ASTM_E_1103_-_96_2004e1.pdf

Designation:E 1103 96(Reapproved 2004)e1Standard Test Method forDetermining Subchronic Dermal Toxicity1This standard is issued under the fixed designation E 1103;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.e1NOTEEditorial changes were made throughout in February 2005.1.Scope1.1 This test method describes a procedure for the assess-ment and evaluation of the toxic characteristics of a testsubstance that is applied daily to the skin of experimentalanimals for 90 days.1.2 This test method is not capable of determining effectsthat have a long latency period(for example,carcinogenicity)or are life shortening.1.3 This test method is intended primarily to be used withrats,guinea pigs,or rabbits.Other species may be used withappropriate modifications.1.4 This standard does not purport to address the safetyconcerns,if any,associated with its use.It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E 609 Terminology Relating to PesticidesE 943 Terminology Relating to Biological Effects and En-vironmental Fate2.2Federal Standards:Title 21,Code of Federal Regulations(CFR),Food andDrug Administration,Part 58,Good Laboratory Practicefor Nonclinical Laboratory Studies3Title 40,Code of Federal Regulations(CFR),Environmen-tal Protection Agency,Part 798,Health Effects TestingGuidelines,Subpart C,Subchronic Exposure,Oral Toxic-ity3Title 40,Code of Federal Regulations(CFR),Environmen-tal Protection Agency,Part 798,Health Effects TestingGuidelines,Subpart B,General Toxicity Testing,AcuteDermal Toxicity3Title 40,Code of Federal Regulations(CFR),Environmen-tal Protection Agency,Subchapter E,Pesticide Programs;Part 160,Good Laboratory Practice Standards3Title 40,Code of Federal Regulations(CFR),Subchapter R,Toxic Substance Control Act,Part 792,Good LaboratoryPractice Standards33.Terminology3.1 DefinitionsFor definitions of terms used in this testmethod,see Terminology E 609 and E 943.3.2 Definitions of Terms Specific to This Standard:3.2.1 dose,dosage,nthe quantity of a substance appliedper unit treated or applied to or entered into organism.This isexpressed as the weight of the test substance per unit weight oftest animal(mg/kg).3.2.2 no observed adverse effect dose(NOAED),nthehighest tested dose of a substance at which the measuredbiological variables of a specific group under test conditionsshow no statistically significant dose-related adverse differencefrom the control treatment group.3.2.3 nulliparous,adjhaving never borne an offspring.3.2.4 test substance,npesticide or other material(ele-ment,chemical compound,formulation,known mixture)ad-ministered dermally for the purpose of determining subchronicdermal toxicity.4.Summary of Test Method4.1 The test substance is applied daily to the skin ingeometrically graduated doses to several groups of animals,one dose per group,for a period of 90 days.Generally at leastthree dose levels with a control and,where appropriate,avehicle control group are employed.4.2 Animals that die during the test are necropsied.At theconclusion of the test,the surviving animals are sacrificed andnecropsied and appropriate histopathological examinationsperformed.1This test method is under the jurisdiction of ASTM Committee E35 onPesticides and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.26 on Safety to Man.Current edition approved Nov.1,2004.Published November 2004.Originallyapproved in 1986.Last previous edition approved in 2000 as E 1103 96(2000).2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from U.S.Government Printing Office,Superintendent of Docu-ments,Washington,DC 20402.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.4.3 A limit test with one dose of at least 1000 mg/kg bodyweight can be conducted using the procedures described forthis method if no toxicity would be expected based upon dataof structurally related compounds.If this test produces noobservable toxic effects,then a full study using three doses isnot necessary.5.Significance and Use5.1 This test method provides information on health hazardslikely to arise from repeated exposure to a pesticide or otherchemical by the dermal route over a short time period.It mayprovide information needed to establish safety criteria forhuman exposure.5.2 Signs of toxicity other than lethality can be observed.5.3 This method can provide information on target