99-0240
99-0240
Page 115. Departmer f Transportation Washington, D.C. 400 Seventh Street. S.W. 20590 Research and Idministratior pecial Program: APR 2 0 2000 Mr. Valois Pagan III Consultant Reference No. 99-0240 Dangerous Goods of America, Inc. P.O. Box 590888 Miami, FL 33159-0888 Dear Mr. Pagan: This is in response to your letter concerning what types of laboratory animals are acceptable for determining the oral and dermal toxicity and packing group for a Division 6.1 material under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). I have paraphrased your questions and answered them in the order provided. Q1. Section 173.132 states that the toxicity test is to be performed on "albino rats." If a material safety data sheet (MSDS) for a product shows that the tests were performed on rats, mice, or rabbits, may this information be used to determine the Packing Group? A1. Typically, when a toxicity test is performed requiring the use of albino rats, a laboratory performs the test on albino rats but states for convenience that the test was performed on "rats" in its literature for public distribution describing the resulting classification. A description of the types of rats used can usually be found in the laboratory's hazard classification test report on the material. If the obtain additional information. report does not contain this information, you should consult the laboratory staff to We do not accept toxicity tests performed on mice. A material that meets one or lore of the LDso or LCso criteria for oral, dermal, or inhalation toxicity as a resu f testing in accordance with $ 173.132 meets the definition of a poisonou material (Division 6.1). As stated in § 173.132(b), albino rabbits are to be used to test for dermal toxicity and albino rats are to be used for oral or inhalation toxicity. Animal test data that has been reported in chemical literature should be used whenever possible. Under § 173.133, the shipper assigns the material a Packing Group based on these results. 990240#
Page 2An MSDS for a product shows that the toxicity tests were performed on rats, but not specifically "albino rats," and rabbits. If the rat specimen test results show the product is not regulated but the rabbit specimen test results show the product is a Division 6.1, Packing Group III material, is this product regulated under the HMR? Why? A2. See our response in Al. I hope this satisfies your request. Sincerely, Hotter. Mitchelp Hattie L. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards 2#
Page 3DANGEROUS GOODS OF AMERICA, INC. PO BOX 590888 + MIAMI, FL 33159-0888 • USA -MAIL: info@dangerousgoods.net + WEB SITE: www.dangerousgoods.ne Phone (305) 871-3313 • Fax (305) 871-138 Mr. Edward Mazzulo Department of Transportation Mack §173,132 99-0240 August 19, 1999 Dear Mr. Mazzulo, 6.1 Toxic substances, more specifically, oral and dermal toxicity. Below I have asked two questions in reference to packing group criteria with respect to Division Q: Subpart 173.132 of CFR-49 states that the LDso toxicity tests are performed on "albino rats". If an MSDS shows only information for other rodents like rats, mice and/or rabbits, and not Groups? specifically "albino rats", can this information be used to determine respective Packing Q2: Subpart 173.132 of CFR-49 states that the LDso toxicity tests are performed on "albino rats". If an MSDS shows the toxicity tests results for two rodents, a rat and a rabbit, not is not regulated, according to the information given on the rabbit (for the same substance) specitically stating "albino rat", according to the information given for the rat, the substance why not? the substance would be considered Packing Group I!!, is this product regulated? Why or Please respond in writing to: Mr. Val Pagan Dangerous Goods of America PO Box 590888 Miami, FL 33159 Please do not hesitate to contact our office should you have any questions. Best regards, Consultant OFFICE & WAREHOUSE FACILITIES • 1651 NW 68'" AVE • CARGO BLDG 706 • SUTE 213#
This material provides agency context. It does not replace binding regulatory text, and its legal effect depends on the underlying authority and facts.