Using fewer animals to identify chemical eye hazards: Revised criteria necessary to maintain equivalent hazard classification

Regulatory Toxicology and Pharmacology

Volumn 61, Issue 1, 2011, Pages 98-104

  Haseman, Joseph K ^a   Allen, David G ^b   Lipscomb, Elizabeth A ^b   Truax, James F ^b   Stokes, William S ^c  

^a JK Haseman Consulting   (United States)

^b INTEGRATED LABORATORY SYSTEMS   (United States)

^c NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

Author keywords

CPSC; Eye irritant; FHSA; Hazard classification; Hazard labeling; Ocular safety testing

Indexed keywords

IRRITANT AGENT;

ANIMAL TESTING ALTERNATIVE; ANIMAL TESTING REDUCTION; ARTICLE; CHEMICAL ACCIDENT; DISEASE CLASSIFICATION; EXPERIMENTAL RABBIT; EYE EXAMINATION; EYE INJURY; HAZARD ASSESSMENT; INJURY SEVERITY; INTERMETHOD COMPARISON; NONHUMAN; PREDICTION; PRIORITY JOURNAL; PROCESS OPTIMIZATION; RISK ASSESSMENT; SCORING SYSTEM;

ADMINISTRATION, OPHTHALMIC; ANIMAL TESTING ALTERNATIVES; ANIMALS; CONSUMER PRODUCT SAFETY; DATABASES, FACTUAL; EYE; EYE DISEASES; GUIDELINES AS TOPIC; HAZARDOUS SUBSTANCES; IRRITANTS; RABBITS; UNITED STATES;

ANIMALIA; ORYCTOLAGUS CUNICULUS;

EID: 80052401633     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2011.06.006     Document Type: Article

References (18)

1. Animal Welfare Act, 2010 (amended). Public Law 89-544, 7 U.S.C. 2131 et seq.
2. ChemIDplus. Bethesda, MD, National Library of Medicine. Available: (accessed 20.05.11.). http://chem.sis.nlm.nih.gov/chemidplus/.
3. CPSC, 2010. Federal Hazardous Substances Act Regulations, 16 CFR 1500.
4. deSilva O., et al. Evaluation of eye irritation potential: statistical analysis and tier testing strategies. Food Chem. Toxicol. 1997, 35:159-164.
5. DeSousa D., et al. Statistical consequences of reducing the number of rabbits utilized in eye irritation testing: data on 67 petrochemicals. Toxicol. Appl. Pharmacol. 1984, 76:234-242.
6. EPA Health Effects Test Guideline, OPPTS 870.2400 Acute Eye Irritation 1998, U.S. Environmental Protection Agency, Washington, DC.
7. FHSA, 2008 (amended). Public Law 86-613. 15 U.S.C. 1261-1278.
8. McGwin G., et al. Invest. Ophthalmol. Vis. Sci. 2006, 47:521-527.
9. McGwin G., et al. J. Safety Res. 2006, 37:501-506.
10. MeSH (Medical Subject Headings). National Library of Medicine, Bethesda, MD. Available: (accessed 20.05.11.). http://www.nlm.nih.gov/mesh.
11. OECD Council Act, Mutual Acceptance of Data 1981, Organisation for Economic Co-operation and Development, Paris.
12. OECD Test Guideline 405, Acute Eye Irritation/Corrosion 1987, Organisation for Economic Co-operation and Development, Paris.
13. OECD Detailed Review Document on Classification Systems for Eye/Irritation/Corrosion in OECD Member Countries. OECD Series on Testing and Assessment, No. 14. ENV/JM/MONO(99)4 1999, Organisation for Economic Co-operation and Development, Paris.
14. OECD Test Guideline 405, Acute Eye Irritation/Corrosion 2002, Organisation for Economic Co-operation and Development, Paris.
15. PHS, 2000. 42 U.S.C. 289d. Subchapter III-National research institutes; Part H-General provisions; Section 289d-Animals in research.
16. PHS, 2002. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Office of Laboratory Animal Welfare, National Institutes of Health, Department of Health and Human Services, Bethesda, MD.
17. Springer J., et al. Number of animals for sequential testing. Food Chem. Toxicol. 1993, 31:105-109.
18. Talsma D., et al. Reducing the number of rabbits in the Draize eye irritancy test: a statistical analysis of 155 studies conducted over 6 years. Fundam. Appl. Toxicol. 1988, 10:146-153.