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PUBLISHED UNITED STATES COURT of APPEALS for the FOURTH CIRCUIT ZENECA, INCORPORATED, Plaintiff-Appellant, V. DONNA E. SHALALA
PUBLISHED UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT ZENECA, INCORPORATED, Plaintiff-Appellant, v. DONNA E. SHALALA, in her official capacity as Secretary of Health and Human Services; JANE HENNEY, M.D., Commissioner of the Food No. 99-2329 and Drug Administration, Defendant-Appellees, v. GENSIA SICOR PHARMACEUTICALS, INCORPORATED, Movant-Appellee. Appeal from the United States District Court for the District of Maryland, at Baltimore. William M. Nickerson, District Judge. (CA-99-307-WMN) Argued: April 5, 2000 Decided: May 17, 2000 Before NIEMEYER, Circuit Judge, HAMILTON, Senior Circuit Judge, and Roger J. MINER, Senior Circuit Judge of the United States Court of Appeals for the Second Circuit, sitting by designation. _________________________________________________________________ Affirmed by published opinion. Senior Judge Hamilton wrote the opinion, in which Judge Niemeyer and Senior Judge Miner joined. COUNSEL Anthony Craig Roth, MORGAN, LEWIS & BOCKIUS, L.L.P., Washington, D.C., for Appellant. Gerald Cooper Kell, Senior Trial Counsel, Office of Consumer Litigation, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellees Sha- lala and Henney; David Glenn Adams, VENABLE, BAETJER, HOWARD & CIVILETTI, L.L.P., Washington, D.C., for Appellee Gensia Sicor. ON BRIEF: Stephen P. Mahinka, MORGAN, LEWIS & BOCKIUS, L.L.P., Washington, D.C., for Appellant. David W. Ogden, Acting Assistant Attorney General, Office of Consumer Liti- gation, UNITED STATES DEPARTMENT OF JUSTICE, Washing- ton, D.C.; Barbara J. Stradling, Associate Chief Counsel for Enforcement, FOOD AND DRUG ADMINISTRATION, Washing- ton, D.C., for Appellees Shalala and Henney. James N. Czaban, VEN- ABLE, BAETJER, HOWARD & CIVILETTI, L.L.P., Washington, D.C., for Appellee Gensia Sicor. -
Sulfite: Here, There, Everywhere
Sulfite: Here, There, Everywhere Max T. Baker, PhD Associate Professor Department of Anesthesia University of Iowa Inadvertent Exposures Combustion of fossil fuels, Air pollutant Large quantities as sulfur dioxide are expelled from volcanos Kilauea on the Big Island Small quantities endogenously formed in mammals from sulfur-containing amino acid metabolism Deliberate Exposures As Preservative- Wine, Beer (dates to Roman times From burning sulfur candles) Fruits and Vegetables (reduce browning, extend shelf-life) Pharmaceuticals1 Reductant - Antioxidant - Antimicrobial What are Sulfites? Oxidized Forms of the Sulfur Atom Sulfur Dioxide, MW = 64, bp = - 10oC (gaseous) Sulfur (IV) - Oxidation state of 4 S = Atomic number 16 – electrons/shell, 2,8,6 Sodium Dioxide Readily Hydrates2 Sulfur Carbon Dioxide Dioxide (irritant) H O H2O 2 Sulfurous Unstable Carbonic low acid species acid pH high pH Bisulfite Bicarbonate anion anion Sulfite Carbonate dianion dianion Forms radical Doesn’t form radical Bisulfite Can Combine with SO2 to form Metabisulfite + excess Bisulfite Metabisulfite (disulfite, pyrosulfite) “Sulfite” usually added to drugs as sodium or potassium salts of: Sulfite, Bisulfite, or Metabisulfite Endogenous to Mammals Small quantities formed from sulfur-containing amino acid metabolism - cysteine, methionine3 + - + H2O + 2H + 2 e Sulfite Sulfate Rapidly detoxified by sulfite oxidase (SOX) to form sulfate – a two electron oxidation, molybdenum dependent Two Confirmed Sulfite Toxicities Neurological abnormalities from genetic sulfite oxidase deficiency3 Allergic reactions from exogenous exposure4 Oral, parenteral, inhalational exposure: dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhea to life- threatening anaphylactic and asthmatic reactions “The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people." - FDA Prevalence – 3-10% are sulfite sensitive among asthmatic subjects. -
Reregistration Eligibility Decision (RED) for Inorganic Sulfites
