DelValCo Consultants — Hazardous Materials Safety Interpretation

Page 1Transportatic S. Departme Wash ngton, D.C. 20590 400 Seventh Street, S.W. ipeline anc Administration lazardous Materials Safet JAN 11 2007 Mr. George M. Thorpe 21 Ardmoor Lane DelValCo Consultants Ref. No. 06-0247 Chadds Ford, PA 19317 Dear Mr. Thorpe: This responds to your letter regarding the shipment of Hydrogen peroxide, aqueous solution with more than 45 percent hydrogen peroxide by aircraft, in accordance with the small quantity exceptions in § 173.4 of the Hazardous Materials Regulations (HMR; 49 (totaling 2.38 ml per kit) in an outer packaging (kits per shipping case with a raximum CFR Parts 171-180). The kit consists of two plastic syringes, each containing 1.19 ml of four kits per case (totaling 9.52 ml per shipping case)). Under the HMR, a material described as "Hydrogen peroxide, aqueous solution with necessary), 5.1, UN2014, PG II" is forbidden for transportation by passenger and cargo- more than 40 percent but not more than 60 percent hydrogen peroxide (stabilized as only aircraft (see in §§ 171.11(c) and the 172.101 Table, Columns 9A and 9B). On March 22, 2006, [71 FR 14586; Docket HM-228] we published a final rule: which revised the small quantity exceptions in §173.4 and added a new Special Provision "A60" in §172.102. Special Provision "A60" permits articles such as sterilization devices, than 60 percent hydrogen peroxide (stabilized as necessary), when containing less than UN2014, Hydrogen peroxide, aqueous solutions with more than 40 percent but not more 30 ml per inner packaging with not more than 150 ml per outer packaging, to be transported in accordance with the provisions in §173.4, irrespective of 173.4(a)(11)(i), testing must show no difference in burning rate between a package as prepared for provided such packagings were first subject to comparative fire testing. Comparative fire transport (including the substance to be transported) and an identical package filled with I hope this satisfies your inquiry. If we can be of further assistance, please contact us Office of Hazardous Materials Standards 173.4 060247#

Page 2-narun 3143.4 Small Quantity 06-0247 DENSPLY Passional ritan PROFESSIONAL 1301 Smile Way P.O. Box 7807 2 May 2006 1800989-882: fork, PA 17404080) Fax: (717) 757-8250 717) 767-8500 DelValCo Consultants 21 Ardmoor Lane Atin: George M. Thorpe Chadds Ford, PA 19317 Vir. Thorpe: Dentsply Professional is requesting that that Nupro White Gold In-Office Tooth Whitening is comprised of two different gels filled into 2.5 cc syringes; the syringe serves as the inner System receive approval to be shipped via air under the small quantities exceptions. The product of 2.88 g of hydrogen peroxide in each kit; the kit (thermal formed tray with lid) serves as the package or primary container. Each kit contains two syringes of peroxide gel for a total volume shipment under small quantities exceptions with limits of 30 ml per inner package and 300 ml outer package. It is our understanding that ethylene oxide (UN 1040) is approved for air pe: outer package. Our product successfully passed testing under PG 1 conditions and in grater safety risk or hazard than the shipment of ethylene oxide. We base this belief on the fact accordance we believe that the shipment of hydrogen peroxide in limited quantities poses no limits for ethylene oxide and that the chemical characteristics (see Table A for comparison) of the quantity of hydrogen peroxide that we propose to ship is significantly lower than the shipping hydrogen peroxide are such that it is as safe or safer than ethylene oxide to ship in limited quantities via air travel. I appreciate your assistance with the request. Regands. Jones M. Sherman Senior Scientist Dentsply Professional MIDWEST* Cavitron" NUPRO DETON TRK: 2006060631 CA: 2004040027#

Page 3- Table A Characteristic Ethylotte Oxide Hydrogen Peroxide IATA UN# CASH 75-21-8 Hazard Class 1040 CAS #7722-84-1 2.3 2014 Flammable Physical State Gas Liquid Flash Point Yes, highly flammable No Vapor Pressure Oxidizer -4° F -20 °C Non-combustible Not available No Yes, strong oxidizer 18.3 mm Hg @30°C Vapor Density Products Hazardous Decomposition Carbon Monoxide, Carbon 1.52 g/1 Oxygen which supports Not available Stability Reacts violently with: Dioxide combustion alcohols, alkali metals, to heat and contarnination Stable (prolonged exposure hemically active metal mmonia, oxidizing agent: could cause decornposition) and their salts Target Organs Nerves, lungs Eyes, skin, nose, ihroat, IDSO Carcinogenicity 72 mg/kg lungs Carcinogen >225 mg/kg.. ACGIH, Animal Carcinogen#