{"operation":"document","citation":"98-0232","title":"Minntech Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1998-10-01","effective_on":null,"summary":"98-0232 response to Minntech Corporation concerning 173.136.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0232.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0232.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0232","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1998/980232.pdf","body":"<<<PAGE 1>>>\n\n•\n•\nU.S.Department\nof Transportation\nWashington, D.C.\n400 Seventh Street, S.W.\n20590\nResearch and\nAdministration\nSpecial Programs\nOCT\n/ 1998\nMr. Richard M. Ormsbee\nMinntech Corporation\nRef. No. 98-0232\n14605 28th Avenue North\nMinneapolis, MN\n55447\nDear Mr. Ormsbee:\nThis is in response to your letter of August 12, 1998,\non the determination of whether a\nmaterial meets the definition for a Class 8 (corrosive)\nmaterial under the Hazardous Materials Regulations (HMR; 49\nCFR parts 171-180). Specifically you ask whether you may use\nthe OECD guidelines (which require evaluation for 72 hours) to\ndetermine if a material is corrosive or if evaluation for 14\ndays is required to determine corrosivity for Packing Group II\nand III materials as provided by § 173.137. Your questions\nare paraphrased and answered as follows:\nl. Should the OECD guidelines be followed with the\nobservation time extended to 14 days regardless of whether the\nmaterial has shown full reversibility within a timespan of\nless than 14 days?\nA. The OECD guidelines were adopted in the HMR to provide the\nmethod to determine whether a material meets the criteria for\na Class 8 hazardous material. For purposes of classification\nunder the HMR evaluation of up to 14 days is required for\nClass 8 materials in Packing Groups II and III as provided by\nS 173.137. However, if a material causes full thickness\ndestruction of intact tissue in less than 14 days no further\nobservation is necessary.\n\n<<<PAGE 2>>>\n\n•\n•\nl. When classifying a material as corrosive or non-corrosive\n72 hours?\nis the OECD method acceptable with an endpoint observation of\nA.\nThe answer is no.\nFor classification purposes of the HMR\nobservation of up to 14 days is required.\nI hope this satisfies your request.\nSincerely,\nThomas I. Allan\nThomas G. Allan\nSenior Transportation Specialist\nOffice\nof Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\n*--AUG-12-98 WED 10:11 AM\nMINNTECH\nFAX NO. 6125533387\nP. 01/01\n.\"=\nLavalle\nMINNTECH\n$173.135\nMinntech Corporation\n14605 28th Avenue North\nMinneapolis, MN 55447 U.S.A,\n98-0232\nFAX\nCOVER SHEET\nDATE:\nTO:\nAugust 12, 1998\nEdward T. Mazzullo\nTIME:\nFAX:\n9:52 AM\n202-366-3012\n:\nFROM:\nRichard M. Ormsbee\nPHONE:\n612 551-2689\nFAX:\n612-553-3387\nRE:\nObservation times required for corrosivity testing\nCC:\nNumber of pages including cover sheet: 1\nMessage\nMr. Mazzullo,\nI would like to thank your office for the help that several people have provided me\nover the last couple of weeks. They have been very helpful in helping me\nunderstand several issues. I am writing you today to confirm that | properly\nunderstood the information that has been conveyed to me.\nOnce a material has been classified as a corrosive, a packing group must be\ndetermined using 49 CFR 173.137. In order to classify a material as Packing\nGroup Ill, one must follow the 1992 OECD Number 404 protocol but extend the\nobservation period beyond 72 hours as called out in the OECD protocol. The\nOECD Number 404 states \"Further observations may be needed to establish\nreversibility\"\n\", and the 49 CFR 173.137(c)(1) states \"That cause full thickness\ndestruction of intact skin within an observation period of up to 14 days..... Am I\ncorrect to understand that the DOT wishes the OECD protocol to be followed,\nextending the observation times to 14 days regardless of whether a certain\nmaterial has shown full reversibility within a timespan of less than 14 days?\nMy next question has to do with (1997) 49 CFR 173.136 Class 8 - Definitions.\nWhen classifying a material as corrosive or non-corrosive, the 1992 OECD\nGuideline for Testing of Chemicals, Number 404 is acceptable with an endpoint\nobservation time of 72 hours?\nThank you for taking the time to answer and clarify these issues.\nSincerely,\n/Richard M. Ormsbee\n•\n...\n•...\n\n<<<PAGE 4>>>\n\n3Eu-14-90\n1.2/14/83\n10:30\nFROM:\nSWIDLER % BERL1I\nPAGE\nAdopied:\n17.07.92\nDECD GUIDELINE FOR TESTING OF CHEMICALS\nAdopted by the Council on 17° July 1992\n•\nAcure Permal Irritation/Corrosion\nINTROPUCTION\nrogress. In the revlew, special amention is given to possible improvements in reladon to anim\n• OECD Guidelines for Testing of Chemicals are periodically revlewed in lighs of scienun\n•\nmeeting of OECD expens held in Paris in May 1991.