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Alternative Ocular Safety Testing References: The Isolated Chicken Eye (ICE) Test Method

References cited in Background Review Document

  • Balls M, Botham PA, Bruner LH, Spielmann H. 1995. The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol In Vitro 9:871-929.
  • Botham JW, McKillop CM, Purchase IFH. 1989. Acute and topical toxicity profiles for substances involved in the in vitro validation of the in vivo ocular irritation model. In: Collaborative Study on the Evaluation of Alternative Methods to the Eye Irritation Test. EC Document XI/632/91, V/E/1/131/91. Commission of the European Communities.
  • CPSC. 2003. Commercial practices. Hazardous Substances and Articles; Administration and Enforcement Regulations. 16 CFR 1500.42.
  • Draize J, Woodard G, Calvery H. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther 82:377-390.
  • EPA. 1996. Label Review Manual: 2nd Ed. EPA737-B-96-001. Washington:U.S. Environmental Protection Agency.
  • EPA. 1998. Health Effects Test Guideline, OPPTS 870.2400 Acute Eye Irritation. EPA 712- C-98-195. U.S. Environmental Protection Agency: Washington, DC.
  • EPA. 2003a. Good Laboratory Practice Standards. Toxic Substances Control Act. 40 CFR 792.
  • EPA. 2003b. Good laboratory practice standards. 40CFR160.
  • EU. 2001. Commission Directive 2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Communities L255:1-333.
  • EU. 2004. Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official Journal of the European Union L152:1-316.
  • FDA. 2003. Good laboratory practice for nonclinical laboratory studies. 21CFR58.
  • ICCVAM. 1997. Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods. NIH Publication No.: 97-3981. Research Triangle Park:National Toxicology Program.
  • ICCVAM. 2003. ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods. NIH Publication No: 03-4508. Research Triangle Park:National Toxicology Program.
  • ICCVAM. 2006a. Current Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Isolated Chicken Eye Test Method. NIH Publication No. 06-4513. Research Triangle Park, NC:National Institute of Environmental Health Sciences.
  • ICCVAM. 2006b. ICCVAM Test Method Evaluation Report: In Vitro Ocular Toxicity Methods for Identifying Severe Irritants and Corrosives. NIH Publication No: 07-4517. Research Triangle Park:National Toxicology Program.
  • ICCVAM Authorization Act of 2000. 2000. Public Law 106-545 [114 Stat. 2721].
  • INVITTOX. 1994. Protocol No. 80: Chicken enucleated eye test (CEET). Available: http://ecvam-sis.jrc.it/invittox/static/index.html. [accessed 18 February 2004].
  • MeSH Medical Subject Heading. Available: http://www.nlm.nih.gov/mesh [accessed 12 July 2005].
  • Occupational Safety and Health Act of 1970 (OSHA) (link to webpage on U.S. Occupational Safety and Health Administration website). 1970. Public Law 91-596
  • OECD. 1998. OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 1: OECD principles on Good Laboratory Practice (as revised in 1997). ENV/MC/CHEM(98)17. OECD, Paris.
  • OECD. 2002. Test guideline 405. Acute eye irritation/corrosion, adopted April 24, 2002. In: OECD Guidelines for Testing of Chemicals. OECD, Paris.
  • Prinsen MK. 1991a. Acute eye irritation/corrosion study with 1-butanol in albino rabbits. TNO-report V91.187/210069, November 1991. Dept. of Biological Toxicology, TNO Toxicology and Nutrition Institute, Zeist, The Netherlands. (Available on request)
  • Prinsen MK. 1991b. Acute eye irritation/corrosion study with 2-methoxyethanol in albino rabbits. TNO-report V91.188/210069, November 1991. Dept. of Biological Toxicology, TNO Toxicology and Nutrition Institute, Zeist, The Netherlands. (Available on request)
  • Prinsen MK. 1996. The chicken enucleated eye test (CEET): A practical (pre)screen for the assessment of eye irritation/corrosion potential of test materials. Food Chem Toxicol 34:291- 296.
  • Prinsen MK. 2000. Chicken encleated eye test with reference surfactants and siloxane polymers in Phase II of the reference standard validation project; an ex vivo alternative to the Draize eye irritation test with rabbits. TNO Report V99.521b. Unpublished report provided directly to NICEATM by M Prinsen, TNO Nutrition and Food Research Institute.
  • Prinsen MK. 2005. In vitro and in vivo data for 94 substances tested in the isolated chicken eye test. Unpublished data provided directly to NICEATM by MK Prinsen, TNO Nutrition and Food Research Institute.
  • Prinsen MK, Koëter BWM. 1993. Justification of the enucleated eye test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. Food Chem Toxicol 31:69-76.
  • Russell WMS, Burch RL. 1992. The Principles of Humane Experimental Technique. 14th ed. South Mimms, Potters Bar, Herts:Universities Federation for Animal Welfare.
  • UN. 2007. Globally Harmonised System of Classification and Labelling of Chemicals (GHS). New York & Geneva:United Nations Publications.
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