Musashino Chemical Laboratory, — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Research and Special Programs OCT 23 1998 Administration Mr. Yukawa Muneaki Technical Department Manager Ref. No. 98-0240 Musashino Chemical Laboratory, Itd. Yaesu-Daibiru Bldg. 1-1, Kyobashi I-Chome, Chuo-Ku Tokyo 104 Japan 0031 Deax Mr. Muneaki: This is in response to your letter dated August 18, 1998, regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to lactic acid and its derivatives. material as defined in the HMR. Specifically, you ask if lactic acid is a class 8 understanding that lactic acid is You also state that it is your dermal irritation/corrosion classification contained in the 1992 a class 8 material based on the Guideline for Testing of Chemicals. Organization for Economic Cooperation and Development (OECD) Under § 173.136 of the HMR, class 8 materials are liquids or solids that cause full and irreversible thickness destruction of human skin at the site of contact within a specified period of A liquid that has a severe corrosion rate on steel or aluminum based on the criteria in § 173.137 (c) (2) is also a corrosive material. after A packing group is evaluating data obtained from testing conducted in assigned to the material accordance with OECD Guidelines, and then determined from the criteria specified in § 173.137. If your material has been tested for skin corrosion using a previously authorized test method there is no need to retest it. If you choose to have your and found to be not corrosive, material retested, however, and it meets, for example, class 8, packing group Ill, a proper shipping name then must be selected Irom the generic or n.o.s. descriptions corresponding to the specific hazard class and packing group for the material and it applicable requirements. must be offered for transportation in accordance with the .-#

Page 2I hope this satisfies your inquixy. Also, I have enclosed some • informational material. further assistance. Please contact us if we can be of Sincerely, Hatte z. Mitchell Hattie I. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 30598-8-18:10:11 AM: 206 (# ;03 3275 2206 11 2DHM 98-0248 TELEX: 2222235 LACHEMS TELEPHONE +03-3274-5501 Musashino FAX: 03-3272-4366 Chemical Laboratory;Ltd. 1-1, KYOBASHI 1 CHOME, CHUO-KU YAESU•DAIBIRU BLDG. TOKYO 104 JAPAN •. -0031 Stevens Date : August $172,101 (k) To 18th, 1998 : US Department of Transportation Lactic Acid At t n. : Mr. Edward T. MAZZULLO : Director, Office of Hazardus Materials Statement 'From : YUKAWA Muneaki/ Manager of Teahnical Department Re : Lactic Acid Dear Mr. Mazzullo, . exporting laotic acid and its derivatives worldwidely. Recently we have had your opinion that lactic as restad, is not a corrosivo material: based on the definition for "correstro at 49 CFR 173.136, test criteria to determine the packing group of Class 8 material However we understand ihat lactic acid is a orrosive material based on the 1992 OECD Guide for Testing of Chemicals Number 404 Acute Dormal Irritation/Corrosion" which is attached. would like to take your comment whether Lactic acid is a corrosive or not. Please inform us your opionion for lactic acid. Best regards TEMPE ajutawam,#

Page 4198-8-18;10:11AM; #80 (#) # :03 3275 2206 # 2/2 2404• 7217.07.92 Adopted FOECD GUIDELINE FOR TESTING OF CHEMICALS Dcp: Organization for Ecomonic Cooperation end deme lime; Adopted by the Council on 17"' July 1992 •: Acute Dermal Irritation/Corrosion INTRODUCTION progress. In the review, special attention is given to possible improvements in relation to animal OECD Guidelines for Testing of Chemicals are periodically reviewed in light of scientific welfare. This updated version of the original guideline 404 (adopted in 1981) is the outcome of a meeting of OECD experts held in Paris in May 1991. ; • inclusion of data from in vitro tests in the information on which a decision not to proceed to an in vivo. The main differences between this and the original version of the guideline are: a) the allowing certain chemicals to be exempted from further testing. test can be based; and b) the possibility to use one animal in a first step of the in vivo procedure 3. Definitions used are set out in the Annex. INITIAL CONSIERATIONS 4. avoided, and that any testing which is likely to produce severe responses in animals is minimised. In the interests of animal welfare, it is important that the winecessary use of animals is Consequently, test materials meeting any of the following criteria should not be tested in animals for dermal irritation/corrosion: i) materials that have predictable corrosive potential based on structure-activity relationships and/or physicochemical properties such as strong acidity or alkalinity, or acidic reserve (1) should also be taken into account); e.g., when the material to be applied has a pit of 2 or less or 11.5 or greater (alkaline ịi) materials which have been shown to be highly toxic by the dermal route; iii) materials which, in an acute dermal toxicity test (2), have been shown not to produce irritation of the skin at the limit test dose level of 2000 mg/kg body weight. predicted on the basis of results from in vitro tests (3). In addition, it may not be necessary to test in vivo materials for which corrosive properties are PRINCIPLE OF THE IN VIVO TEST • 5. * The substance to be tested is applied in a single dose to the skin of one or more experiatental animals, untreated skin areas of the test animal (s) serving as control. The degree of irritation is read 1/6 ...#