Exposure-driven risk assessment: Applying exposure-based waiving of toxicity tests under REACH

Food and Chemical Toxicology

Volumn 49, Issue 8, 2011, Pages 1661-1673

  Rowbotham, Anna L ^a   Gibson, Rosemary M ^a  

^a HEALTH AND SAFETY LABORATORY   (United Kingdom)

Author keywords

Chemicals; Inhalation; Intelligent testing; Threshold of toxicological concern

Indexed keywords

AEROSOL; AIR POLLUTANT; CARCINOGENICITY; EXPERIMENTAL ANIMAL; EXPOSURE; EXPOSURE BASED WAIVING; FOOD AND DRUG ADMINISTRATION; FOOD CONTAMINATION; FOOD POISONING; GENOTOXICITY; HAZARD ASSESSMENT; HUMAN; LEGAL ASPECT; LUNG TOXICITY; MAXIMUM ALLOWABLE CONCENTRATION; NONHUMAN; PHYSICAL CHEMISTRY; QUANTITATIVE ANALYSIS; REVIEW; RISK ASSESSMENT; TOXICITY TESTING; TOXICOKINETICS;

AEROSOLS; AIR POLLUTANTS; ANIMALS; ANIMALS, LABORATORY; CONSUMER PRODUCT SAFETY; EUROPEAN UNION; GUIDELINES AS TOPIC; HAZARDOUS SUBSTANCES; HUMANS; INHALATION EXPOSURE; MODELS, BIOLOGICAL; POLICY; RISK ASSESSMENT; TOXICITY TESTS; TOXICOLOGY;

ANIMALIA; VERTEBRATA;

EID: 79958729740     PISSN: 02786915     EISSN: 18736351     Source Type: Journal    
DOI: 10.1016/j.fct.2011.03.050     Document Type: Review

References (35)

