Acute oral toxicity: Variability, reliability, relevance and interspecies comparison of rodent LD50 data from literature surveyed for the ACuteTox project

Regulatory Toxicology and Pharmacology

Volumn 58, Issue 3, 2010, Pages 395-407

  Hoffmann, Sebastian ^a   Kinsner Ovaskainen, Agnieszka ^a   Prieto, Pilar ^a   Mangelsdorf, Inge ^b   Bieler, Christian ^b   Cole, Thomas ^a  

^a JOINT RESEARCH CENTRE   (Italy)

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

Author keywords

3Rs; Acute oral toxicity; Interspecies comparison; Reproducibility; Rodent LD50; Variability

Indexed keywords

ACETYLSALICYLIC ACID; ALCOHOL; ANTIBIOTIC AGENT; BENZENE; CHLOROFORM; CODEINE; CYCLOHEXIMIDE; CYCLOSPORIN A; DIAZEPAM; DICHLOROMETHANE; DIGOXIN; DIPHENHYDRAMINE; ETHYLENE GLYCOL; FLUORIDE SODIUM; FORMALDEHYDE; GLYCEROL; HALOPERIDOL; HEAVY METAL; HEXACHLOROBENZENE; INDUSTRIAL CHEMICAL; ISONIAZID; METHANOL; NICOTINE; PARACETAMOL; PESTICIDE; PHENOBARBITAL; POTASSIUM CHLORIDE; SELENATE; UNINDEXED DRUG; WARFARIN;

ARTICLE; CONTROLLED STUDY; CORRELATION ANALYSIS; IN VIVO STUDY; KLIMISCH RELIABILITY SCORE; LD 50; MAMMAL; NONHUMAN; PERFORMANCE; PREDICTION; PRIORITY JOURNAL; PROBABILITY; RELIABILITY; REPRODUCIBILITY; RODENT; SCORING SYSTEM; SPECIES DIFFERENCE; TOXICITY TESTING; ANIMAL; ANIMAL TESTING ALTERNATIVE; ANTIBODY SPECIFICITY; COMPARATIVE STUDY; FACTUAL DATABASE; HUMAN; METHODOLOGY; MOUSE; ORAL DRUG ADMINISTRATION; PRACTICE GUIDELINE; RAT; STATISTICS;

RATTUS; RODENTIA;

ACUTE TOXICITY TESTS; ADMINISTRATION, ORAL; ANIMAL TESTING ALTERNATIVES; ANIMALS; DATABASES, FACTUAL; GUIDELINES AS TOPIC; HUMANS; LETHAL DOSE 50; MICE; ORGAN SPECIFICITY; RATS; SPECIES SPECIFICITY;

EID: 79959511702     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2010.08.004     Document Type: Article

References (34)