\nwelfare. This updated version of the original guideline 404 (adopied in 1981) is the outcome of a\n2.\ninclusion of data from in vito tests in the information on which a decision not to pracced to an in vivo\nThe main differences between this and the original version of the guideline are: 1) the\nrest can be based; and b) the possibility to use one animal in a firsi step of the in vivo procedure\nallowing corain chemicals to be exempled fium furior lesling.\n3. Definidions used are set our in the Annex.\nINITIAL CONSIDERATIONS\navoided, and that any testing which is likely to produce severe responses in animals is minimised\nIn the interests of animal welfare, il is important thas the unnecessary use of animals is\ndermal irritation/corrosion:\nConsequently, lest materials meeting any of the following criteria should nos be lested in anlmals for\n1)\nmaterials that have predictable corrosive potental. based on structure-sctivity\ne.g.. when the material to be applied has a pri of 2 or less or 11.5 or greater (alkaline\nrelationships and/or physicochemicai properties such as sirong acidity or alkalinisy,\n-\nOr acidie reserve (1) should also be teken into account):\nmaterials which have been shown to be highly roxic by the dermal rouce:\n11I)\nmaterials which, in an acure dermal toxicity test (2), have been shown not to produce\nirritation of the skin at the limit zest dose level of 2000 maky body weight\npredicted on the basis of results from in vitro rests (3).\nIn addition, It may not be necessary lo test la vivo materials for which corrosive properties are\n-\n• -.\nPRINCIPLE OF THE IN VIVO TEST\nanimes, untreaied skin areas of ine lest animals) serving 2s control. The desree of imitation is read\nThe substance to be lested is appled in a single dose to the skin of one or more experiment\n:\n1/6\n-\n\n<<<PAGE 5>>>\n\n12454\nDali In UNDU -\nULDSTOLCI\n...\nand scored at specified intervals and is further described in order to provide a complete evaluation of\nthe effects. The duradon of the study should be sufficlent to evaluate fully the reversibility of the\neffects observed.. Animals showing severe distress andor pain al any siage of the rest must be\nhumanely killed.\nDESCRIPTION OF THE IN VIVO METHOD\nSelection eL animal species\n6. Several mammalian species may be used. The altino rabbit ls the preferred species.\nNumber and sex of animal\ncan be used. Additional animals may be used to clarity equivocal resporses. Somelimes the zest can\nThree healthy adult animais are required for the complete test Male endor female enimals\nbe performed with are animal only.\nHousine and feedine sonditions\nshould be 20°C (+ 3°C) for rabblis, 22°C (+ 3°C) for rodents and the relauve humidity 30 10 70 per\nAnimals should be individually housed. The temperature of the experimental animel room\"\ncent. Where the lighting is ardificial, the sequence should be 12 hours leh, 12 hours dark\nConventional laboraiory diers are sultable for feeding and an unrerricied supply of drinking wates\nshowd be available.\nPreparation of the enimals\n9.\narea of the trunk of the animals. Cart should be taken to avoid abrading the skin and only animals\nApproximarely 24 hours before the test, fur should be removed by close-clipping the dorsal\nwith healthy intact skin should be used.\n10.\nSome strains of rabbit have dense parches of hair which are more prominens al certain times\nof the year. Such areas of dense hair growth should not be used as patch sites.\nPROCEDURE\n•\nApplisation of the test substance\nThe test substance should be applled to a small area (approximately 6 cm?) of skin and coyerod\nwith a gauze patch, which is heid in place with non-imating tape. In the case of liquids or some\npastes, it may be necessary so apply the test subslance to the gauze patch and then apply that to the\nskin. The parch should be loozely held in contacs with the skin by means of a suitable semi-occlusive\ndressing fos the durazion of the exposure period. Access by the animal io the parch and resultant\ningestion/inhalation of the rest subscence should be prevensed\n12.\nLiquid test substances are generally used undiluled. When testing solids (which may be\npulverised if considered necessary), the less subsiänce should be moistened with the smallest amount\nof waser, or where necessary & fuitable vehicle, needed to ensure good contact with the skin. When\nvenicles are used, the influence of the vehicle on Immation of the skin by the test substance should be\ntaken into account.\n13. At the end of the exposure period, normally & hours, residual sess substance should be\n2/6\n-\n\n<<<PAGE 6>>>\n\n12/14/8315:22\nremoved, where practicable, wing waler or an appropriale solvent without ellering the exiting\nresponse or the integrity of the epidermis.\nDose level\n14. A dose of 0.5 mi of liquid or 0.5 g of solid or semi-solld is applied to the test site.