1. Barlow S, 2005. Threshold of toxicological concern (TTC). A tool for assessing substances of unknown toxicity present at low levels in the diet. ILSI Europe Concise Monograph Series, The International Life Sciences Institute (ILSI Europe).
2. 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. Toxicological Letters 2008, 176:68-76.
3. Bitsch A., Jacobi S., Melber C., Wahnschaffe U., Simetska N., Mangelsdorf REPDOSE: a database on repeated dose toxicity studies of commercial chemicals - a multifunctional tool. Regulatory Toxicology and Pharmacology 2006, 46:202-210.
4. Bulgheroni A., Kinsner-Ovaskainen A., Hoffmann S., Hartung T., Prieto P. Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats. Regulatory Toxicology and Pharmacology 2009, 53:16-19.
5. Bunke, D., Schneider, K., Jager, I. 2006. Exposure-based waiving: Concrete specifications of the waiving-conditions in the context of the registration procedure according to REACH. Institute for Applied Ecology. Downloaded from: http://www.oeko.de.
6. Carthew P., Griffiths H., Keech S., Hartop P. Safety assessment for hairspray resins: risk assessment based on rodent inhalation studies. Inhalation Toxicology 2002, 14:401-416.
7. 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 and Chemical Toxicology 2009, 47:1287-1295.
8. CFR United States Code of Federal Regulations 170.39. Threshold of regulation for substances used in food-contact articles. 21 CFR 170.39, page 17-20 2001, US Government Printing Office, Washington, DC.
9. Cheeseman M.A., Machuga E.J., Bailey A.B. A tiered approach to threshold of regulation. Food and Chemical Toxicology 1999, 37:387-412.
10. Cramer G.M., Ford R.A., Hall R.L. Estimation of toxic hazard - a decision tree approach. Food and Cosmetics Toxicology 1978, 16:255-276.
11. Drew R., Frangos J. The concentration of no toxicological concern (CoNTC): a risk assessment screening tool for air toxics. Journal of Toxicology and Environmental Health Part A 2007, 70:1584-1593.
12. EC, 2003. Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under council directive 91/414/EEC. Downloaded from: http://ec.europa.eu.
13. EC, 2006. Commission Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Regulation, Evaluation and Restriction of Chemicals (REACH). Downloaded from: http://eur-lex.europa.eu.
14. EC, 2009. Commission Regulation (EC) No 134/2009 of 16th February amending Regulation (EC) No 1907/2006 of the European Parliament and the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XI. Downloaded from: http://eur-lex.europa.eu.
15. Targeted risk assessment. Technical Report No. 93 2005, ECETOC, European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, Belgium.
16. EN481, 1993. European Standard EN481:1993 Workplace atmospheres - Size fraction definitions for measurement of airborne particles. Downloaded from: http://standards.mackido.com.
17. EPA, 2002. Guidance: Waiver Criteria for multiple-exposure inhalation toxicity studies. Office of Prevention, Pesticides and Toxic Substances. United States Environmental Protection Agency. HED SOP 2002: 01.
18. Escher S., Bitsch A., Batke M., Melber C., Simetska N., Mangelsdorf I. Influence of study parameters on TTC. Toxicology Letters 2008, 180(Suppl. 1):S61.
19. Escher S.E., Tluczkiewicz I., Batke A., Melber C., Kroese E.D., Buist H.E., Mangelsdorf I. Evaluation of inhalation TTC values with the database RepDose. Regulatory Toxicology and Pharmacology 2010, 58:259-274.
20. FDA (1995) Food additives: threshold of regulation for substances used in food-contact articles; Final Rule. Federal Register 60 36582-96.
21. Frawley J.P. Scientific evidence and common sense as a basis for food packaging regulations. Food and Cosmetics Toxicology 1967, 5:293-308.
22. Gold L.S., Sawyer C.B., Magaw R., Backman G.M., de Veciana M., Levinson R., Hooper N.K., Havender W.R., Bernstein L., Peto R., Pike M., Ames B.N. A carcinogenic potency database of the standardised results of animal bioassays. Environmental Health Perspectives 1984, 58:9-319.
23. Gold L.S., Manley N.B., Slone T.H., Garfinkel G.B., Ames B.N., Rohrbach L., Stern B.R., Chow K. Sixth plot of the carcinogenic potency database: results of animal bioassays published in the general literature 1989 to 1990 and by the National Toxicology Program 1990 to 1993. Environmental Health Perspectives 1995, 103:3-122.
24. Hofer T., Gerner I., Gundert-Remy U., Liebsch M., Schulte A., Spielman H., Vogel R., Wettig K. Animal testing and alternative approaches for human health risk assessment under the proposed new European chemicals regulation. Archives of Toxicology 2004, 78:549-564.
25. Kroes R., Galli C., Munro I., Schilter B., Tran L.A., Walker R., Wurtzen G. Threshold of toxicological concern for chemical substances in the diet: a practical tool for assessing the need for toxicity testing. Food and Chemical Toxicology 2000, 38:255-312.
26. 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 and Chemical Toxicology 2004, 42:65-83.
27. Kroes R., Kleiner J., Renwick A. The threshold of toxicological concern concept in risk assessment. Toxicological Sciences 2005, 86:226-230.
28. 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 and Chemical Toxicology 1996, 34:829-867.
29. Opinion of the Ad hoc working group for evaluation of the use of the Threshold of Toxicological Concern (TTC) principle in risk assessments performed by the Norwegian Scientific Committee for Food. Present and suggested use of the threshold of toxicological concern (TTC) principle in areas of risk assessment relevant for the Norwegian Scientific Committee for Food Safety (VKM). 24 May 2006 2006, NSCFS, Norwegian Scientific Committee for Food Safety, Oslo, Norway.
30. Schaafsma G., Kroese E.D., Tielemans E.L.J.P., van de Sandt J.J.M., van Leewen C.J. REACH, non-testing approaches and the urgent need for a change in mind set. Regulatory Toxicology and Pharmacology 2009, 53:70-80.
31. Steensberg J. Environmental health decision making. The politics of disease prevention. Scandinavian Journal of the Social Medicine Supplement 1989, 42:1-328.
32. Tielemans E., Warren N., Schneider T., Tischer M., Ritchie P., Goede H., Kromhout H., van Hemmen J., Cherrie J.W. Tools for regulatory assessment of occupational exposure: development and challenges. Journal of Exposure Science and Environmental Epidemiology 2007, 17:S72-S80.
33. TNsG, 2008. Technical Notes for Guidance on Data Requirements for Active Substances and Biocidal Products. Technical Guidance Document in Support of the Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market (Version 4.3.1). Downloaded from: http://ecb.jrc.ec.europa.eu.
34. Van der Jagt, K., Munn, S., Torslov, J., de Bruijn, J., 2004. Alternative approaches can reduce the use of test animals under REACH. Addendum to the report "Assessment of additional testing needs under REACH. Effects of (Q)SARs, risk based testing and voluntary industry initiatives" Report EUR 21405. European Commission, Joint Research Centre, Ispra, Italy.
35. Vermeire T.G., Bakker J., Bessems J.G.M., van de Bovenkamp M., Dang Z., van Engelen J.G.M., Gunnarsdottir S., Hagens W.I., Links I., Marquart H., Mikkers J., van Zijverden M. Exposure informed testing under REACH. RIVM report 601017001/2008 TNO-report V 8125 2008, National Institute for Public Health and the Environment, The Netherlands.