Reregistration Eligibility Decision – Inorganic Sulfites May 2007 Reregistration Eligibility Decision Inorganic Sulfites Special Review and Reregistration Division Office of Pesticide Programs U.S. Environmental Protection Agency 1801 South Bell Street Arlington, VA 22202 Introduction The Environmental Protection Agency (EPA) has completed its Reregistration Eligibility Decision (RED) for the inorganic sulfites case, which includes the chemicals sulfur dioxide and sodium metabisulfite. This assessment provides information to support the issuance of a Reregistration Eligibility Decision for inorganic sulfites. EPA’s pesticide reregistration process provides for the review of older pesticides (those initially registered prior to November 1984) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that they meet current scientific and regulatory standards. In this document, EPA presents the results of its review of the potential human health effects of dietary, drinking water and occupational/bystander exposure to inorganic sulfites, as well as its ecological risk findings. Evaluations performed by the World Health Organization (WHO), the International Agency for Research on Cancer (IARC), and the Agency for Toxic Substances and Disease Registry (ATSDR) were relied upon for this assessment, in addition to peer-reviewed evaluations performed by the Cosmetic Ingredient Review (CIR), the Organization for Economic Cooperation and Development-Screening Information Data Set (OECD-SIDS) and from other open literature sources. Based on this assessment, the Agency has determined that products containing sulfur dioxide or sodium metabisulfite are eligible for reregistration provided the necessary label changes are made. As a result of this assessment, one tolerance has been reassessed. I. Use Information The inorganic sulfites reregistration case includes the chemicals sulfur dioxide (CAS No. -
DRY ACID Safety Data Sheet (SDS No
Safety Data Sheet (SDS No. 207) HASA DRY ACID HASA DRY ACID Safety Data Sheet Emergency 24 Hour Telephone: CHEMTREC 800.424.9300 Corporate Headquarters: Hasa Inc. P. O. Box 802736 Santa Clarita, CA 91355 Telephone 661.259.5848 Fax 661.259.1538 SECTION 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION 1.1 Product Identification: 1.1.1 Product Name: HASA DRY ACID 1.1.2 CAS # : (Chemical Abstract Service) 7681-38-1 1.1.3 RTECS : (Registry of Toxic Effects VZ1860000 of Chemical Substances) 1.1.4 EINECS : (European Inventory of 231-665-7 Existing Commercial Substances) 1.1.5 Chemical Name: Sodium bisulfate 1.1.6 Chemical Formula: NaHSO 4 1.1.7 Chemical Family: Inorganic acid salt 1.1.8 Synonym: Sodium Acid Sulfate, Sodium Hydrogen Sulfate, Sodium Pyrosulfate. 1.2 Recommended Uses: It is used primarily to lower the pH of water for effective chlorination, including swimming pools and spas. 1.3 Company Identification: Hasa Inc. P. O. Box 802736 Santa Clarita, CA 91355 1.4 Emergency Assistance: CHEMTREC : 1-800-424-9300 (24 Hour Emergency Telephone) 1.5 Non -Emergency Assistance : 661-259-5848 (8 AM – 5 PM PST / PDT) Revision Date: 01/01/2015 (Supersedes previous revisions) Page 1 of 9 SECTION 2: HAZARD(S) IDENTIFICATION Safety Data Sheet (SDS No. 207) HASA DRY ACID Hazard Category Skin corrosion / irritation: Category 1 Acute Toxicity (oral): Category 4 Acute Toxicity (inhalation): Category 4 Symbol Signal Word DANGER Haza rd Statements Causes severe skin burns and eye damage. Harmful if inhaled. Harmful if swallowed. Precautionary Prevention Statements Do not breathe dusts or mists. -
Sodium Metabisulfite Hypersensitivity in Urticaria
Our Dermatology Online Original Article SSodiumodium mmetabisulfietabisulfi ttee hhypersensitivityypersensitivity iinn uurticariarticaria Beata Sadowska, Marlena Sztormowska, Marika Gawinowska, Marta Chelminska Department of Allergology, Allergology and Pneumonology Clinic, Medical University of Gdansk, Smoluchowskiego 17, 80- 214 Gdansk, Poland Corresponding author: Beata Sadowska, MD, E-mail: [email protected] ABSTRACT Background: Sodium metabisulfite is a recognized, but rare, trigger of urticaria, wherein the IgE mechanism has been sporadically proven. The aim of this study was to identify the potential reaction to sodium metabisulfite (MBS) based on a placebo-controlled oral challenge in patients with