\nExpertie of one animal\n15.\nIl it is suspected that the sest substance mizhi produce severe irritancy/corrosion, & single\nrest parches are applied simulianeously so the animal. Ine first parch is removed after three minutes.\nanimal rest should be employed. When it is suspected that the substance may cause corrosion, three\nIf no serious skin resction is observed, the second patch in removed after one hour. If the observatons\nIs removed after four hours and the responses are graded. I! & corrosive effect is observed after elther\nal Lais slage indicate that exposure ear humanely Do allowed to exend to four hows, the third parch\nthree minutes or one hour exposure, the lest is immediaiely terminated by removal of the remaining\npatches. Altematively, the three patches may be applied sequendaily. When it is suspecied whar the\nsubstance may cause severe imitancy, & single paich should be applied to the animal for four hours.\n•.\nExposure ele further twe animals\n16.\nIf neither a corrosive effect nor a severe imiant effect is observed after a four hour exposure,\nperiod of four hours.\nthe test should be complered wins two addional animals, cach with one parch only, for ar exposure\nExpósure of shree animals\n17.\nmay be site expected animals, due rect in one pace for an exposure or or our hone\nQbservation period\n18. The duraton of the obseryation perted thould not be fixed rigidly bur should be sumcient is\nevaluate fully the reversibility of the effocts observed.\nSunleal observations and stadine of skin reastions\n19. Animals should be examined for signs of erythema and oedema and the responses scored ai\nrecorded and fully described.\n3/6\n\n<<<PAGE 7>>>\n\n12/14/83.15:22\nTABLE: GRARING OF SKIN REACTION\nErythema and Eschar Fermation\nNo erythema\nWell defined erytema\nVery slight erytherna (barely percepuble)\nModerate lo severe erythema\n2\nSovere erythema (occi redness) to eschar formaton\n3\nprevenuing grading of erythama.\n4\nMeximum possible: 4\nSedema Formatien\n:..\nNo oedema\nVery slight oedema (oarely percepuble)\n..•\n0\nModerate oedema (raised approximately 1 mllimetre)\nSlight ocdera (edges of trea well defined by definite raising)\n..•\n2\nSevere oedema (raised more than 1 millimert\n3\nand extending beyond area of exposure)\n....\n...\nMaximum possible: 4\nHistopathologicel examination may be carried our to clarily doubtful reactions.\nDATA AND REPORTING\nPass\n20. Data should be summarised in lbular form, showing for cach individual animal the irritation\nscores for erythema and ocdera al 60 minutes, 24,48 and 72 hours after paich removal, all lesions.\na description of the dogree and nature of irrilation, corrosion or reversibllity, and any orber toxic\neffects observed.\nIntreport\n21. The rest repor must include the following infomation:\nTess substance:\nidentification dace\nphysical nature and, where relevant, physicochemical properties:\nVehicle:\n• jusufication for choice of vehicle.\nTess animais:\n•\n: species, al and der\n•\nnumber, age and sex of animals:\n4/6\n-\n\n<<<PAGE 8>>>\n\n12/14i\nzaui iso yuou\n...•\n?.-\n• .\nspare a use gond is diat he star and at the concludio of the lost.\nTest conditions:\n-\n:\ntechnique of patch sise proparation;\ndetails of parch materials used and parching rechnique:\n• decalls of last rubslence preparation, application and removal.\nResules:\n-\ntabulation of inication response data for cach individual animal for each\nreMOYal);\nobservation time perlod (c.8. 60 minures, 24, 48 and 72 hours after parch\n• description of all lesions observed;\nsarrive descripzion of the degree and nature of imriation observed, and any\nhistopachological findings;\ndescription of any other toxic effects in addition to dermal Iration/corrosion.\n•\nDiscussion of the results.\nincluding details of the procedure, must be given together with results oblained with the tess and\nIl an in vitro sest is performed before the in vivo rest, the description or referencs of the resh\nreference substances.\nLITERATURE\n(1)\nYoung J.R., How M.J., Walker A.P. and Wonh W.M.H. (1988). Classification as corrosive\nor irritant to skin of preparations cantalning acidic or alkaline substances withour testing on\nanimals. Toxicology in Viro, 2. 19-26.\n(2)\nOECD, Parts (1987). Guideline 402.\n(3)\n:\nECETOC Monograph No. 15, \"Skin Imation\", European Chemical Industry, Ecology and\nToxicology Centre, Brussels, July, 1990.\n5/6\n\n<<<PAGE 9>>>\n\nDEC - 14-93\n14-1431: 32. FROM:\nUSE BERLIN\nE0zMYD: 2024247643\n....PAGE\n-\nANNEX\nDEFINITIONS\nDermal irication is the producion of reversible infammatory changes in the skin following the\napplicadon of a les: subrance.\nD me corgin l the produston of inevertlic listue danage In the skia following the application.\n.:.-.\n6/6","truncated":false,"body_characters":13694}