ASTM D6355-2007 809 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves《医用手套使人体再现过敏斑点的测试用标准试验方法》.pdf

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1、Designation: D 6355 07Standard Test Method forHuman Repeat Insult Patch Testing of Medical Gloves1This standard is issued under the fixed designation D 6355; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision

2、. 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 evaluate the potential ofglove materials under test to induce and elicit Type IV skinsensitization

3、 reactions (that is, allergic contact dermatitis) inhumans.1.2 This test method should be used by individuals experi-enced in or under the supervision of those experienced in theuse of good clinical practice procedures.1.3 During the performance of the Human Repeat InsultPatch Test (RIPT) for determ

4、ining sensitization, investigatorsare confronted with skin responses that represent skin irritation(non-immunologic responses) or allergic contact dermatitis(ACD). The numerical scoring system for grading the intensityof both are similar and test facilities may vary in their scoresthat describe inte

5、nsities of allergic and irritant skin responses.The hallmark of a mild allergic contact dermatitis is a sustainedpalpable erythematous reaction. Delayed-type allergic contactreactions from patch tests have intensity characteristics thatfavor scores of higher values for longer periods of time andtypi

6、cally do not produce a minimal score (score of 1, ajust-perceptible erythema) for short durations (less than 48 h).It is the responsibility of the investigator to evaluate the scoresin light of irritant reactions so that the responses are allergic innature and not irritant. The investigator should d

7、enote a finalscore as either due to contact allergy or irritation. Paragraphs9.5-9.5.5 describe a commonly used scoring system anddiscuss allergic and irritant responses in detail.1.4 The Draize RIPT was published in 1944 as an attempt todecrease the frequency ACD.2The test techniques at that timewe

8、re just being validated and this experimental design waslargely empiric.3The principle of the test is as follows:1.4.1 Multiple inductions of the study material at relativelynon or low irritancy levels,1.4.2 Approximately a two-week rest period, and1.4.3 Astandard diagnostic challenge of approximate

9、ly 48 hand a delayed reading at approximately 96 h after patchapplication.1.5 In the intervening years, with further experimentationadded to this empiric approach, three additional principles havebeen learned:1.5.1 Increasing the concentration of the study material,1.5.2 Defining a no effect level (

10、this is possible with onlyindividual ingredients and not the final study material), and1.5.3 The enhanced sensitivity and the use of occlusion(where occlusion would not ordinarily be present).1.6 In 1945, Henderson and Riley4demonstrated that a testpanel sample size of 30 000 subjects would have to

11、beemployed to ensure statistically that there would be no morethan 0.1 % sensitization. If there are no allergic responses in atest panel of 200 subjects with exposures comparable to thoseof the population, then there could be as many as 1.5 allergicreactions per 100 users.1.7 All medical devices mu

12、st be safe and effective for theirintended use. Since medical devices such as gloves come incontact with human tissue, they should be tested for biocom-patibility in animals first. The human repeat insult patch test(RIPT) is one test that can be used to test rubber gloves for skinsensitization to ch

13、emicals used in the manufacture of gloves.1.7.1 Since various forms of the RIPT exist, a singlestandardized test method that outlines the testing protocol,scoring system, and the criteria for skin sensitization should bedeveloped.1.8 This standard does not purport to address all of thesafety concern

14、s, 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. Terminology2.1 Definitions:1This test method is under the jurisdiction of ASTM Com

15、mittee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Nov. 1, 2007. Published December 2007. Originallyapproved in 1998. Last previous edition approved in 2003 as D 6355 98 (2003).2Draize, J.H., Woodward, G., and Calvery, H.O.

16、, “Methods for the Study ofIrritation and Toxicity of Substances Applied Topically to the Skin and MucousMembranes,” Journal of Pharmacology and Experimental Therapeutics, Vol 83,1944, pp. 377-390.3Shelanski, H. A., and Shelanski, M. V., “A New Technique of Human PatchTest,” Proc. Sci. Sect. Toilet

17、Goods Assoc. , Vol 19, 1953, pp. 46-49.4Henderson, C. R., and Riley, E. C., “Certain Statistical Considerations in PatchTesting,” Journal of Investigative Dermatology , Vol 6, 1945, pp. 227-232.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, Unite

18、d States.2.1.1 allergen, na substance capable of causing an aller-gic reaction.2.1.2 allergic contact dermatitis (ACD), na Type IVdelayed-in-time dermatitis that is caused by skin contact witha hapten that evokes a cell-mediated (delayed-type hyersensi-tivity) immune response.2.1.3 allergic contact

