ASTM_E_1373_-_01_2005e1.pdf

Designation:E 1373 01(Reapproved 2005)e1Standard Test Method forConducting a Subchronic Inhalation Toxicity Study in Rats1This standard is issued under the fixed designation E 1373;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.e1NOTESection 3 was editorially corrected in November 2005.1.Scope1.1 This test method determines the no observed-effect level(NOEL)and toxic effects associated with continuous or re-peated inhalation exposure to a chemical,pesticide,or mixturefor a period of 90 days.The test is not capable of determiningthose effects that have a long latency period for development(for example,carcinogenicity and life shortening).1.2 This test method which is applicable to a gas,vapor,aerosol,or particulate is conducted after initial information ontoxicity is obtained by acute testing.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations 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:OPPTS 870-3465,EPA 712-C98-20490 day InhalationToxicity.Health Effects Test Guidelines,Office of Preven-tion,Pesticides and Toxic Substances,US EnvironmentalProtection Agency(USEPA)3Title 40,Code of Federal Regulations(CFR),Environmen-tal Protection Agency,Subchapter E,Pesticide Programs;Part 160,Good Laboratory Practice Standards4Title 21,Code of Federal Regulations(CFR),Food andDrug Administration,Part 58,Laboratory Practice forNonclinical Laboratory Studies4Title 40,Code of Federal Regulations(CFR),Toxic Sub-stance Control Act,Part 792,Good Laboratory PracticeStandards43.Terminology3.1 DefinitionsRefer to Definitions E 609 and Terminol-ogy E 943.3.1.1 aerodynamic diameter,nThe diameter of the unitdensity sphere that has the same terminal settling velocity dueto gravity as the particle under consideration,whatever its size,shape and density.It is used to compare particles of differentsize and densities and to predict where in the respiratory tractsuch particles may be deposited.5,63.1.2 concentration,nThe amount of test substance ad-ministered via inhalation for a period of 90 days.Expressconcentration as weight of the test substance per unit volume ofair(for example,milligrams per liter,parts per million).3.1.3 geometric mean diameter or median diameter,nThecalculated aerodynamic diameter that divides the particles ofan aerosol in half,based on the weight of the particles.Fiftypercent of the particles by weight will be larger than themedian diameter and 50%of the particles will be smaller thanthe median diameter.The median diameter describes theparticle size distribution of any aerosol based on the weight andsize of the particles.3.1.4 geometric standard deviation,nThe measure ofdispersion for a log-normal distribution,the ratio of the 84.13percentile to the 50 percentile and 50 percentile to the 15.8percentile.3.1.5 inhalable diameter,nThe aerodynamic diameter ofa particle that is considered to be inhalable for the organism.Itis used to refer to particles that are capable of being inhaled anddeposited anywhere within the respiratory tract from thetrachea to the alveoli.For man,inhalable diameter is consid-ered as 15 m or less(see CFR Title 40,Part 798).3.1.6 cumulative toxicity,nThe adverse effects causedwhen the inactivation or excretion,or both,of a substance is1This test method is under the jurisdiction of ASTM Committee E35 onPesticides and is the direct responsibility of Subcommittee E35.26 on Safety to Man.Current edition approved Nov.1,2005.Published November 2005.Originallyapproved in 1990.Last previous edition approved in 2001 as E 1373 01.2For 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 Environmental Protection Agency Ariel Rios Building 1200Pennsylvania Avenue,N.W.Washington,DC 20460(202)260-20904Available from U.S.Government Printing Office,Superintendent of Docu-ments,Washington,DC 20402.5Hinds,William C.,Aerosol Technology,Properties,Behavior,and Measure-ment of Airborne Particles,John Wiley&Sons,1982.6Richard,D.,Handbook on Aerosols,U.S.Energy Research and DevelopmentAdministration,1976.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.slower than the rate at which the substance is being adminis-tered.Since there is more of the substance entering the body