{"operation":"document","citation":"13-0073","title":"Aceto Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2013-07-23","effective_on":null,"summary":"13-0073 response to Aceto Corporation concerning 173.132, 173.133, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0073.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0073.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0073","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2013/130073.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave, S.E.\nWashington, D.C. 20590\nJUL 2 3 2013\nMs. Suhey Francisco\nSr. Regulatory Affairs Specialist\nAceto Corporation\n4 Tri Harbor Court\nPort Washington, NY 11050\nRef. No.: 13-0073\nDear Ms. Francisco:\nThis is in response to your March 12, 2013 email requesting clarification on acute toxicity\ntest requirements for inhalation toxicity in the Hazardous Materials Regulations (HMR; 49\nCFR Parts 171-180).\nAccording to the information in\nyo~r letter, you have classified your material Methylene-\nhis( 4-cyclohexylisocyanate) or synonym Cyclohexane, 1,1 '-methylenebis[ 4-isocyanato-\n(CAS# 5124-30-1) using publicly available test data as UN2206, Isocyanates, toxic, n.o.s.,\n6.1, PG II. The acute toxicity test data values used in your classification are as follows:\nLC5o Rat (male, head only exposure to an aerosol) inhalation 0.295 mg/L/4hr\nLC5o Rat (female, head only exposure to an aerosol) inhalation 0.307 mg/L/4hr\nAfter adjusting the four-hour exposure data in accordance with§ 173.132(b )(3)(i) you\nindicate the one-hour exposure results as LC50 Rat (male) 1.18 mg/L/1hr and LC50 Rat\n(female) 1.228 mg/L/lhr. In accordance with the§ 173.133(a)(l) table, this material is\nassigned to packing group II.\nSpecifically, you seek clarification on the suitability of test result data as the exposure was\nto an aero so 1 and not to either a dust or mist as prescribed in § § 1 73 .13 2 and 1 73 .13 3 and if\nthese results should be applied when classifying your material.\nThe answer to your question is yes. The test results would be applicable when exposure is\nadministered as a liquid aerosol that emerges as a mist, if a mist is likely to be generated in a\nleakage of the transport containment as prescribed in§ 173.132(b)(3)(iii). As provided in\n§ 173.22, it is the shipper's responsibility to make this determination.\nIn addition, you also request clarification that if the aforementioned test method 1s not\nappropriate for determining the toxicity of the material, would it still require classification as\nUN2206, Isocyanates, toxic, n.o.s., Class 6.1, because of its chemical family.\n\n<<<PAGE 2>>>\n\nUnder§ 173.22 of the HMR it is a shipper's responsibility to properly classify a hazardous\nmaterial. A poisonous material (liquid) is defined in§ 173.132 as a material, other than a\ngas, which is presumed to be toxic to humans because it falls within one of the following\ncategories when tested on laboratory animals: oral toxicity, dermal toxicity and inhalation\ntoxicity. If your material meets the LC:;o or LD50 criteria for any of these categories, it meets\nthe definition of a Division 6.1 material. Thus, if your material meets the definition of a\nDivision 6.1, or any other hazard class, then it must be classified accordingly, an.i the\ndetermination should not be based solely on its chemical family.\nI hope this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nV1/\nDelmer Billings\nSenior Regulatory Advisor\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nAceto Corporation\n4 Tri Harbor Court\nPort Washington, NY 11050\nTel: (516) 627 6000\nFax: (516) 627 6093\nwww.aceto.com\nU.S. Department of Transportation\nOffice of Hazardous Materials Standards Pipeline\nand Hazardous Materials Safety Administration\n1200 New Jersey Avenue, SE\nWashington, DC 20590-0001\nMarch 8, 2013\nRe: Interpretation of test data values for LC50 inhalation rat in accordance to 49 CFR § 173 .132(b)(3).\nDear Sir or Madam:\nAceto Corporation is requesting from the Associate Administrator for Hazardous Materials\nSafety a clarification on the test result requirements for LC50 toxicity data values for\ninhalation rat\nUsing publically available test data, we have classified our material Cyclohexane, 11 '-\nMethylenebis(4-isocyanato- [CAS# 5124-30-1 J as UN2206, Isocyanates, toxic, n.o.s., Class 6.1,\nPG ll. However, it has come to our attention that because of the method of testing, this material\nmay not be subject to the classification. The test data values we have are the following:\nLC50 Rat (male, head only exposure to an aerosol) inhalation 0.295 mg/LI4hr\nLC50 Rat (female, head only exposure to an aerosol) inhalation 0.307 mg/L/4hr\nOnce the test data has been adjusted in accordance with 49 CFR § 173 .132(b )(3)(i), the test data are LC50\nInhalation Rat l. 18 mg/L/1 hr and LC50 1.228 mg/L/1 hr respectively. This would place the material as\npackaging group I L However, due to the exposure as an aerosol and not a dust/mist as specified in the\nregulations, some sources have argued that this would exempt the material from its hazardous\nclassification. Does the test method of exposure as an aerosol affect the toxic classification of the\nmaterial?\nfurther to that, Aceto has classified the material as an isocyanate, which is specifically listed in the\nhazardous materials table. If the test method is not appropriate for determining toxicity of the material,\n\n<<<PAGE 4>>>\n\nwouldn't it still require classification as UN2206, Isocyanates, toxic, n.o.s. because of its chemical\nfamily?\nAceto appreciates your attentiveness to this matter and looks forward to your Jesponse. If you have any\nquestions or concerns, please feel free to contact me by phone at 5 I 6-627-6000, ext 596 OJ by email at\nsfranciscoUiJaceto.com.\nSincerely,\n\\\nSuhey Francisco\nSr. Regulatory Affairs Specialist\nAceto Corporation","truncated":false,"body_characters":5465}