT SAFETY; EUROPEAN UNION; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HAZARDOUS SUBSTANCES; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; NONTHERAPEUTIC HUMAN EXPERIMENTATION; RISK ASSESSMENT; SPECIES SPECIFICITY; TOXICITY TESTS;

EID: 84887627279     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2013.08.010     Document Type: Article

References (35)

1. ANS EFSA panel on food additives and nutrient sources added to food (ANS). Scientific opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive. EFSA J. 2012, 10(3):2593.
2. Barton H.A., Pastoor T.P., Baetcke K., Chambers J.E., Diliberto J., Doerrer N.G., Driver J.H., Hastings C.E., Iyengar S., Krieger R., Stahl B., Timchalk C. The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments. Crit. Rev. Toxicol. 2006, 36:9-35.
3. Buist, H.E., Bessems, J.G.M., De Heer, C., 2003. Dermal absorption data in risk assessment for operators - some pitfalls. TNO report V4801, 26th August 2003.
4. Buist H.E., Schaafsma G., Van de Sandt J.J.M. Relative absorption and dermal loading of chemical substances: consequences for risk assessment. Regul. Toxicol. Pharmacol. 2009, 54(2009):221-228.
5. Creton S., Saghir S.A., Bartels M.J., Billington R., Bus J.S., Davies W., Dent M.P., Hawksworth G.M., Parry S., Travis K.Z. Use of toxicokinetics to support chemical evaluation: Informing high dose selection and study interpretation. Regul. Toxicol. Pharmacol. 2012, 62:241-247.
6. De Raat W.K., Stevenson H., Hakkert B.C., Van Hemmen J.J. Toxicological risk assessment of worker exposure to pesticides: some general principles. Regul. Toxicol. Pharmacol. 1997, 25(3):204-210.
7. Dixit R., Ward P. Use of classical pharmacokinetic evaluations in drug development and safety assessment (Chapter 5). Toxicokinetics and Risk Assessment 2007, Informa Healthcare, New York. J.C. Lipscomb, E.V. Ohanian (Eds.).
8. EC Regulation (EC) No. 1107/2009 of the European parliament and of the council of 21 October 2009 concerning the placing of plant protection products on the market and repealing council directives 79/117/EEC and 91/414/EEC. Official J. Eur. Union 2009, L309:1-50.
9. ICH, 1995. CPMP/ICH/384/95. ICH Topic S 3 A. Toxicokinetics: a guidance for assessing systemic exposure in toxicology studies. Note for guidance on toxicokinetics: a guidance for assessing systemic exposure in toxicology studies. ICH Harmonised Tripartite Guideline. June 1995. EMEA, London.
10. ICH, 2009. CPMP/ICH/286/95. ICH Topic M 3 (R2). Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. Step 4. Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (cpmp/ich/286/95). June 2009. EMEA, London.
11. OECD, 2004a. OECD Test Guideline No. 427 'Skin absorption: in vivo method'.
12. OECD, 2004b. OECD Test Guideline No. 428 'Skin absorption: in vitro method'.
13. OECD, 2008. OECD Series on Testing and Assessment. No. 97. Detailed Review Paper on the Use of Metabolising Systems for In vitro Testing of Endocrine Disruptors.
14. OECD, 2010. OECD Test Guideline No. 417 'Toxicokinetics'.
15. OECD, 2011a. OECD Test Guideline No. 443 'Extended One-Generation Reproductive Toxicity Study'. Adopted 28 July 2011.
16. OECD, 2011b. OECD Series on Testing and Assessment - Guidance Document 117 On the Current Implementation of Internal Triggers in Test Guideline 443 for an Extended One Generation Reproductive Toxicity Study, in the United States and Canada.
17. Ploemen J.P., Kramer H., Krajnc E.I., Martin I. Use of toxicokinetic data in preclinical safety assessment: a toxicologic pathologist perspective. Toxicol. Pathol. 2007, 35:834-837.
18. Rennen M.A.J., Bouwman T., Wilschut A., Bessems J.G.M., De Heer C. Oral-to-inhalation route extrapolation in occupational health risk assessment: a critical assessment. Regul. Toxicol. Pharmacol. 2004, 39(1):5-11.