urticaria and suspected hypersensitivity to food additives. Materials and Methods: A total of 110 adult patients (76 females and 34 males with a mean age of 46 years) were included in the study between 2017 and 2019. All subjects underwent MBS skin prick tests (SPT) and patch tests (PT). Patients with a positive skin test or suspected MBS hypersensitivity were qualified for a placebo-controlled oral challenge (OC). Results: Skin testing was positive in 24 patients: SPT in 20% (n = 22), PT in 5% (n = 6). Out of 64 oral challenges, 13 positive results were obtained. Patients with a positive challenge typed sulfite foods twice as often as a culprit compared to those with a negative OC. Conclusions: In patients with urticaria, both the IgE and non-IgE mechanism of MBS hypersensitivity has been demonstrated. Skin tests with a detailed medical history of potentially guilty foods may be helpful in determining sulfite hypersensitivity. Key words: Sulfites; Sodium metabisulfite; Urticaria; Food additive hypersensitivity INTRODUCTION they are not obliged to disclose the total amount of the substance [5]. -
Safety Assessment of Sulfites As Used in Cosmetics
Safety Assessment of Sulfites as Used in Cosmetics Status: Re-Review for Panel Consideration Release Date: August 22, 2019 Panel Meeting Date: September 16-17, 2019 The 2019 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D., Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart Heldreth, Ph.D. This safety assessment was prepared by Wilbur Johnson, Jr., Senior Scientific Analyst © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Wilbur Johnson, Jr. Senior Scientific Analyst Date: August 22, 2019 Subject: Re-Review of the Safety Assessment of Sulfites The CIR Expert Panel first reviewed the safety of Sulfites in 2003. The Panel concluded that Ammonium Bisulfite, Ammonium Sulfite, Potassium Metabisulfite, Potassium Sulfite, Sodium Bisulfite, Sodium Metabisulfite, and Sodium Sulfite are safe as used in cosmetic formulations. The original report is included for your use (identified as sulfit092019orig in the pdf). Minutes from the deliberations of the original review are also included (sulfit092019min_orig). Because it has been at least 15 years since the safety assessment was published, in accordance with CIR Procedures, the Panel should consider whether the safety assessment of Sulfites should be reopened. -
Purification Method of Pemetrexed Salts,Sodium Salts and Disodium Salts
(19) & (11) EP 2 213 674 A1 (12) EUROPEAN PATENT APPLICATION published in accordance with Art. 153(4) EPC (43) Date of publication: (51) Int Cl.: 04.08.2010 Bulletin 2010/31 C07D 487/04 (2006.01) A61K 31/519 (2006.01) A61P 35/00 (2006.01) (21) Application number: 08844190.2 (86) International application number: (22) Date of filing: 21.10.2008 PCT/CN2008/072758 (87) International publication number: WO 2009/056029 (07.05.2009 Gazette 2009/19) (84) Designated Contracting States: • LIN, Meng AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Chongqing 400061 (CN) HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT • LIN, Bo RO SE SI SK TR Chongqing 400061 (CN) Designated Extension States: • YE, Wenrun AL BA MK RS Chongqing 400061 (CN) • QIN, Yongmei (30) Priority: 24.10.2007 CN 200710092879 Chongqing 400061 (CN) •DENG,Jie (71) Applicant: Chongqing Pharmaceutical Chongqing 400061 (CN) Research Institute Co., Ltd. Chongqing 400-061 (CN) (74) Representative: Epping - Hermann - Fischer Patentanwaltsgesellschaft mbH (72) Inventors: Ridlerstrasse 55 •LUO,Jie 80339 München (DE) Chongqing 400061 (CN) (54) PURIFICATION METHOD OF PEMETREXED SALTS,SODIUM SALTS AND DISODIUM SALTS + + (57) A method of purifying a salt of pemetrexed have a structure of formula (III) by salting-out, wherein if M 3 is H , + + + + + + + + + + then each of M1 and M2 is independently H , Li , Na or K , provided that both of them are not H ; if M3 is Li , Na + + + + + + or K , then each of M1 and M2 is independently Li , Na or K . -
Sulfur Dioxide and Some Sulfites, Bisulfites and Metabisulfites
