CoChat
Sign Up
Cited by 207Animal testing and alternativesAgricultural safety and regulationsEnvironmental Toxicology and Ecotoxicology

Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment

Open access
OECD·2005·OECD Series on Testing and Assessment
DOI 10.1787/e1f1244b-en
Open this paper in CoChat — free accountOpen PDF

Abstract

The purpose of this document is to provide guidance on issues related to the validation of new or updated test methods consistent with current approaches. This document provides a synopsis of the current state of test method validation, in what is a rapidly changing and evolving area. Guidance on the more general aspects of OECD Test Guideline development is provided in the OECD Guidance Document for the development of OECD Test Guidelines for the testing of chemicals. While the principles of validation as described in this document were written for biology-based tests, they may be applicable to other Test Methods.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1787/e1f1244b-en

Cites

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • To be adopted as an OECD Test Guideline, a test method needs to be validated according to OECD Guidance Document 34 (GD34), demonstrating relevance and reliability and establishing performance against reference materials.

    “To be adopted as an OECD TG, a test method needs to be validated according to OECD Guidance Document 34 (GD34) (OECD 2005), demonstrating the relevance and reliability of the method, as well as establishing its performance against reference materials.”

    From Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology (2025) · cites this paper as OECD 2005

    Paragraph 20 says sponsors should provide evidence of adequate validation and acceptable relevance and reliability before a method is recommended for adoption. The glossary describes reference chemicals used in validation, but the document does not make validation specifically according to GD34, or performance testing against reference materials in every case, a categorical requirement for adoption. Paragraph 134 also says completing validation studies before consideration as a Test Guideline is not currently required. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

  • Regulatory acceptance of imaging-based in vitro methods requires careful assessment of transferability and reproducibility within and between laboratories, as required for test method validation in GD34 (OECD 2005).

    “Obtaining regulatory acceptance for imaging-based in vitro methods necessitates careful assessment of transferability and reproducibility of the results within and between laboratories, as required for the test method validation in GD34 (OECD 2005).”

    From Bridging imaging-based in vitro methods from biomedical research to regulatory toxicology (2025) · cites this paper as OECD 2005

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

No references could be resolved yet.

