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Alternative Ocular Safety Testing References: The Bovine Corneal Opacity and Permeability (BCOP) Test Method

References cited in Background Review Document

  • AMCP Background Review Document (BRD). 2008. Submission to ICCVAM: An in vitro approach of EPA toxicity labeling of anti-microbial cleaning products and annexes A-G (http://iccvam.niehs.nih.gov/methods/ocutox/antimicro/BRD.pdf).
  • Bailey PT, Freeman JJ, Phillips RD, Merrill JC. 2004. Validation of the BCOP assay as a predictor of ocular irritation of various petrochemical products. Poster presentation at the Society of Toxicology 2004 meeting.
  • 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.
  • Berdasco N, Gilbert K, Lacher J, and Mattsson J. 1996. Low rate of severe injury from dermal and ocular irritation tests and the validity of using fewer animals. Journal of the American College of Toxicology. 15:177-193.
  • Calabrese EJ. 1983. Dermatotoxicity: Predictive Models. In: Principles of Animal Extrapolation. Wiley Interscience: New York.
  • Carpenter CP, Smyth HF. 1946. Chemical burns of the rabbit cornea. Am J Opthalmol. 29:60-73.
  • Cater KC and Harbell JW. 2006. Prediction of eye irritation potential of surfactant-based rinse-off personal care formulations by the bovine corneal opacity and permeability (BCOP) assay. Cut and Ocular Toxicol 25:217-233.
  • Cater KC and Harbell JW. 2008. Comparison of in vitro eye irritation potential by bovine corneal opacity and permeability (BCOP) assay to erythema scores in human eye sting test of surfactant-based formulations. Cut and Ocular Toxicol 27:77-85.
  • CPSC. 2003. Commercial practices. Hazardous Substances and Articles. 16CFR1500.42.
  • Debbasch C, Ebenhahn C, Dami N, Pericoi M, Van den Berghe C, Cottin M, and Nohynek GJ. 2005. Eye irritation of low-irritant cosmetic formulations: correlation of in vitro results with clinical data and product comparison. Food and Chem Toxicol. 43:155-165.
  • 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.
  • ECETOC. 1998. Eye Irritation – Reference Chemicals Data Bank. Technical Report No. 48(2). European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels.
  • EEC. 1984. Acute Toxicity – Eye Irritation. In Directive 67/548 (6th adaption); Annex V, Part B: Methods for the Determination of Toxicity. Official Journal of the European Community 27 L251, 109.
  • EEC. 1991. Classification of irritant substances and preparations. Official Journal of the European Community. L180, 52.
  • EPA. 1996. Label Review Manual. 2nd Edition. EPA737-B-96-001. U.S. Environmental Protection Agency:Washington, DC.
  • 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. Manual of Decisions for Implementation of the Sixth and Seventh Amendments to Directive 67/548/EEC on Dangerous Substances (Directives 79/831/EEC and 92/32/EEC). European Chemicals Bureau, IHCP, European Commission DG-JRC, report n. EUR 20519 EN, updated version of July 2004. Available: http://ecb.jrc.it/new-chemicals [accessed 14 October 2004].
  • FDA. 2003. Good laboratory practice for nonclinical laboratory studies. 21CFR58.
  • Gautheron P, Giroux J, Cottin M, Audegond L, Morilla A, Mayordomo-Blanco L, Tortajada A, Haynes G, Vericat JA, Pirovano R, Tos EG, Hagemann C, Vanparys P, Deknudt G, Jacobs G, Prinsen M, Kalweit S, Spielmann H. 1994. Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicol In Vitro 8(3):381-392.
  • 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 Authorization Act of 2000. 2000. Public Law 106-545 [114 Stat. 2721].
  • ICCVAM. 2006a. Background Review Document: Current Status of In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants: Bovine Corneal Opacity and Permeability Test Method. NIH Publication No: 06-4512. Research Triangle Park: National Toxicology Program.
  • 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.
  • Kay JH, Calandra JC. 1962. Interpretation of eye irritation tests. J Soc Cosmet Chem 13:281-289.
  • 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 and Koeter HB. 1993. Justification of the enucleated eye test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. 1993. Food Chem Toxicol. 31(1):69-76.
  • Prinsen MK. 2000. Chicken enucleated 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.
  • Russell WMS, Burch RL. 1992. The principles of humane experimental technique. 14th ed. Universities Federation for Animal Welfare: South Mimms, Potters Bar, Herts, England.
  • Sina JF, Galer DM, Sussman RG, Gautheron PD, Sargent EV, Leong B, Shah PV, Curren RD, Miller K. 1995. A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundam Appl Toxicol 26:20-31.
  • Southee JA. 1998. Evaluation of the Prevalidation Process. Part 2, final report. Volume 2. The Bovine Corneal Opacity and Permeability (BCOP) Assay. European Community Contract No. 11279-95-10F 1ED ISP GB.
  • Swanson JE, Harbell JW. 2000. Evaluating the eye irritancy potential of ethanolic test materials with the bovine corneal opacity and permeability assay. The Toxicologist 54(1):188-189.
  • Swanson JE, Lake LK, Donnelly TA, Harbell JW, Huggins J. 1995. Prediction of ocular irritancy of full-strength cleaners and strippers by tissue equivalent and bovine corneal assays. J Toxicol - Cut and Ocular Toxicol 14(3):179-195.
  • UN. 2007. Globally Harmonised System of Classification and Labelling of Chemicals (GHS). New York & Geneva:United Nations Publications.
  • Van Goethem F, Adriaens E, Alepee N, Straube F, De Wever B, Cappadoro M, Catoire S, Hansen E, Wolf A, and Vanparys P. 2006. Prevalidation of a new in vitro reconstituted human cornea model to assess the eye irritating potential of chemicals. Toxicol in Vitro. 20:1-17.

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