SULFUR DIOXIDE AND SOME SULFITES, BISULFITES AND METABISULFITES 1. Exposure Data 1.1 Chemical and physical data 1.1.1 Synonyms and structural and molecular data Sulfr dioxi Chem. Abstr. Serv Reg. No.: 7446-09-5 Replaced CAS Nos.: 8014-94-6; 12396-99-5; 83008-56-4; 89125-89-3 Chem. Abstr. Name; Sulfur dioxide IUPAC Systematic Name: Sulfur dioxide Synonyms: Sulfurous acid anhydride; sulfurous anhydride; sulfurous oxide; sulfur oxide (S02); sulfur superoxide; sulphur dioxide 0=8=0 S02 MoL. wt: 64.07 Sodium sulfte Chem. Abstr. Serv Reg. No.: 7757-83-7 Altemate CAS No.: 10579-83-6 Replaced CAS No.: 68135-69-3 Chem. Abstr. Name: Sulfurous acid, di sodium salt IUPAC Systematic Name: Sulfurous acid, disodium salt Synonyms: Anhydrous sodium sulfite; disodium sulfite; sodium sulphite o 1/ Na · 0 - 8 - 0 · Na Na2S0J MoL. wt: 126.04 Sodium bisulfe Chem. Abstr. Serv Reg. No.: 7631-90-5 Replaced CAS Nos.: 57414-01-4; 69098-86-8; 89830-27-3; 91829-63-9 Chem. Abstr. Name: Sulfurous acid, monosodium salt IUPAC Systematic Name: Sulfurous acid, monosodium salt -131- 132 lARe MONOGRAPHS VOLUME 54 Synonyms: Hydrogen sulfite sodium; monosodium sulfite; sodium acid sulfite; sodium bisulphite; sodium hydrogen sulfite; sodium sulfite (NaHS03) o Il HO - S - a · Na NaHS03 MoL. wt: 104.06 Sodium metabisulfte Chem. Abstr. Serv Reg. No.: 7681-57-4 Altemate CAS No.: 7757-74-6 Replaced CAS No.: 15771-29-6 Chem. Abstr. Name: Disulfurous acid, disodium salt IUPAC Systematic Name: Pyrosulfurous acid, disodium salt Synonyms: Disodium disulfite; disodium metabisulfite; disodium pyrosulfite; sodium disulfite; sodium metabisulphite; sodium pyrosulfite oIl Il0 Na · 0- S - a - S - a · Na .Na2S20S MoL. -
Chemical Pretreatment for RO and NF
Chemical Pretreatment For RO and NF October 2013 Lenntech [email protected] Tel. +31-152-610-900 www.lenntech.com Fax. +31-152-616-289 There are a number of chemicals that can be introduced into the RO feed to enhance the operation of the RO system. Acids Caustic Dechlorination chemicals Antiscalants and Dispersants Acids: Acids, typically hydrochloric [HCl] or sulfuric [H2SO4], are injected into the RO feed to lower pH. Sulfuric acid is used more often than HCl acid. One reason for this is because sulfuric acid is relatively lower in operating cost than HCl acid. Another advantage to using sulfuric over HCl is the reduced fuming to the atmosphere, which means less corrosion to surrounding metal components. Sulfuric acid is sometimes preferred over HCl since there is a better membrane rejection of the sulfate ion than the chloride ion. Technical grade sulfuric acid, with no other additives, is suitable for use with a RO. Sulfuric acid is commercially available as a 20% and 93% solution. The 93% solution is also referred to as “66 0 Baume solution”. Caution is required in diluting 93% sulfuric acid, since the maximum heat of dilution of about 280 F occurs around 60%. It is critical that the concentrated acid is added slowly to the top of dilution water that is being agitated to minimize the buildup of heat and boiling of the makeup solution. Hydrochloric acid is preferred when calcium sulfate, barium sulfate, or strontium sulfate scaling is a concern. Sulfuric acid increases the sulfate ion level in the RO feed, which directly increases the potential for sulfate-based scaling. -
Sodium Metabisulfite
Sodium metabisulfite sc-203389 Material Safety Data Sheet Hazard Alert Code EXTREME HIGH MODERATE LOW Key: Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION PRODUCT NAME Sodium metabisulfite STATEMENT OF HAZARDOUS NATURE CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO OSHA 29 CFR 1910.1200. NFPA FLAMMABILITY0 HEALTH3 HAZARD INSTABILITY1 SUPPLIER Company: Santa Cruz Biotechnology, Inc. Address: 2145 Delaware Ave Santa Cruz, CA 95060 Telephone: 800.457.3801 or 831.457.3800 Emergency Tel: CHEMWATCH: From within the US and Canada: 877-715-9305 Emergency Tel: From outside the US and Canada: +800 2436 2255 (1-800-CHEMCALL) or call +613 9573 3112 PRODUCT USE ■ Reducing agent. Reagent. Widely used in food as preservative; as Food Additive 223. Amounts in foods are subject to regulation. Usually only 0.01 to 0.10%. Used as a reagent and as a source of sulfur dioxide. Used to deactivate