ASTM F719-1981(2007)e1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation《用兔作生物材料试验对皮肤的刺激》.pdf

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1、Designation: F 719 81 (Reapproved 2007)e1Standard Practice forTesting Biomaterials in Rabbits for Primary Skin Irritation1This standard is issued under the fixed designation F 719; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, th

2、e 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.e1NOTEFormatting and grammar were corrected editorially throughout in April 2007.1. Scope1.1 This practice covers a pro

3、cedure by which the irritancyof a biomaterial may be assessed through contact with abradedand intact skin of rabbits.1.2 The results of this practice depend upon the effective-ness with which contact between the skin and the test materialis established and maintained. Because of the operator tech-ni

4、que included in performing this test, it is important that thetest be performed by personnel with appropriate training.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-pri

5、ate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F 619 Practice for Extraction of Medical Plastics3. Summary of Practice3.1 Exposure of skin to the test material is accomplished bymeans of a patch test

6、technique employing two intact and twoabraded sites on the back of each of six albino rabbits. The skinis clipped free of hair one day prior to testing. The testsubstance is applied using 0.5 mL for liquids, 0.5 g for solidsor semisolids, and a 2.5 by 2.5-cm square patch for films. Afterapplication,

7、 each test site is covered with a 2.5 by 2.5-cm gauzeflat, and the entire trunk is occluded with a polyethylene sleeve.After 24 h, the sleeve, flat, and test material are removed, andtest sites are evaluated for erythema and edema.4. Significance and Use4.1 Materials that are to be in contact with t

8、he skin shouldnot cause irritation to the skin. Since it is probably thesubstances leached from a material that cause the irritation, thispractice provides for direct material-skin contact testing or forskin exposure to the liquid extract of the test material. Therationale for this rabbit test is th

9、at it is a comparatively quickand inexpensive method which, through use over the years, hasbecome a generally accepted method.5. Materials and Manufacture5.1 Young New Zealand Albino Rabbits,5.2 Gauze Flats, 2.5 by 2.5-cm,5.3 Polyethylene Sleeves, extra clear, and5.4 Adhesive Tape,12-in.6. Test Spec

10、imen6.1 The test specimen may be one of three forms:6.1.1 Test 0.5 mL of liquids or saline extract liquids ob-tained in accordance with Practice F 619.6.1.2 Test 0.5 g of solids or semisolids.6.1.3 Test films 2.5 by 2.5 cm.NOTE 1A vehicle control for liquids is required because of thepotential for f

11、alse positives due to skin temperature changes whenhandling rabbits. Positive controls may be used to validate the test method.The use of 5 % procaine HCl as a positive control is suggested.36.2 The pH of the solutions should be measured andreported, if appropriate.7. Procedure7.1 Preparation of Tes

12、t Animals:7.1.1 Twenty-four hours before the test, clip the hair fromthe backs of the animals so as to expose two test areas on eachside of the spine, which are 10 cm apart.7.1.2 To obtain more effective contact between the skin andthe test substance, it may be necessary to use a non-irritatingdepil

13、atory agent. This test method may be used to ensure thatthe depilatory agent is non-irritating.7.1.3 Test sites may be designated as two on each side of thespine. Alternatively, the area may be divided into quadrantswith test and control substances applied to each quadrant.7.2 Test Procedure:1This p

14、ractice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Feb. 1, 2007. Published February 2007. Originallyapproved in 1981. Last previous editio

15、n approved in 2002 as F 719 81 (2002)e1.2For 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.3H. H. Draize, Apprai

16、sal of the Safety of Chemicals in Foods, Drugs, andCosmetics, 1965, p. 46.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.7.2.1 Wipe the exposed area of the back with alcohol.7.2.2 Using a sterile blade, abrade two of the four sites

17、bymoving the blade at right angles to the cutting surface in ascraping motion to create a denuded area of skin.Alternatively,make four epidermal incisions (which penetrate the stratumcorneum but not the dermis), with two perpendicular to theother two.7.2.3 Place the appropriate amount of the test ma

18、terial, asdescribed in 6.1, on one intact and one abraded or incised site.Place the control material on the other abraded and intact sites.7.2.4 Immediately occlude the sites by placing gauze flatson the test and control sites. Secure the patches with adhesivetape.7.2.5 Tightly wrap the animals trun

19、k with a clear polyeth-ylene sleeve.7.3 Test Site Examination and Scoring:7.3.1 Remove the polyethylene sleeve, gauze flats, test andcontrol materials, and any excess test or control liquids 24 hafter applying the test and control substances. Use alcoholsolutions for removing excess liquids.7.3.2 Us

20、ing the criteria of Table 1, score test sites forerythema and edema 1 h after removal.7.3.3 Rescore test sites for erythema and edema in accor-dance with Table 1 at 24 and 48 h after removal . Take care todistinguish test site erythema from minor skin temperaturechanges.NOTE 2There is a possibility

21、of infection associated with skinabrasion. Since infection would cause the same symptoms (erythema andedema) as would primary irritation, it is essential to ensure that thereaction is not due to infection. Any reaction at the control sites would bean indication of infection. If infection is suspecte

22、d, the test should berepeated with a new animal, and the test substance cultured.8. Interpretation and Calculation of Results8.1 Score abraded and intact test sites for erythema andedema in accordance with Table 1.8.2 The primary irritation index (PII) for each test animaland substance is the total

23、of the abraded (incised) and intactskin scores for erythema and edema at 1, 24, and 48 h afterremoval, divided by six. The average primary irritation index isequal to the sum of the PIIs for each substance for all testanimals divided by the number of test animals.9. Report9.1 The report should conta

24、in a description of the testmaterial, batch or lot number, vehicles, and extraction proce-dure used.9.2 Report the pH value of test solution and vehicle solutionif appropriate.9.3 Report test data for erythema and edema in accordancewith Fig. 1.10. Keywords10.1 acute toxicity tests; biocompatibility

25、; rabbits; skinirritation; test animalsTABLE 1 Scoring Criteria for Test ReactionsReaction Description ScoreErythema (ER) Erythema and EscharNo erythemaVery slight erythema (barely perceptible)01Well-defined erythema (pale red in color) 2Moderate to severe erythema (red and areawell defined)3Severe

26、erythema (beet redness to slight escharformation)4Edema (ED) Edema FormationNo edemaVery slight (barely perceptible)01Slight edema (edges of area well defined bydefinite raising)2Moderate edema (edges raised approximately1 mm)3Severe edema (raised more than 1 mm and ex-tending beyond area of exposur

27、e)4F 719 81 (2007)e12ASTM International takes no position respecting the validity 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 infringemen

28、t of such rights, are entirely their own responsibility.This standard is subject 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 f

29、or additional standardsand should be addressed to ASTM International Headquarters. 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 know

30、n to the ASTM Committee on Standards, at the address shown below.This standard 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).FIG. 1 Sample Report FormF 719 81 (2007)e13