National Toxicology Program

Alternative Ocular Safety Testing References: The Low Volume Eye Test

References cited in Background Review Document

• Clean Air Act Amendments of 1990. Public Law 101-549.
• 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.
• Federal Environmental Pesticide Control Act. 1972. Public Law 92-516.
• Federal Insecticide, Fungicide and Rodenticide Act. 1947. Public Law 80-102.
• 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). 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. 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.