19. Rowland M. Clinical trials and translational medicine commentaries. Microdosing: a critical assessment of human data. J. Pharm. Sci. 2012, 101(11):4067-4074.
20. Saghir S.A., Bartels M.J., Rick D.L., McCoy A.T., Rasoulpour R.J., Ellis-Hutchings R.G., Marty M.S., Terry C., Bailey J.P., Billington R., Bus J.S. Assessment of diurnal systemic dose of agrochemicals in regulatory toxicity testing - An integrated approach without additional animal use. Regul. Toxicol. Pharmacol. 2012, 63:321-332.
21. Saghir S.A., Mendrala A.L., Bartels M.J., Day S.J., Hansen S.C., Sushynski J.M., Bus J.S. Strategies to assess systemic exposure of chemicals in subchronic/chronic diet and drinking water studies. Toxicol. Appl. Pharmacol. 2006, 211:245-260.
22. SCCNFP, 2003. The SCCNFP's Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. 5th Revision. Adopted during the 25th plenary meeting of 20 October, 2003, p. 87. Available at:. http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out242_en.pdf.
23. SCCP, 2006. Scientific Committee on Consumer Products (SCCP) Opinion on p-Phenylenediamine. SCCP/0989/06. Available at:. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_069.pdf.
24. SCCP, 2008. Scientific Committee on Consumer Products (SCCP). Opinion on Camphor benzalkonium methosulfate. SCCP/1202/08. Available at:. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_168.pdf.
25. SCCS, 2010a. Scientific Committee on Consumer Safety. Notes of Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS, 7th revision. SCCS/1416/11. 14th December 2010. Available at:. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_004.pdf.
26. SCCS, 2010b. Scientific Committee on Consumer Safety. Opinion on Bis(butylbenzoate) diaminotriazine aminopropyltrisoloxane. Available at:. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_055.pdf.
27. SCCS, 2011. Scientific Committee on Consumer Safety (SCCS). Addendum to opinion No SCCP/1202/08 on Camphor benzalkonium methosulfate. Available at:. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_071.pdf.
28. SCCS, 2012a. Scientific Committee on Consumer Safety. Notes of Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS, 8th revision. SCCS/1501/12. 11th December 2012. Available at:. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_006.pdf.
29. SCCS, 2012b. Scientific Committee on Consumer Safety (SCCS). Opinion on p-Phenylenediamine. SCCS/1443/11. Available at:. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_094.pdf.
30. SCF, 2000. Reports of the Scientific Committee for Food. Opinion on the safety of use of betacarotene from all dietary sources. Report no. SCF/CS/ADD/COL/159 Final. Opinion adopted by the SCF on 7 September 2000. Available at:. http://ec.europa.eu/food/fs/sc/scf/out71_en.pdf.
31. SCP, 2001. Opinion of the scientific committtee on plants regarding the evaluation of 2,4-dichlorophenoxy acetic acid (2,4-D) in the context of council directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/2,4D/002-Final.
32. Smith D.A., Humphrey M.J., Charuel C. Design of toxicokinetic studies. Xenobiotica 1990, 20(11):1187-1199.
33. Solecki R., Davies L., Dellarco V., Dewhurst I., van Raaij M., Tritscher A. Guidance on setting of acute reference dose (ARfD) for pesticides. Food Chem. Toxicol. 2005, 43:1569-1593.
34. Timchalk C. Comparative inter-species pharmacokinetics of phenoxyacetic acid herbicides and related organic acids. evidence that the dog is not a relevant species for evaluation of human health risk. Toxicology 2004, 200:1-19.
35. WHO, 2005. Chemical-specific adjustment factors for interspecies differences and human variability: guidance document for use of data in dose/concentration-response assessment. Geneva. http://www.inchem.org/documents/harmproj/harmproj/harmproj2.pdf.