United States Office of Pflftidd* and Toxic Sutetanca Environmental Protection Office of Pesticide Program* (TS-766C) Agency Washington. DC 20460 SEPA Pesticide Fact Sheet Name of Chemical: ^^ BROraDE Reason for Issuance: Date Issued: ^ ^nnA - - «, i.Sepfc- 30, 1984 Fact Sheet Number: 38 1. Description of Chemical Generic Namer Potassium Bromide Common Name: Potassium Bromide Trade Name: Potassium Bromide EPA Shaughnessy Code No. 041101 Chemical Abstracts Service No. 775802-3 Year of initial registration: 1960 Pesticide Type: Disinfectant Chemical Family: Inorganic Halogen O.S» and Foreign Producers: Many U.S. chemical supply houses, e.g. J. T. Baker Chemical Co., Mallinckrodt, etc. probably many foreign producers. 2. Use Patterns and Formulations Application Sites: Food contact surfaces, food handling equipment* eating utensils in food processing establishments Types of formulations: granular powder Types and methods of application: Dipping utensils in a tankr or by spraying Application. J a test 1 oz in 10 gallons of water Usual Carriers: the granular product is mixed with other chemicals generally recognized a? safe; the use solution is prepared with water —r *^ f _ 3. Scie'icg Findings: Cheir.ical Characteristics: Physical State; solid Colorr white granules, colorless crystals Odor: None Melting Point: 730°C Density: 2.75 ------- (2) POTASSIUM BROMIDE FACT SHEET 4. ToxicologiCal Characteristics Technical Grade of Potassium Bromide (99% KBr): large doses COUBC central nervous system depression: prolonged intake may cause mental deterioration, acneform skin eruptions (Merck Index, 4th Edition). Chronic Toxicity: Evaluation of available information tram the published literature raises no tonerns related to chron- ic adverse effects The registered product covered by the standard is in catego- ry 11, based on the approved label. S. Physiological and Piochemical Behavioral Characteristics N/A 6. Environmenta’ Characteristics N/A 7. Characteristics N/A 8. Tolerance Assessments Potassium Bromide, together with other cheLlicals generally recoo.riized a.s safe . is cleared for use as a final sanitix— ing rinse for food contact surtaceB, fooà handling equip- ment and eating utensils, in food processing establishments, under Section 178.1010 of Title 21 of the Code of Federal Regulations, which is administered by the Food and Drug Administration. All end—use products proposed for regis- tration under the standard must co p1y with the provision of this section. 10. Problems with Chemical The technical grade of the active ingredient is not regis- tered as a manufacturing—use product. To register it tor for the use covered in the standard the registrant must satisfy the data requirements specified in Table A of the standard. ------- (3) POTASSIUM BROMIDE FACT SHEET End—Use Products: If a registrant qualifies for the formulator’s exemption be or she may register the end—use product for the use covered by the standard by satisfying the data requirements listed in Table B of the standard. If a registrant does not qualify for the formulator’s exemption he or she must address and satisfy the data requirements specified in Table A, f or the technical grade of the active ingredient, as veil as those specified in Table B, for the end—use product. 10. Summary Science Statement A review of available information from the published litera- ture on Potassium Bromide has not raised any concerns rela- ted to long term or chronic adverse effects for the regis- tered use. 11. Summary of Regulatory Position and Pationale Use C1assification General Use formulation, or geographical restrictions: The regis— trered use is as a final sanitizing rinse on food contact surfaces; the formulated product must be substantially si- milar to the registered use covered in the standard; there are no geographical restrictions. tnere are no unique warning statements for the registered product. The technical grade of Potassium Bromide is not registered as a manufacturing—use product. To register it for the use covered in the standard the registrant must address and sa- tisfy the data requirements listed n Table A of the stand— .ard 2 hese includa -acute toxicity, data. a ecologica3. et- feats data • End—use product registrants who quality under the formulator’s exemption need only address and satisfy the data requirements listed in Table B of the standard. End— use product registrants who do not ;ualify undej the formu— 1ator s exemption must address both sets of date requirements. Registrants must respond to the standard withir! 90 days froit the date the standard is issued; and con it themselves to ad- dress and ad&fy the data requirements within 6 months tror the 90 day response dade. 12. St ary of data gaps and dates when these data gaps are due to be filled. Acute toxicity data and fish and wildlife date for the technical grade of Potassium Bromide as specified. in Table A of the standard. Acute toxicity data to register end—use products as specified in Table B of the standard. ------- 14) 13. EPA Contact: Arturo Castillo, PM 32. Registration Division (TS—767C) EPA, 401 M St., S. W., Washington, D. C., 703—557—13964 DISCLAIMER: The information presented in this Chemical Informa- tion Fact Sheet is for informational purposes only and may not be used to fulfill data requirements for pesticide registration and re—registraltion. used to fulfill data requirements for pesticide registration and re—registration. ------- |