References
Note: Many of the links on this page are to documents on the NICEATM-ICCVAM website, but some
links lead to items on pages outside the NICEATM-ICCVAM
website. They are provided for the convenience of visitors to this page, who may find them useful. NICEATM-ICCVAM
is not responsible for the availability or content of these external pages, nor do we endorse, warrant or guarantee
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Public Health and Human Poisonings
Bronstein AC, Spyker DA, Cantilena LR, Green J, Rumack BH, Heard, SE. 2006.
Annual Report of the American Association of Poison Control Centers’ National Poison Data System
(NPDS). Clin Toxicol 45:815–917.
[PDF]
IOM. 2004. Forging a Poison Prevention and Control System. Washington, DC: National Academies Press.
[PDF].
Lai MW, Klein-Schwartz W, Rodgers GC, Abrams JY, Haber DA, Bronstein AC, Wruk KM. 2006.
2005 Annual Report of the American Association of Poison Control Centers' National Poisoning and
Exposure Database. Clin Toxicol 44:803–932.
[PDF].
Collecting Biomarker Information: Methodologies and Selected Readings
International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI).
Development and
Application of Biomarkers of Toxicity.
Marusina K. 2006. Safety Biomarkers Holy Grail of Toxicology: Firms Develop New Technologies,
Big Pharma Collaborates, & the FDA Stresses Predictive Tests. Genetic Engineering and Biotechnology News.
Oct 15. Vol. 26. No. 18.
NIH. 2001. Biomarkers and Clinical Endpoints in Pediatric Clinical Trials
Patent Storm. 2005. Application of biosensors for diagnosis and treatment of disease.
Sackner, MA. 2003. Selected Annotated Bibliography for the Lifeshirt™ System. VivoMetrics, Inc.
Rolan P, Atkinson AJ, Lesko LJ. 2003. Use of biomarkers from drug discovery through clinical practice: Report of the Ninth
European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development. Clinical Pharmacology & Therapeutics 73:284–291.
U.S. Environmental Protection Agency (EPA). Human Health Research Program (HHRP). Biomarkers for Cumulative Risk.
Humane Endpoints
Humane Endpoints for Animals Used in Biomedical Research and Testing. ILAR Journal V41(2) 2000.
OECD. 2000. 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. Paris, France:Organisation for Economic Co-operation and
Development. [PDF]
Regulatory Testing and Animal Welfare. ILAR Journal V43 Supplement 2002.
Stokes WS. 2002. Humane Endpoints for Laboratory Animals Used in Regulatory Testing.
ILAR Journal V43 Supplement. S31-S38.[PDF ]
Acute Toxicity Test Guidelines – Oral
EPA. 2000. Health Effects Test Guidelines OPPTS 870.3050.
Repeated Dose 28–Day Oral Toxicity Study in Rodents. EPA 712–C–00–366.
Washington, DC: U.S. Environmental Protection Agency. [PDF]
EPA. 2002a. Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity Testing –
Background. EPA 712–C–02–189. Washington, DC: U.S. Environmental Protection Agency. [PDF]
EPA 2002b. Health Effects Test Guidelines OPPTS 870.1100 Acute Oral Toxicity.
EPA 712–C–02–190. Washington, DC: U.S. Environmental Protection Agency. [PDF]
OECD. 1995. Guideline for Testing of Chemicals, 407: Repeated Dose 28-day Oral Toxicity Study in Rodents.
Paris, France:Organisation for Economic Co-operation and Development. [PDF]
OECD. 2001a. Guideline for Testing of Chemicals, 420, Acute Oral Toxicity – Fixed Dose Method.
Paris, France:Organisation for Economic Co-operation and Development. [PDF]
OECD. 2001b. Guideline For Testing of Chemicals, 423, Acute Oral Toxicity –
Acute Toxic Class Method. Paris, France:Organisation for Economic Co-operation and Development. [PDF]
OECD. 2001c. Guideline for Testing of Chemicals, 425, Acute Oral Toxicity – Up-and-Down Procedure.
