ASTM_E_1373_-_01.pdf

Designation:E 1373 01Standard 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.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:E 609 Terminology Relating to Pesticides2E 943 Terminology Relating to Biological Effects and En-vironmental Fate22.2Federal 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 diameterThe diameter of the unit den-sity sphere that has the same terminal settling velocity due togravity 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 concentrationThe amount of test substance admin-istered via inhalation for a period of 90 days.Express concen-tration as weight of the test substance per unit volume of air(for example,milligrams per liter,parts per million).3.1.3 geometric mean diameter or median diameterThecalculated 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 deviationThe measure of dis-persion 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 diameterThe aerodynamic diameter of aparticle that is considered to be inhalable for the organism.It isused 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 toxicityThe adverse effects caused whenthe inactivation or excretion,or both,of a substance is slowerthan the rate at which the substance is being administered.Since there is more of the substance entering the body than isbeing removed,a build up results,causing repeated dosage ofthe substance to produce a more marked response than after thefirst dose.3.1.7 no-observed-effect-level(NOEL)The maximum1This 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 Oct.10,2001.Published November 2001.Originallypublished as E 1373 90.Last previous edition E 1373 90(1996).2Annual Book of ASTM Standards,Vol 11.05.3Available 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.concentration used in a study that produces no observedeffects.3.1.8 subchronic inhalation toxic