ASTM_F_2147_-_01_2010.pdf

Designation:F214701(Reapproved 2010)Standard Practice forGuinea Pig:Split Adjuvant and Closed Patch Testing forContact Allergens1This standard is issued under the fixed designation F2147;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 practice is intended to determine the potential for asubstance,or material extract,to elicit contact dermal allerge-nicity.1.2 This practice is intended as an alternative to the GuineaPig Maximization Test(GPMT),given the limitations ondosage form and tendency for false positives associated withthe latter test.See Rationale and References.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F619 Practice for Extraction of Medical PlasticsF720 Practice for Testing Guinea Pigs for ContactAllergens:Guinea Pig Maximization Test2.2 ISO Document:ISO 10993-10,1995 Tests for Irritation and Sensitization33.Terminology3.1 Definitions:3.1.1 2,4 dinitrochlorobenzene(DNCB)strong sensitizer,used as a positive control.3.1.2 Freunds Complete Adjuvant(FCA)a commercially-available mixture of oil and Mycobacterium that is known toelicit an immune response.3.1.3 Guinea Pig Maximization Test(GPMT)proceduredescribed in Practice F720 accepted as a“worst case”assay forallergenic potential.4.Summary of Practice4.1 The split adjuvant method is used when topical appli-cation is considered relevant,and the dosage form is a solid,liquid,extract,paste,or gel.The method includes four induc-tion doses applied over ten days to the same shaved ordepilated site on guinea pigs,followed by occlusive patching.Freunds Complete Adjuvant(FCA)is injected near the dosesite on the fourth day(second induction dose).Following a restperiod,animals are challenged at a previously unexposed site,and the reaction evaluated at 24,48,and 72 h.4.2 The closed patch method is used when topical applica-tion is relevant,but the preferred dosage form does not permitinjection under the skin or intradermally,and the discomfortinvolved with extended occlusive patching and adjuvant use isto be avoided.It involves repeated induction doses(3 to 6)over14 days at the same shaved/depilated site,followed each timeby 6 h of occlusive wrapping.After a rest period,animals arechallenged at previously untreated sites,and their reactionsevaluated at least 24 and 48 h later.5.Significance and Use5.1 In selecting a material for human contact in medicalapplications,it is important to ensure the material will notstimulate the immune system to produce an allergic reactionunder relevant exposure conditions.Extractable chemicalsproduced by skin contact or during physiological exposuresmay cause allergic reactions.Therefore,this practice providesfor evaluations of solid or semisolid dosage forms usingmaterial extracts or direct evaluation of the test article.Therationale for this animal model is based on the fact that theguinea pig has been shown to be an appropriate animal modelfor predicting human contact dermatitis;its tractable nature,itsavailability from reputable suppliers,the historical database of1This practice 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 Sept.1,2010.Published November 2010.Originallyapproved in 2001.Last previous edition approved in 2006 as F2147 01(2006).DOI:10.1520/F2147-01R10.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 information already acquired using this species,and the corre-lation of such results to data on known human allergens,allcontribute to its widespread use for allergenicity studies(1-5).45.2 The need for sensitization procedures other than themaximization test(Practice F720)is based on:(1)the need fora route of exposure more similar to use conditions,(2)concernover the use of adjuvant because of its recruitment of cell typesto the test site which are not typically involved in immunologicreactions,and bec