Paris, France:Organisation for Economic Co-operation and Development. [PDF]
OECD. 2001d. Guidance Document on Acute Oral Toxicity Testing. 24. Paris,
France:Organisation for Economic Co-operation and Development. [PDF]
Acute Toxicity Test Guidelines – Dermal
EPA. 1998a. Health Effects Test Guidelines OPPTS 870.1200 Acute Dermal Toxicity. EPA 712–C–98–192.
Washington, DC: U.S. Environmental Protection Agency. [PDF]
EPA. 1998c. Health Effects Test Guidelines OPPTS 870.3200 21/28-Day Dermal Toxicity. EPA 712–C–98–201.
Washington, DC: U.S. Environmental Protection Agency. [PDF]
Acute Toxicity Test Guidelines – Inhalation
EPA. 1998b. Health Effects Test Guidelines OPPTS 870-1300 Acute Inhalation Toxicity. EPA 712–C–98–193.
Washington, DC: U.S. Environmental Protection Agency. [PDF]
In Vitro Approaches
ACuteTox: Research Project for Alternative Testing - An In Vitro Test Strategy for Predicting Human Acute Toxicity.
An Integrated Project within the Sixth Framework Programme.
ICCVAM. 2001a. Report Of The International Workshop On In Vitro Methods For Assessing Acute Systemic Toxicity.
NIH Publication No. 01-4499.
Research Triangle Park, NC:National Institute for Environmental Health Sciences. [ PDF]
ICCVAM. 2001b. Guidance Document On Using In Vitro Data To Estimate In Vivo Starting Doses For Acute Toxicity.
NIH Publication No. 01-4500. Research Triangle Park, NC:National Institute for Environmental Health Sciences. [PDF]
In Vitro Methods for Acute Toxicity
Gennari A, van den Berghe C, Casati S, Castell J, Clemedson C, Coecke S, et al. 2004. Strategies to replace in vivo acute systemic toxicity testing.
The report and recommendations of ECVAM Workshop 50. Altern Lab Anim 32:437-459. Available at ECVAM Website.
ICCVAM. 2006a. ICCVAM Test Method Evaluation Report:
In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Toxicity Tests. NIH Publication No. 07-4519.
Research Triangle Park, NC:National Institute for Environmental Health Sciences. View Table of Contents Webpage.
ICCVAM. 2006b. Peer Panel Report: The Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for
Acute Oral Systemic Toxicity Testing. Research Triangle Park, NC:National Institute for Environmental Health Sciences. [PDF]
Alternative Test Methods
ICCVAM. 2001. The Revised Up-and-Down Procedure (UDP): A Test Method for Determining the Acute Oral Toxicity of Chemicals
(Volumes 1 and 2). NIH Publication No. 02-4501 - November 2001. Research Triangle Park, NC:National Institute for
Environmental Health Sciences.
ICCVAM. 2007. NICEATM-ICCVAM Five-Year Plan. Research Triangle Park,
NC:National Institute for Environmental Health Sciences.
General References
Committee on Toxicity Testing and Assessment of Environmental Agents, National Research Council. 2007.
Toxicity Testing in the Twenty-first Century: A Vision and a Strategy.
Washington, DC: National Academies Press.
EPA. 2007. EPA Categorization and Prioritization Community of Practice.
NTP. 2004a. Toxicology in the 21st century: The role of the National Toxicology Program. Research Triangle Park, NC:
National Institute for Environmental Health Sciences.
NTP. 2004b. A National Toxicology Program for the 21st Century: A Roadmap for the Future.
Solecki R, Davies L, Dellarco V, Dewhurst I, van Raaij M, Tritscher A. 2005. Guidance on setting of acute reference dose (ARfD) for pesticides. Food Chem Toxicol 43:1569–1593.
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