ASTM E1163-2010(2016) Standard Test Method for Estimating Acute Oral Toxicity in Rats《评价大鼠急性口服毒性的标准试验方法》.pdf

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1、Designation: E1163 10 (Reapproved 2016)Standard Test Method forEstimating Acute Oral Toxicity in Rats1This standard is issued under the fixed designation E1163; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis

2、ion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method determines the lethality (LD50 value,slope and 95 % confidence interval (CI) and signs of acutetoxicity from a

3、material using a limited number of rats. Thetechnique used in this test method is referred to as the“Stagewise, Adaptive Dose Method.”2This test method is analternative to the classical LD50 test and is applicable to bothliquids and solids.1.2 This test method is not recommended for test materialswh

4、ich typically produce deaths beyond two days postdosing.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-bilit

5、y of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:3E609 Terminology Relating to PesticidesIEEE/ASTM SI 10 Standard for Use of the InternationalSystem of Units (SI) (the Modernized Metric System)3. Terminology3.1 Definitions:3.1.1 delayed deathan animal which does not

6、 die orappear moribund within 24 h but dies later during the obser-vation period.3.1.2 gavageforced oral dosing, as by a tube that is passeddown the throat to the stomach.3.1.3 LD50the statistically derived estimate of the dose ofa test substance that would be expected to cause 50 % mortalityto the

7、test population under the specified test conditions.3.1.4 moribundat the point of death or extinction.3.1.5 pharmacotoxicgross physiological signs in responseto a toxic material.3.1.6 signs of toxicityobjective, observable evidence oftoxicity.3.1.7 suspensiona mixture in which very small particlesre

8、main suspended without dissolving.3.1.8 toxicitypoisonous quality.4. Summary of Test Method4.1 Three to five different doses of the target compound areselected such that the doses span the entire dose responsecurve, with separation between the doses to be equal logintervals. One to two animals are g

9、iven each dose as the firststage of the study. After 24 to 48 h, the responses to each doseare observed and used in determining the doses and animalnumbers in the next stage of dosing.4.2 The second and subsequent stages have one to fourdoses with one to three animals at each dose. Doses forsubseque

10、nt stages are selected based on the estimates of thedose response distribution parameters and the uncertainties ofthese estimates. The dose response curve and its parameters areupdated after each stage and dosing will stop when the 95 %confidence interval for the LD50 satisfies the following stop-pi

11、ng rule: (upper 95 % CI lower 95 % CI)/ (2 LD50) 5 g/kg).12. Calculation of Results12.1 Calculate the dose response curve and its parameters(slope, LD50 and 95 % CI) using nonlinear regression on a twoparameter (slope and intercept) probit model after each stageusing the dose, number exposed at the

12、dose, and numberresponding to the dose. As dosing continues with subsequentstages, all stages should be included in the determination of thedose response curve. Therefore, a stage effect should beincluded in the nonlinear regression to determine if responsesdiffer with respect to stage. If stage eff

13、ects are significant, astage may need to be excluded from the analysis. More specificdetails of the analysis approach are found in Feder.212.1.1 Additional toxicity tests should not be conducted ifthe existing test provides answers to all of the practicalquestions that need to be answered concerning

14、 the LD50.12.2 If the maximum number of animals has been used andan adequate LD50 and 95% CI cannot be estimated because thelive and dead animals have no doses in common and all deadanimals have higher doses and all live animals have lowerdoses, then LD50 may approximated by the average betweenthe t

15、wo doses were live and dead occur.12.3 If the maximum number of animals has been used andan adequate LD50 and 95% CI cannot be estimated because ofthe live and dead animals have no doses in common and alldead animals have higher doses and all live animals have lowerdoses, then LD50 may be approximat

16、ed by the averagebetween the two doses were live and dead occur.13. Report13.1 The report shall contain such information as testspecies and source and sex of animals.13.2 The report should include study initiation and termi-nation dates, individual body weights, dose levels, doseadministered, return

17、 to feeding time, mortality, pharmacotoxicsigns, gross necropsy results, and LD50, if determined.14. Precision and Bias14.1 A precision and bias statement cannot be made at thistime.15. Keywords15.1 chemicals; LD50; oral toxicity; pesticides; ratsASTM International takes no position respecting the v

18、alidity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is s

19、ubject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headq

20、uarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This stan

21、dard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 10 (2016)3