ASTM_D_6355_-_07_2012.pdf

Designation:D635507(Reapproved 2012)Standard Test Method forHuman Repeat Insult Patch Testing of Medical Gloves1This standard is issued under the fixed designation D6355;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()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 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 determining 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 intensities 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 andtypically 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 denote 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 timewere 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 approximately 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(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 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 must 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 chemicals 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 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.Terminology2.1 Definitions:1This test method is under the jurisdiction of ASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Dec.1,2012.Published February 2013.Originallyapproved in 1998.Last previous edition approved in 2007 as D6355 07.DOI:10.1520/D6355-07R12.2Draize,J.H.,Woodward,G.,and Calvery,H.O.,“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 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,