isothiazolone biocides. SYNONYMS Na2-S2-O5, "SBS powder", SMBS, "Food Additive 223", "disodium pyrosulphite", "pyrosulfurous acid, disodium salt", "sodium pyrosulfite", "disodium pyrosulfite", "sodium meta-bisulphite", "sodium meta-bisulfite", "anhydrous sodium bisulfite", "SMB POwder", APS, FOOD00004251, AR00000487, 04506808, 015705, "Redox SOMETA39", Nalco, "IONAC 140" Section 2 - HAZARDS IDENTIFICATION CANADIAN WHMIS SYMBOLS EMERGENCY OVERVIEW RISK Harmful if swallowed. Contact with acids liberates toxic gas. Risk of serious damage to eyes. Irritating to respiratory system and skin. POTENTIAL HEALTH EFFECTS ACUTE HEALTH EFFECTS SWALLOWED ■ Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual. ■ Ingestion of sulfite salts may cause gastric irritation. -
Coei-1-Potanh: 2000
INTERNATIONAL ŒNOLOGICAL CODEX Potassium Anhydrous Sulfite COEI-1-POTANH: 2000 POTASSIUM ANHYDROUS SULFITE Potassium pyrosulfite Potassium disulfite Potassium metabisulfite Kalii metabisulfis K2S2O5 = 222.3 SIN No. 224 (Oeno 34/2000) 1. OBJECTIVE, ORIGIN AND SCOPE OF APPLICATION Potassium anhydrous sulfite, commonly called potassium metabisulfite, is used because of the sulfur dioxide it makes available. Potassium metabisulfite, which is sold in powdered form, contains 52- 55% by weight SO2. There are regulatory limits restricting the sulfur dioxide content of wines. 2. LABELING The label should indicate the product's purity as well as its safety and storage conditions. 3. CENTESIMAL COMPOSITION Sulfur dioxide 57.63 Potassium 35.17 4. SOLUBILITY Water at 20 °C 454.5 g/l Alcohol, 95% by vol. insoluble 5. IDENTIFYING PROPERTIES 5.1. 5 ml of aqueous 10 pp 100 (m/v) solution treated with 5 ml of 1/10 diluted sulfuric acid (R) releases sulfur dioxide and reduces iodine and potassium permanganate. 5.2. The 10 pp 100 (m/v) aqueous solution is acidic as indicated by methyl red (R) of (pHapproximately 5). E-COEI-1-POTANH 1 INTERNATIONAL ŒNOLOGICAL CODEX Potassium Anhydrous Sulfite COEI-1-POTANH: 2000 5.3. The 1 pp 100 (m/v) aqueous solution produces potassium- based reactions. 6. TESTS 6.1. Preparing the Test Solution in a Concentration of 10 pp 100 Prepare a solution in a concentration of 10 pp 1000 (m/v). 6.2. Preparing a Test Solution in a Concentration of 1 pp 100 Prepare a 1 pp 100 (m/v) solution by diluting the previous solution (6.1) to 1/10. -
Substance Evaluation Report 2014 – Disodium Disulphite
SUBSTANCE EVALUATION REPORT 2014 – DISODIUM DISULPHITE SUBSTANCE EVALUATION REPORT Public Name: Disodium disulphite EC Number(s): 231-673-0 CAS Number(s): 7681-57-4 Submitting Member State Competent Authority: National Institute of Chemical Safety, Hungary H-1097 Budapest, Nagyvárad tér 2. tel: +36 1 476 1195 Year of evaluation (as given in the CoRAP): 2014 VERSION NUMBER: 1 DATE: 30.10.2015 Conclusions of the most recent evaluation step* Tick relevant box(es) Concern not clarified; Need to request further information from the Registrant(s) with the draft decision Concern clarified; No need of further risk management measures Concern clarified; Need for risk management measures; RMO analysis to be performed Other: Concern clarified; need for risk management measure (proposal for X harmonized C&L), but no need for RMOA *Include details in the executive summary. 1 SUBSTANCE EVALUATION REPORT 2014 – DISODIUM DISULPHITE DISCLAIMER The Substance evaluation report has been prepared by the evaluating Member State as a part of the substance evaluation process under the REACH Regulation (EC) No 1907/2006. The information and views set out in this document are those of the author and do not necessarily reflect the position or opinion of the European Chemicals Agency or other Member States. The Agency does not guarantee the accuracy of the information included in the document. Neither the Agency nor the evaluating Member State nor any person acting on either of their behalves may be held liable for the use which may be made of the information contained therein. Statements made or information contained in the document are without prejudice to any further regulatory work that the Agency or Member States may initiate at a later stage.