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Peer Review Panel Meeting on Alternative Ocular Test Methods

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Alternative Ocular Safety Testing References: The Low Volume Eye Test

References cited in Background Review Document

Click on link in author or agency name to view reference where available
  • Clean Air Act Amendments of 1990. Public Law 101-549. (View webpage on EPA website)
  • CPSC. 1995. Test for eye irritants. 16CFR1500.42.
  • 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. 1998. Health Effects Test Guideline, OPPTS 870.2400 Acute Eye Irritation. EPA 712- C-98-195. U.S. Environmental Protection Agency: Washington, DC.
  • EPA. 2003. Label Review Manual: 3rd Ed. EPA735-B-03-001. Office of Prevention, Pesticides and Toxic Substances. Washington: U.S. Environmental Protection Agency.
  • 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.
  • FDA. 1938. Food, Drug and Cosmetic Act of 1938. Public Law 75-717. (View webpage on FDA website)
  • Federal Environmental Pesticide Control Act. 1972. Public Law 92-516.
  • Federal Insecticide, Fungicide and Rodenticide Act. 1947. Public Law 80-102. (View webpage on EPA website)
  • FHSA. 1964. Federal Hazardous Substances Act. Public Law 86-613.
  • Freeberg FE, Griffith JF, Bruce RD, Bay PHS. 1984. Correlation of animal test methods with human experience for household products. J Toxic Cut. & Ocular Toxic. 1:53-64.
  • Freeberg FE, Nixon GA, Reer PJ, Weaver JE, Bruce RD, Griffith JF, et al. 1986a. Human and rabbit eye responses to chemical insult. Fundam Appl Toxicol 7: 626-634.
  • Freeberg FE, Hooker DT, Griffith JF. 1986b. Correlation of animal test methods with human experience for household products: an update. J. Toxic. Cut. & Ocular Toxic. 5:115-123.
  • Gettings SD, Lordo RA, Demetrulias J, PI Feder, Hintze KL. 1996. Comparison of low-volume, Draize and in vitro eye irritation test data. I. Hydroalcoholic formulations. Food Chem Toxicol 737-749.
  • Gettings S, Lordo R, Hintze K, Bagley D, Casterton P, Chudkowski M, et al. 1996. The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) surfactant-based formulations. Food Chem Toxic 34:79-117.
  • Ghassemi A, Sauers LH, Bruner LH, Reer PJ, Hall RH. 1993. Demonstrating the human safety of a new household cleaning (HSC) product using alternatives to the Draize eye irritation test. Presentation made at the U.S. Society of Toxicology meeting.
  • Grant W. 1974. Toxicology of the Eye, 2nd ed. Charles C. Thomas, Springfield, IL.
  • Griffith J, Nixon G, Bruce R, Reer P, Bannan E. 1980. Dose-response studies with chemical irritants in the albino rabbit eye as a basis for selecting optimum testing conditions for predicting hazard to the human eye. Toxic Appl Pharmacol 55:501-513.
  • McLaughlin R. 1946. Chemical burns of the human cornea. Am J Ophthamol 29:1355-1362.
  • OECD. 2002. Test guideline 405, Acute eye irritation/corrosion, adopted February 24, 1987. In OECD Guidelines for Testing of Chemicals. OECD, Paris.
  • 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
  • Roggeband R, York M, Pericoi M, Braun W. 2000. Eye irritation responses in rabbit and man after single applications of equal volumes of undiluted model liquid detergent products. Food Chem Toxic 38:727-734.
  • Toxic Substances Control Act of 1976 (link to webpage on U.S. Government Printing Office Access GPO website). 1976. Public Law 94-469.
  • UN. 2003. Globally Harmonised System of Classification and Labelling of Chemicals (GHS). New York, Geneva:United Nations Publications.
  • Wilhelmus K. 2001. The Draize eye test. Survey of Ophthalmology. 45: 493-515.

Supplemental References

  • Chiou GCY. 1999. Ophthalmic Toxicology - Target Organ Toxicology Series (Hayes AW, Thomas JA, Gardner DG, series eds). Philadelphia, PA: CRC Press.
  • Gettings SD, Lordo RA, Feder PI, Hintze KL. 1998. A comparison of low volume, Draize and in vitro eye irritation test data. III. Surfactant-based formulations. Food Chemical Toxicology 36:209-231.
  • Jester JV. 2006. Extent of corneal injury as a biomarker for hazard assessment and the development of alternative models to the Draize rabbit eye test. Cutaneous and Ocular Toxicology, 25: 41-54.
  • Maurer JK, Molai A, Parker RD, Li L, Carr GJ, Petroll WM, et al. 2001. Pathology of ocular irritation with bleaching agents in the rabbit low-volume eye test. Toxicologic Pathology 29:308-319.
  • Maurer JK, Molai A, Parker RD, Li L, Carr GJ, Petroll WM, et al. 2001. Pathology of ocular irritation with acetone, cyclohexanol, parafluoroaniline, and formaldehyde in the rabbit low-volume eye test. Toxicologic Pathology 29:187-199.
  • Maurer JK, Parker RD, Jester JV. 2002. Extent of initial corneal injury as the mechanistic basis for ocular irritation: key findings and recommendations for the development of alternative assays. Regulatory Toxicology and Pharmacology 36:106–117.
  • McGwin G, Hall TA, Xie A, Owsley C. 2006. Trends in Eye Injury in the United States, 1992–2001. Investigative Ophthalmology and Visual Science 47:521-527.
  • Wagoner MD. 1997. Chemical injuries of the eye: current concepts in pathophysiology and therapy. 1997. Surv Ophthalmol 41:275-313.

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