1. Anon Directive 2003/15/EC of the European Parliament and the Council of 27 February amending Directive 76/786/EEC on the approximation of the laws of the member States relating to cosmetic products. Official J. Euro. Commun. 2003, L66:26-35.
2. Anon, 2006. Background Review Document (BRD): Validation of Neutral Red Uptake Test Methods. NIH Publication No. 07-4518 (accessed on 3 May 2010). http://iccvam.niehs.nih.gov/methods/acutetox/inv_nru_brd.htm.
3. Anon, 2007. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal of the European Union L396, 1-856. Office for Official Publications of the European Communities, Luxembourg.
4. Anon, 2008a. Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006. Official Journal of the European Union, L353 (vol. 51). Office for Official Publications of the European Communities, Luxembourg.
5. Anon, 2008b. ECHA guidance on dose response assessment. (accessed on 3 May, 2010). http://guidance.echa.europa.eu/docs/guidance_document/information_requir ements_r7_13_2_en.zip?vers=20_08_08.
6. Anon 2008c. Regulation (EC) No. 1336/2008 of the European Parliament and of the Council of 16 December 2008 amending Regulation (EC) No. 648/2004 in order to adapt it to Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures. Official Journal of the European Union, L354 (vol. 60). Office for Official Publications of the European Communities, Luxembourg.
7. Balls, M., Blaauboer, B., Brusick, D., Frazier, J., Lamb, D., Pemberton, M., Reinhardt, C., Roberfroid, M., Rosenkranz, H., Schmid, B., Spielmann, H., Stammati, A.-L. Walum, E., 1990. Report and recommendations of the CAAT/ERGATT workshop on validation of toxicity test procedures. Altern. Lab. Anim. (ATLA) 18, 303-337.
8. Balls, M., Blaauboer, B., Fentem, J.H., 1995. Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshop 5. Altern. Lab. Anim. (ATLA) 23, 129-147.
9. Clemedson C. The European ACuteTox project: a modern integrative approach to better prediction of acute toxicity. Clin. Pharmacol. Ther. 2008, 84(2):200-202.
10. 50 values and principal component analysis of results from six basal cytotoxicity assays, for use in the modelling of the in vivo and in vitro data of the EU ACuteTox Project. Altern. Lab. Anim. (ATLA) 2008, 36:503-519.
11. Cook R.D. Detection of influential observation in linear regression. Technometrics 1977, 19:15-18.
12. Dourson M.L., Stara J.F. Regulatory history and experimental support of uncertainty (safety) factors. Regul. Toxicol. Pharm. 1983, 3:224-238.
13. Ekwall B., Clemedson C., Crafoord B., Ekwall Ba., Hallander S., Walum E., Bondesson I. MEIC evaluation of acute systematic toxicity Part V. Rodent and human toxicity data for the 50 reference chemicals. Altern. Lab. Anim. (ATLA) 1998, 26:571-616.
14. 50 values and results from 61 in vitro methods. Altern. Lab. Anim. (ATLA) 1998, 26:617-658.
15. Ford J.H., Klomparens W. Cycloheximide (Acti-dione) and its nonagricultural uses. Antibiot. Chemother. 1960, 10:682-687.
16. Gold L.S., Bernstein L., Magaw R., Slone T.H. Interspecies extrapolation in carcinogenesis: prediction between rats and mice. Environ. Health Perspect 1989, 81:211-219.
17. 50) and to reduce testing in animals. Altern. Lab. Anim. (ATLA) 2003, 31:89-198.
18. Hoffmann S., Hartung T. Towards an evidence based toxicology. Hum. Exp. Toxicol. 2006, 25:497-513.
19. Hoffman R.S. Understanding the limitations of retrospective analyses of poison center data. Clin. Toxicol. 2007, 45:943-945.
20. Kinsner-Ovaskainen A., Bulgheroni A., Hartung T., Prieto P. ECVAM's ongoing activities in the area of acute oral toxicity. Toxicol. in Vitro 2009, 23:1535-1540.
21. Kinsner-Ovaskainen A., Rzepka R., Rudowski R., Coecke S., Cole T., Prieto P. Acutoxbase, an innovative database for in vitro acute toxicity studies. Toxicol. in Vitro 2009, 23:476-485.
22. Klimisch H.-J., Andreae M., Tillmann U. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul. Toxicol. Pharm. 1997, 25:1-5.
23. Lewis, R.J., 2004. Sax's Dangerous Properties of Industrial Materials, eleventh ed. Wiley - Interscience.
24. Organisation for Economic Cooperation and Development, 2001a. Guideline for the Testing of Chemicals 420 on Acute Oral Toxicity - Fixed Dose Procedure. Paris, France.
25. Organisation for Economic Cooperation and Development, 2001b. Guideline for the Testing of Chemicals 423 on Acute Oral Toxicity - Acute Toxic Class Method. Paris, France.
26. Organisation for Economic Cooperation and Development, 2001c. Guideline for the Testing of Chemicals 425 onAcute Oral Toxicity - Up- And Down Procedure. Paris, France.
27. Niedner R., Kayser M., Reuter N., Meyer F., Perkow W. Toxicity of warfarin and its effect on blood coagulation in rat and mice. Arzneimittelforschung 1973, 23(1):102.
28. Rudén C., Hansson S.O. How accurate are the European Union's classifications of chemical substances. Toxicol. Lett. 2003, 144:159-172.
29. Rousseeuw P.J. Least median of squares regression. J. Am. Stat. Assoc. 1984, 79:871-881.
30. Schneider K., Schwarz M., Burkholder I., Kopp-Schneider A., Edler L., Kinsner-Ovaskainen A., Hartung T., Hoffmann S. " ToxRTool" , a new tool to assess the reliability of toxicological data. Toxicol. Lett. 2009, 189:138-144.
31. Seidle, T., Robinson, S., Holmes, T., Creton, S., Prieto, P., Scheel, J., Chlebus, M., 2010. Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing Toxicol. Sci.; doi:. doi:10.1093/toxsci/kfq143.
32. Sjöström M., Kolman A., Clemedson C., Clothier R. Estimation of human blood LC50 values for use in modeling of in vitro-in vivo data of the ACuteTox project. Toxicol. in Vitro 2008, 22:1405-1411.
33. Travis C.C., Bowers J.C. Interspecies scaling of anesthetic potency. Toxicol. Ind. Health 1991, 7:249-260.
34. United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), ST/SG/AC.10/30/Rev.3 2009, United Nations publication, New York and Geneva.