1、Designation:E 1483 92(Reapproved 2000)Standard Test Method forAssessing Developmental Toxicity in Rats and Rabbits1This standard is issued under the fixed designation E 1483;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of
2、 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 is designed to assess the potential of apesticide or chemical to present a hazard to the unborn arisingf
3、rom exposure of the maternal animal during pregnancy.1.2 This test method assumes that the user is knowledgeablein animal toxicology and related pertinent areas,and it reliesheavily on the judgment of the evaluator.1.3 The values stated in SI units are to be regarded as thestandard.The values given
4、in parentheses are for informationonly.1.4 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 limi
5、tations prior to use.For specific hazardstatements,see Section 6.2.Referenced Documents2.1 ASTM Standards:E 609 Terminology Relating to Pesticides2E 943 Terminology Relating to Biological Effects and En-vironmental Fate22.2Federal Standards:Title 40,Code of Federal Regulations(CFR),Environmen-tal Pr
6、otection Agency,Subchapter E,Pesticide Programs:Part 160,Good Laboratory Practice Standards3Title 21,Code of Federal Regulations(CFR),Food andDrug Administration,Part 58,Good Laboratory Practicefor Nonclinical Studies3Title 40,Code of Federal Regulation(CFR),Toxic Sub-stance Control Act,Part 792,Goo
7、d Laboratory PracticeStandards33.Terminology3.1 Definitions:3.1.1For definitions of terms used in this test method,seeTerminology E 609 and E 943.3.1.2 developmental toxicitythe property of a test sub-stance that causes in utero death,structural or functionalabnormalities(teratogenic),or growth reta
8、rdation during theperiod of fetal development.To assess that property,the testsubstance is administered to the maternal animal during theperiod of major organogenesis.4.Summary of Test Method4.1 Rats and rabbits have been used extensively as animalmodels to determine whether a test substance is pote
9、ntiallyhazardous to the developing fetus.The use of two species isdesirable because of differences in maternal and fetal metabo-lism,placental barriers,and chemical absorption.4.2 The test substance is administered in graded doses togroups of pregnant animals from the time of embryonicimplantation t
10、hrough the period during which major organsystems are formed.At least 20 pregnant rats and 12 pregnantrabbits are required for each of the three test groups and thecontrol group.4.3 A pilot study is conducted to establish the three doselevels for the full study.4.4 On Day 20 of gestation for rats an
11、d Day 29 for rabbits,the pregnant females are sacrificed,the uteri are removed,andthe contents are examined for embryonic or fetal deaths andlive fetuses.Collected fetuses are weighed,measured,tagged,and sacrificed in preparation for complete examination.4.5 If a limit test at an exposure of least 1
12、000 mg/kg bodyweight produces no observable toxicity,a full study using threedose levels might not be necessary.5.Significance and Use5.1 In the assessment and evaluation of the toxic character-istics of a chemical,determination of the potential develop-mental toxicity is significant.5.2 This test m
13、ethod is intended to permit the determinationof a no-observed-effect level and the potential hazard to theunborn that may arise from exposure of the pregnant organismduring gestation.6.Hazards6.1 Contact with all test substances and solutions should beminimized with appropriate protective clothing,g
14、loves,eyeprotection,etc.The use of fume hoods and increased ventila-tion in test rooms is necessary when handling volatile sub-stances.Information on acute mammalian toxicity and specialhandling procedures for all chemicals and products to be usedshould be known before this test method is employed.1
15、This 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 June 15,1992.Published August 1992.2Annual Book of ASTM Standards,Vol 11.05.3Available from U.S.Government Printing Office,S
16、uperintendent of Docu-ments,Washington,DC 20402.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.6.2 The disposal of excess test substance,solutions,diets,excreta,and treated animals should be performed with consid-eration for health and environmental safety,and in accordancewith all federal,state,and local regulations.7.Facilities7.1 No precise physical requirements concerning animalsare set forth.However,the animal facility shall meet theestablished standard
