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Alternative Ocular Safety Testing References: In Vitro Strategy for EPA Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products

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.
  • Brantom, PG, Bruner, LH, Chamberlain M, de Silva O, Dupuis J, Earl LK, Lovell DP, Pape WJW, Uttley M, Bagley DM, Baker FW, Bracher, M, Courtellemont P, Declercq L, Freeman S, Steiling W, Walker AP, Carr GJ, Dami N, Thomas G, Harbell J, Jones PA, Pfannenbecker U, Southee JA, Tcheng M, Argembeaux H, Castelli D, Clothier R, Esdaile DJ, Itigaki H, Jung, Y. Kasai, H. Kojima, U. Kristen, l.M. Larnico, R.W. Lewis, K. Marenus, Moreno O, Peterson KA, Rasmussen ES, Robles C and Stern MA. 1997. Summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicol In Vitro 11:141-179.
  • 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. 2003a. Good Laboratory Practice Standards. Toxic Substances Control Act. 40 CFR 792.
  • EPA. 2003b. Good laboratory practice standards. 40CFR160.
  • EPA. 2003c. EPA Label Review Manual, 3rd Edition. U.S. Environmental Protection Agency, Office of Prevention, Pesticides & Toxic Substances (OPPTS). EPA 735-B-03-001. August 2003. Washington, DC:U.S. Environmental Protection Agency.
  • FDA. 2003. Good laboratory practice for nonclinical laboratory studies. 21CFR58.
  • Federal Insecticide, Fungicide and Rodenticide Act. 1947. Public Law 80-102.
  • FHSA. 1964. Federal Hazardous Substances Act. Public Law 86-613.
  • Gautheron P, Giroux J, Cottin M, Audegond L, Morilla A, Mayordomo-Blanco L, et al. 1994. Interlaboratory assessment of the bovine corneal opacity and permeability (BCOP) assay. Toxicol In Vitro 8:381-392.
  • Gettings S, Lordo R, Hintze K, Bagley D, Casterton P, Chudkowski M, Curren RD, Demetrulias JL, Dipasquale LC, Earl LK, Feder PI, Galli CL, Glaza SM, Gordon VC, Janus J, Kurtz PJ, Marenus KD, Moral J, Pape WJW, Renskers KJ, Rheins LA, Roddy MT, Rozen MG, Tedeschi JP, Zyracki J. 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.
  • Griffith JF, Nixon GA, Bruce RD, Reer PJ, Bannan EA. 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. Tox Appl Pharmacol 55:501-513.
  • 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: Bovine Corneal Opacity and Permeability Test Method. Vol. 1/2. NIH Publication No. 06-4512. Research Triangle Park, NC:National Institute of Environmental Health Sciences.
  • ICCVAM. 2006e. ICCVAM Test Method Evaluation Report. In vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives. NIH Publication No. 07-4517. Research Triangle Park, NC:National Institute of Environmental Health Sciences.
  • Occupational Safety and Health Act of 1970 (OSHA). 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.
  • Southee JA. 1998. Evaluation of the Prevalidation Process. Part 2, final report. Volume 2. The Bovine Corneal Opcity and Permeability (BCOP) Assay. European Community Contract No. 11279-95-10F 1ED ISB GB.
  • Toxic Substances Control Act of 1976 (link to webpage on U.S. Government Printing Office Access GPO website). 1976. Public Law 94-469.
  • UN. 2007. Globally Harmonised System of Classification and Labelling of Chemicals (GHS) – “The Purple Book.” New York & Geneva:United Nations Publications.
  • Wilhelmus KR. 2001. The Draize eye test. Surv Ophthalmol 45(6):493-515.

Supplemental References

Information on the Bionas Analyzing System

  • Thedinga E, et al. 2007. Online monitoring of cell metabolism for studying pharmacodynamic effects. Toxicol Appl Pharmacol 220:33-44.
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