19、dermatitis reaction, nan adverseimmune response following exposure to chemical (non-protein) allergens.2.1.4 antigen, nany substance that provokes an immuneresponse when introduced into the body.2.1.5 atopic dermatitis, nthe most common form ofchronic inflammatory dermatitis.2.1.5.1 DiscussionAlthou

20、gh immunologic mechanismsmay play a role in producing this dermatitis, the role of anyallergen in producing and sustaining this morphologicallysimilar dermatitis is not proven or as clearly understood asclassical allergic contact dermatitis.2.1.6 blister, na vesicle containing serum.2.1.7 bullae, ns

21、ynonymous with blister.2.1.8 cell-mediated immunity, nthat portion of the im-mune system mediated by white blood cells called T-cells orT-lymphocytes.2.1.9 challenge test, na medical procedure used to iden-tify a substance to which a person is sensitive by deliberatelyre-exposing them to that substa

22、nce in an attempt to reproducethe reaction.2.1.10 dermatitis, ninflammation of the skin evidenced byitching, redness, and various skin lesions.2.1.11 diagnostic patch tests, na form of skin testing inwhich suspected allergens are applied to the skin, covered, andobserved 48 to 96 h or more later to

23、see if a reaction occurs.2.1.11.1 DiscussionThis test is often used to identifypossible causes of allergic contact dermatitis.2.1.12 eczema, nsynonymous with dermatitis.2.1.13 edema, nswelling caused by excessive infiltrationof fluid into the skin.2.1.14 erythema, nsynonymous with redness of the ski

24、n.2.1.15 immune response, nthe activity of specialized cellsor their products against antigens and allergens introduced tothe body.2.1.16 immunize, vto render a patient immune from for-eign substances.2.1.17 induration, nhardening of a tissue due to edemaand cellular infiltration.2.1.18 inflammation

25、, na basic response of the body toinjury, usually characterized by redness of the skin, warmth,swelling, and pain.2.1.19 irritation, na chemically induced dermatosis with-out immunological involvement.2.1.20 mast cells, ntissue cells that contain packets ofbiochemicals responsible for the symptoms o

26、f allergy.2.1.20.1 DiscussionWhen allergens attach to IgE antibod-ies sitting on the surface of these cells, a signal is sent, causingthem to release these biochemical mediators of allergy.2.1.21 mediators, nsoluble products of immune cells thatinteract and/or activate other parts of the immune syst

27、em.2.1.22 mild irritant control, na substance that will pro-duce a minimally perceptible dermatitis.2.1.23 neutral control, na substance, such as water, thatthrough clinical usage, has not been found to be an allergen.2.1.24 papules, nsmall, solid red elevations of the skin.2.1.25 predictive patch t

28、est, na repeat insult patch test(RIPT) used as a toxicology test to determine the potential forACD.2.1.26 sensitive, vto expose to an antigen, provoking animmune response so that on re-exposure to that antigen, a moreadvanced secondary response occurs. Synonymous with im-munize.2.1.27 study material

29、, na synthetic or natural polymermaterial used as a medical glove or as a part of a medicalglove.2.1.28 vesicles, nsmall circumscribed fluid-filled eleva-tions of the skin smaller than a blister.3. Summary of Test Method3.1 A general medical history of the study subjects shouldbe taken and include i

30、nformation on dermatologic conditionsand sensitivities to specific compounds. Studies conducted inaccordance with this human RIPT protocol will employ aminimum of 200 study subjects. Prior to evaluating thematerial in a human RIPT, acceptable toxicology data shouldbe obtained. The sensitization pote

31、ntial of the study material isevaluated in a test panel of a minimum group size of 200subjects. The study panel should include men and women. Theinduction phase of the human RIPT includes 10 multiple 48-h(72-h on weekends) patches at the same site typically on theupper back with no rest between repa

32、tching except for scoring.The patch site is graded for skin responses prior to eachsubsequent patch application. In the event of any significanterythema, the site of patch application should be moved toanother location to confirm the reaction. Following the comple-tion of the induction phase, there

33、is approximately a 21 day restperiod to allow the development of latent sensitization. This isfollowed by two consecutive 48-h challenge patches applied tonaive sites. Responses are evaluated after the removal of eachconsecutive 48-h patch application.Aminimum of two delayedskin site gradings is req

34、uired to differentiate irritation fromsensitization reactions. If the results are equivocal, a secondchallenge, after the original challenge dermatitis has cleared,may be conducted to ensure that sensitization was not over-looked.4. Significance and Use4.1 This RIPT method assesses the potential of

