Oral acute toxic class method: A successful alternative to the oral LD 50 test

Regulatory Toxicology and Pharmacology

Volumn 42, Issue 1, 2005, Pages 15-23

  Schlede, Eva ^a   Genschow, Elke ^a   Spielmann, Horst ^a   Stropp, Gisela ^b   Kayser, Detlev ^a  

^a FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

^b Institute of Toxicology   (Germany)

Author keywords

Acute toxic class method; Alternative; Deletion of oral LD50 test; Globally harmonized classification system; Use for regulatory purposes

Indexed keywords

ANALYTIC METHOD; ARTICLE; BIOMETRY; EVALUATION; GERMANY; HUMAN; LD 50; MORTALITY; NONHUMAN; PRIORITY JOURNAL; SEQUENTIAL ANALYSIS; TOXICITY TESTING; VALIDATION PROCESS;

ACUTE TOXICITY TESTS; ADMINISTRATION, ORAL; ANIMALS; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; LETHAL DOSE 50; TOXICITY TESTS;

ANIMALIA;

EID: 19444382215     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.yrtph.2004.12.006     Document Type: Article

References (45)

1. C.I. Bliss The methods of probits Science 79 1934 38 39
2. Commission of the European Communities, 2001. Commission Directive 67/59/EEC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of laws, regulation and administrative provision relating to the classification, packaging and labelling of dangerous substances. Off. J. Eur. Comm. L225/1
3. Commission of the European Communities, 2004. Commission Directive 67/59/EEC of April 30, 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC on the approximation of laws, regulation and administrative provision relating to the classification, packaging and labelling of dangerous substances. Off. J. Eur. Comm. L152/173
4. W.B. Deichmann, and T.J. LeBlanc Determination of the approximate lethal dose with about six animals J. Indust. Hyg. Toxicol 25 1943 415 417
5. 50) and acute toxicity testing Toxicol. Lett. 49 1989 159 170
6. W. Diener, L. Siccha, U. Mischke, D. Kayser, and E. Schlede The biometric evaluation of the acute-toxic-class method (oral) Arch. Toxicol. 68 1994 599 610
7. W. Diener, U. Mischke, D. Kayser, and E. Schlede The biometric evaluation of the OECD modified version of the acute toxic class method (oral) Arch. Toxicol. 69 1995 729 734
8. W. Diener, D. Kayser, and E. Schlede The inhalation acute toxic class method: Test procedures and biometric evaluations Arch. Toxicol. 71 1997 537 549
9. W. Diener, D. Kayser, and E. Schlede The dermal acute toxic class method: Test procedures and biometric evaluations Arch. Toxicol. 72 1998 751 762
10. W. Diener Biometric evaluation of the ATC Method for the determination of the acute dermal toxicity of chemicals Biometrical J. 40 1998 979 991
11. 50 tests ALTEX 1 1999 129 134
12. EPA, 2002. Health Effects Test Guidelines, OPPTS 870.1100, Acute Oral Toxicity. Available from: 〈http://www.epa.gov/opptsfrs/ OPTS_Harmonized7870_Health_Effects_Test_Guidelines/Revised/870r-1100pdf〉
13. D.J. Finney Probit analysis third ed. 1971 Cambridge University Press Cambridge
14. Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity, National Toxicology Program P.O. Box 12233, Research Triangle Park, NC 27709 August 2001, NIH Publication No. 01-4500. Available from: 〈http://iccvam.niehs.nih.gov/methods/invidocs/guidance/iv_guide. pdf〉
15. W. Halle The registry of cytotoxicity:toxicity testing in cell cultures to predict acute toxicity (LD50) and to reduce testing in animals ATLA 31 2003 89 198 (Translated by Marlies Halder, Andrew Worth, and Elke Genschow)
16. H.C. Hodge, and J.H. Sterner Tabulation of toxicity classes Am. Ind. Hyg. Assoc. J. 10 1949 93 98
17. H.G. Holzhütter, E. Genschow, W. Diener, and E. Schlede Dermal and inhalation acute toxic class methods: Test procedures and biometric evaluations for the globally harmonized classification system Arch. Toxicol. 77 2003 243 254
18. D. Lorke A new approach to practical acute toxicity testing Arch. Toxicol. 54 1983 275 287
19. 50" determined with small number of animals Arch. Toxicol. 51 1982 189 196
