ASTM_E_1055_-_99_2003.pdf

Designation:E 1055 99(Reapproved 2003)Standard Test Method forEvaluation of Eye Irritation in Albino Rabbits1This standard is issued under the fixed designation E 1055;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method determines the duration and the nu-merical degree of eye irritation in young,adult albino rabbits.The test is an alternative method to the standard Draize eyeirritation method.Experimentation indicates that this proce-dure provides more realistic data,and therefore a better basisfor making predictions of eye responses from accidentalexposure in man.This test method is applicable to both liquidsand solids;it is not applicable to aerosols or vapors.1.2 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility the user of this standard to establish appropriatesafety and health practices and determine the applicability andregulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:E 609 Definition of Terms Relating to Pesticides2E 943 Terminology Relating to Biological Effects and En-vironmental Fate22.2Federal Standards:3Title 40 Code of Federal Regulations(CFR),EnvironmentalProtection Agency,Subchapter E,Pesticides Programs;Part 160,Good Laboratory Practice StandardsTitle 21 CFR,Food and Drug Administration,Part 58,Laboratory Practice for Nonclinical StudiesTitle 40 CFR,Toxic Substance ControlAct,Part 792,GoodLaboratory Practice Standards3.Summary of Test Method3.1 The test material is placed directly on the cornea of oneeye in each of six rabbits while the untreated eye serves as acontrol.The eyelid is released immediately after instillationwithout forced blinking or manipulation.3.2 The eyes are scored in accordance with the method ofDraize at 1,2,3,7,14,and 21 days following treatment.Scoring at other time intervals may be added as deemednecessary for certain materials.Scores are discontinued at anytime during the 21-day observation period if there is noperceivable evidence of irritation or at the end of the 21-dayobservation period.The daily total score for each eye iscalculated,and the daily arithmetic mean score for all eyes intest group is calculated.When the test is completed,the highestaverage score is determined.4.Significance and Use4.1 This test method evaluates the eye irritation elicited bya test substance when introduced into the eye of a rabbit.Forterminology see Terminology Standards E 609 and E 943.4.2 Results of testing by this test method can be used toestimate the potential for eye irritation or injury in humanswhen this material is accidentally introduced into the eye.4.3 The dose volume of 0.01 mL is used because thisamount provides a very good discrimination between sub-stances of moderate irritancy plus the ability to detect poten-tially severe irritants or corrosives.4,54.4 The dose volume of 0.01 is only one-tenth the volumespecified in the Draize rabbit eye irritation test and therebyproduces less ocular injury than the latter test.3This results ina more humane test with better discrimination between mod-erate irritants than with a 0.1 mL volume.6,71This test method is under the jurisdiction of ASTM Committee E35 on Pesti-cides and Alternative Control Agents and is the direct responsibility of Subcom-mittee E35.26 on Safety to Man.Current edition approved Oct.1,2003.Published October 2003.Originallyapproved in 1985.Last previous edition approved in 1999 as E 1055 99.2Annual Book of ASTM Standards,Vol 11.05.3Available from U.S.Government Printing Office,Superintendent of Docu-ments,Washington,DC 20402.4Committee for the Revision of NAS Publication#1138,“Principles andProcedures for Evaluating the Toxicity of Household Substances,”National Acad-emy of Sciences,1977,pp.4154.5Griffith,J.F.,et al.,“Dose-Response Studies with Chemical Irritants in theAlbino Rabbit Eye as a Basis for Selecting Optimum Testing Conditions forPredicting Hazard to the Human Eye,”Toxicity and Applied Pharmacology,Vol 55,1980,pp.501513.6Freeberg,F.E.,et al.,“Human and Rabbit Eye Responses to Chemical Insult,”Fundamental and Applied Toxicology,Vol 7,1986,pp.626634.7Freeberg,F.E.,et al.,“Correlation of Animal Eye Test Data with Human Ex-perience for Household Products:an Update,”Journal of Toxicology-Cutaneous andOcular Toxicology,Vol 5,1986,pp.115123.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.5.Interpretation of Results5.1 When the exposure of the eyes to a test material underthe specified conditions causes no significant ocular changes at24 h,the material is considered to produce no irritation.5.2 An eye response is characterized as moderate irritationwhen any of the following respons