Research works printed but not linked: 24

  1. OECD (1996). Report of the OECD Workshop on "Harmonisation of Validation and Acceptance Criteria for Alternative Toxicological Test Methods" (Solna Report). OECD, Paris, 1996 (60 pp). [ENV/MC/CHEM(96)9]
  2. OECD (2002). Report of the OECD Conference on "Validation and Regulatory Acceptance of New and Updated Methods in Hazard Assessment" that was held in Stockholm, Sweden, 6-8 March 2002. Stockholm Conference. [ENV/JM/TG/M(2002)2/ADD1]
  3. OECD (2004). Report of the Workshop on Data Interpretation Procedures (DIPs), held in Berlin, Germany 1-2 July, 2004. [ENV/JM/TG/M(2004)2]
  4. 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., and Walum, E. (1990a). Report and Recommendations of the CAAT/ERGATT Workshop on the "Validation of Toxicity Test Procedures". ATLA 18, 313-337.
  5. Balls, M., Botham, P., Cordier, A., Fumero, S., Kayser, D., Koëter, H.B.W.M., Koundakjian, P., Lindquist, L.G., Meyer, O., Pioda, L., Reinhardt, C., Rozemond, H., Smyrniotis, T., Spielmann, H., Van Looy, H., van der Venne, M.-T., and Walum, E. (1990b). Report and Recommendations of an International Workshop on "Promotion of the Regulatory Acceptance of Non-animal Toxicity Test Procedures. ATLA 18, 339-344.
  6. Worth, A.P. (2004). The Tiered Approach to Toxicity Assessment Based on the Integrated Use of Alternative (Non-animal) Tests. In Predicting Chemical Toxicity and Fate (M.T.D Cronin & D.J. Livingstone, eds). pp. 389-410. CRC Press; New York, London, Boca Raton.
  7. Dearden, J.C., Barratt, M.D., Benigni, R., Bristol, D.W., Combes, R.D., Cronin, M.T.D., Judson, P.N., Payne, M.P., Richard, A.M., Tichy, M., Worth, A.P. and Yourick, J.J. (1997). The development and validation of expert systems for predicting toxicity. The report and recommendations of an ECVAM/ECB workshop (ECVAM workshop 24). ATLA 25, 223-252. Available at: [http://ecvam.jrc.it:8080/publication/index24.html]
  8. Jaworska JS., Comber M, Auer C and van Leeuwen CJ (2003). Summary of a workshop on regulatory acceptance of (Q)SARs for human health and environmental endpoints. Environmental Health Perspectives 111, 1358-1360.
  9. CEFIC (2002) ICCA Workshop on "(Q)SARS for human health and the environment: workshop on regulatory acceptance". Held in Setubal, Portugal, March 4-6, 2002.
  10. Balls, M., Blaauboer, B.J., Fentem, J.H., Bruner, L., Combes, R.D., Ekwall, B., Fielder, R.J., Guillouzo, A., Lewis, R.W., Lovell, D.P., Reinhardt, C.A., Repetto, G., Sladowski, D., Spielmann, H., and Zucco, F. (1995). Practical aspects of the validation of toxicity test procedures. The Report and Recommendations of ECVAM Workshop 5. ATLA 23, 129-147. Available at: [http://ecvam.jrc.it:8080/publication/Workshopreport5.pdf]
  11. Smrchek, J.C. and Zeeman, M. 1998. Assessing risks to ecological systems from chemicals. In: Handbook of Environmental Risk Assessment and Management, P. Calow (ed.), Chapter 3, pp. 24-90. Blackwell Science Ltd., Oxford, UK.
  12. Cooper-Hannan, R., Harbell, J.W., Coecke, S., Balls, M., Bowe, G., Cervinka, M., Clothier, R., Hermann, F., Klahm, L.K., de Lange, J., Liebsch, M., and Vanparys, P. (1999). The principles of good laboratory practice: application to in vitro toxicology studies. The Report and Recommendations of ECVAM Workshop 37. ATLA 27, 539-577. Available at: [http://ecvam.jrc.it:8080/publication/index37.html]
  13. CETOC (2004) Workshop on the use of human data in risk assessment. Held on 23-24 February, 2004 in Cardiff, UK. Workshop Report No. 3. Available: [www.ecetoc.org]
  14. Recommendations on the Transport of Dangerous Goods -Model Regulations. United Nations. 12th Revised Edition. (2001). ST/SG/AC.10/1/Rev.12.
  15. Botham, P.A., Chamberlain, M., Barratt, M.D., Curren, R.D., Esdaile, D.J., Gardner, J.R., Gordon, V.C., Hildebrand, B., Lewis, R.W., Liebsch, M., Logemann, P., Osborne, R., Ponec, M., Regnier, J.F., Steiling, W., Walker, A.P., and Balls, M. (1995). A prevalidation study on in vitro skin corrosivity testing. The report and recommendations of ECVAM Workshop 6. ATLA 23, 219-255.
  16. OECD (1996). Final Report of the OECD Workshop (Solna Report) on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods, 62pp.
  17. Balls, M., Blaauboer, B.J., Fentem. J.H., Bruner. L., Combes, R.D., Ekwall, B., Fielder. R.J., Guillouzo, A., Lewis, R.W., Lovell, D.P., Reinhardt, C.A., Repetto, G., Sladowski. D., Spielmann, H., and Zucco, F. (1995). Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM workshops. ATLA 23, 129-147.
  18. Liebsch, M., Traue, D., Barrabas, C., Spielmann, H., Uphill, P., Wilkins, S., McPherson, J.P., Wiemann, C., Kaufmann, T., Remmele, M. and Holzhütter, H.-G. (2000). The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA 28, pp. 371-401.
  19. Marzulli, F.N., and Maibach, H.I. (Eds.). (1996). Dermatotoxicology, 5th Ed. Taylor & Francis, Washington, D.C. Sailstad, D., Hattan, D., Hill, R., and Stokes, W. (2000). The first method evaluation by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): The murine local lymph node assay (LLNA). In Progress in the Reduction, Refinement and Replacement of Animal Experimentation (M. Balls, A.-M. van Zeller, and M.E. Halder, Eds.), pp. 425-433. Elsevier Science, Amsterdam.
  20. Selgrade, M.J.K., Germolec, D.R., Luebke, R.W., Smialowicz, R.J., Ward, M.D., and Sailstad, D.M. (2001). Immunotoxicity. In Introduction to Biochemical Toxicology, 3rd Edition (E. Hodgson and R.C. Smart, Eds.), pp. 597-561.
  21. Stokes, W., and Hill, R. (2000). The role of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) in the evaluation of new toxicological testing methods. In Progress in the Reduction, Refinement and Replacement of Animal Experimentation (M. Balls, A.-M. van Zeller, and M.E. Halder, Eds.), pp. 385-394. Elsevier Science, Amsterdam.
  22. Sailstad, D., Hattan, D., Hill, R., and Stokes, W.S., Evaluation of the Murine Local Lymph Node Assay (LLNA) I: The ICCVAM Review Process. Regul. Toxicol. Pharmacol. 34(3):249-257, 2001.
  23. Dean, J., Twerdok, L., Tice, R., Sailstad, D., Hattan, D. and Stokes, W.S., Evaluation of the Murine Local Lymph Node Assay (LLNA) II: Conclusions and Recommendations of an Independent Scientific Peer Review Panel. Regul. Toxicol. Pharmacol. 34(3):258-273, 2001.
  24. Haneke, K., Tice, R., Carson, B., Margolin, B., and Stokes, W.S., Evaluation of the Murine Local Lymph Node Assay (LLNA): III. Data Analyses Completed by the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Regul. Toxicol. Pharmacol. 34(3):274-286, 2001.

Cited by

Sorted by citations

Authors
OECD
Corresponding author
OECD
Venue
OECD Series on Testing and Assessment
Publisher
OECD
Published
2005-08-18
ISSN
2077-7876 (ISSN-L)
DOI
10.1787/e1f1244b-en
OpenAlex
W4400154629
Cited by
207
References
0
Citations by year
2026: 16 · 2025: 29 · 2024: 9 · 2023: 6 · 2022: 8 · 2021: 11 · 2020: 11 · 2019: 11 · 2018: 21 · 2017: 8 · 2016: 11 · 2015: 16 · 2014: 10 · 2013: 7 · 2012: 8
FWCI
3.22
Type
book
Language
en
Open access
Licence
public-domain
Locations
OECD series on testing and assessment (publishedVersion, public-domain)
Funders
U.S. Environmental Protection Agency
Topics
  • Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
  • Physical Sciences › Environmental Science › Health, Toxicology and Mutagenesis › Environmental Toxicology and Ecotoxicology
Keywords
test method validation, OECD test guidelines, hazard assessment, chemical testing, test method development

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review