20. OECD, 1981a. Guideline for the Testing of Chemicals: Acute Oral Toxicity (TG 401), adopted: 12 May 81. OECD, Paris
21. OECD, 1981b. Guideline for the Testing of Chemicals: Acute Inhalation Toxicity (TG 403), adopted: 12 May 81. OECD, Paris
22. OECD, 1981c. Guideline for the Testing of Chemicals: Acute Dermal Toxicity (TG 402), adopted: 12 May 81. OECD, Paris
23. OECD, 1996. Guideline for the Testing of Chemicals: Acute Oral Toxicity -Acute Toxic Class Method (TG 423), adopted 22.03.96. OECD, Paris
24. OECD, 1999. Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Monograph Series on Testing and Assessment No. 19. OECD, Paris
25. OECD, 2001a. Guideline for the Testing of Chemicals: Acute Oral Toxicity -Acute Toxic Class Method (TG 423), adopted 22.03.96: revised method adopted: 17th December 2001. OECD, Paris
26. OECD, 2001b. Guideline for the Testing of Chemicals: Acute Oral Toxicity -Fixed Dose Procedure (TG 420), adopted: 17.07.92; revised method adopted: 17th December 2001. OECD, Paris
27. OECD, 2001c. Guideline for the Testing of Chemicals: Acute Oral Toxicity -Up-and Down Procedure (TG 425), adopted: 21st September 1998; revised method adopted: 17th December 2001. OECD, Paris
28. OECD, 2001d. Harmonized Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures. Available from: 〈http://www1.oecd.org/ehs/class/Harmonizedintegrated.pdf〉 (Chapter 2.1). OECD, Paris
29. OECD, 2001e. Deletion of TG 401. C/M (2001) 26/PROV of 08-Jan-2002. OECD, Paris
30. OECD, 2001f. Guidance Document on Acute oral Toxicity Testing. ENV/JM/MONO(2001)4. OECD, Paris
31. J. Pauluhn, D. Bury, U. Föst, A. Gamer, E. Hoernicke, T. Hofmann, M. Kunde, T. Neustadt, E. Schlede, H. Schnierle, K. Wettig, and D. Westpfhal Acute inhalation toxicity testing. Considerations on technical and regulatory aspects Arch. Toxicol. 71 1996 1 10
32. Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity. National Toxicology Program, P.O. Box 12233, Research Triangle Park, NC 27709, August 2001, NIH Publication No. 01-4499. Available from: 〈http://iccvam.niehs.nih.gov/methods/invidocs/finalall.pdf〉
33. R. Roll, Th. Höfer-Bosse, and D. Kayser New perspectives in acute toxicity testing of chemicals Toxicol. Lett. Suppl. 31 1986 86
34. R. Roll, M. Riebschläger, U. Mischke, and D. Kayser Neue Wege zur Bestimmung der akuten Toxizität von Chemikalien Bundesgesundheitsblatt 32 1989 336 341
35. W.M.S. Russell, and R.L. Burch The principles of humane animal techniques 1959 Methuen London 238 pp
36. Schlede E., Genschow E., 2002. Acute Toxic Class Method, Design and Validation. ILSI Workshop "Putting Acute Oral Toxicity Guidelines into Practice, February 19-21, 2002, Bethesda, MD. Available from: 〈http://rsi.ilsi.org/events/actslist〉
37. 50 test Arch. Toxicol. 66 1992 455 470
38. E. Schlede, U. Mischke, W. Diener, and D. Kayser The international validation study of the acute toxic class method (oral) Arch. Toxicol. 69 1995 659 670
39. E. Schlede, I. Gerner, and W. Diener The use of humane endpoints in acute oral toxicity testing M. Balls A.-M. van Zeller M.E. Halder Progress in the reduction, refinement and replacement of animal experimentation 2000 Elsevier Science B.V. Amsterdam
40. E. Schütz, and H. Fuchs A new approach to minimizing the number of animals used in acute toxicity testing and optimizing the information of the test results Arch. Toxicol. 51 1982 197 220
41. Stropp, G., 2002. Acute Toxic Class Method, Practical Aspects and Implementation. ILSI Workshop "Putting Acute Oral Toxicity Guidelines into Practice, February 19-21, 2002, Bethesda, MD. Available from: 〈http://rsi.ilsi.org/events/actslist〉
42. J.W. Trevan The error of determination of toxicity Proc. R. Soc. CI. B 1927 483 514
43. H.D. Unkelbach, and T. Wolf Qualitative Dosis-Wirkungs-Analysen 1985 Gustav Fischer Verlag Stuttgart, New York
44. C.S. Weil, C.P. Carpenter, and H.F. Smyth The median effective dose Am. Ind. Hyg. Assoc. 14 1953 200 206
45. G. Zbinden, and M. Flury-Reversi Significance of the LD50-Test for the toxicological evaluation of chemical substances Arch. Toxicol. 47 1981 77 99