35、skin sensi-tization with a particular medical product by repeated topicalapplications to the skin of selected subjects. This is a procedurethat has the potential to detect many, but not all, sensitzers.This requires multiple applications to induce a cell-mediatedType IV immune response sufficient to

36、 cause an allergicreaction.4.2 In general, the sensitization procedure requires 10 mul-tiple 48-h (72-h on weekends) applications of patches contain-ing the study material over a three-week induction phase.Induction is followed by approximately a 21 day rest phase toallow the development of any late

37、nt sensitization. StudyD 6355 072subjects are then challenged by the application of two consecu-tive 48-h patches of the study material to naive sites. Re-sponses are evaluated and graded after the removal of eachconsecutive 48-h patch application.4.3 Although this test method is a clinical method,

38、it may beused as part of a risk analysis to determine the potential forType IV allergic contact dermatitis.4.4 This test method assumes that good clinical practiceswill be utilized, including adequate training of practitioners.5. Interferences and Precautions5.1 During the course of the study, the a

39、rea of the studysubjects where the patch is applied should not be bathed,showered, or washed. The patch area must stay dry. Wetpatches can be a source of mild irritation reactions.5.2 Caution: Patch testing can involve a certain risk to thesubject due to sensitization or raising of the level of sens

40、itivityto the study material.6. Experimental Plan6.1 Subject Inclusion/Selection Criteria6.1.1 Subjects ranging from 18 to 65 years.6.1.2 Subjects who complete a medical/personal historyform.6.1.3 Subjects who have read, understood, and signed aninformed consent agreement.6.1.4 Subjects should inclu

41、de both male and female.6.2 Subject Exclusion/Rejection Criteria6.2.1 Subjects with skin disease that, in the opinion of theinvestigator, could interfere with the evaluation.6.2.2 Subjects taking medications that, in the opinion of theinvestigator, would interfere with the study.6.2.3 Subjects with

42、clinically significant psoriasis, eczema,or atopic dermatitis.6.2.4 Subjects who are pregnant or become pregnant duringthe study.6.2.5 Subjects with known sensitivity to natural rubber andrubber chemicals.6.2.6 Subjects who have acquired a recent marked skintanning or sunburn that, in the opinion of

43、 the investigator,would interfere with the study.6.2.7 Subjects who have undergone any type of sensitizationtesting within the last thirty days.6.2.8 Subjects who are lactating women.6.2.9 Subjects exogenously or endogenously immunosup-pressed.6.3 Study Group6.3.1 Sample Size:6.3.1.1 A minimum of 20

44、0 subjects will complete the study.6.3.2 Clinical Sites:6.3.2.1 One clinical location with a minimum total samplesize of 200 subjects.6.3.2.2 The testing may be done in a single clinical locationbut avoiding extreme climatic conditions.7. Institutional Review and Informed Consent7.1 Institutional Re

45、view:7.1.1 The method for this study should be reviewed by anappropriate Institutional Review Board (IRB).7.2 Informed Consent:7.2.1 An informed consent document should be obtainedfrom each study subject prior to initiating the study.8. Study Materials and Patch8.1 The patch will be an adhesive band

46、age witha2by2-cmor larger Webril pad (or equivalent) affixed.8.2 All study materials should be applied in an amountproportionate to the size of the 2 by 2-cm or larger patch.8.3 ANeutral Control patch will be a adhesive bandage witha 2 by 2-cm or larger Webril pad (or equivalent) wetted with0.2 mL o

47、f distilled or deionized water.8.4 The study glove material should be applied so that theinside glove surface is exposed to the skin of the test subject.9. Study Design9.1 The human RIPT is performed to determine the poten-tial of the product for sensitization under conditions relative toanticipated

48、 consumer exposure.9.2 Patch Site:9.2.1 Patches should be applied to the upper back area,either to the right or left of the midline. (The arm may be usedas an alternative patch site to the back area.)9.2.2 The upper back, either to the right or left of themidline, is the most common site used for pa

49、tch testing. Thisarea has been preferred because of its larger, more uniformsurface; it is more accommodating to multiple tests. For manyvolunteer subjects, testing at this site is less obtrusive. How-ever, there are occasions when the upper arm or forearm maybe the preferred site. There is no data that supports thesuperiority of one of these skin sites over another for inducingexperimental sensitization.9.3 Study Description:9.3.1 Induction Phase:9.3.1.1 The induction phase of the RIPT includes 10 mul-tiple 48-h (72-h on weekends) patches at a single sit