Experience with Alternatives to Thiomersal from Other Fields a Survey Amongst IABS Members
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Quaternary Ammonium Compounds
FACT SHEET: Quaternary Ammonium Compounds Quaternary ammonium compounds, also known as “quats” or “QACs,” include a number of chemicals used as sanitizers and disinfectants, including benzalkonium chloride, benzethonium chloride, cetalkonium chloride, cetrimide, cetrimonium bromide, cetylpyridinium chloride, glycidyl trimethyl, ammonium chloride, and stearalkonium chloride.[i] In general, quats cause toxic effects through all Mutagenicity routes of exposure including inhalation, Some quats have shown to be mutagenic and to ingestion, dermal application, and irrigation of damage animal DNA and DNA in human body cavities. Exposure to diluted solutions may lymphocytes at much lower levels than are result in mild irritation, while concentrated present in cleaning chemicals.[6] solutions are corrosive, causing burns to the skin and mucous Membranes. They can produce Antimicrobial Resistance systemic toxicity and can also cause allergic Genes have been discovered that mediate reactions.[2] resistance to quats. There has been an association of some of these genes with beta lactamase genes, Asthma and Allergies raising concern for a relationship between Of particular interest with regard to use as disinfectant resistance and antibiotic resistance.[7] disinfectants in the COVID-19 pandemic, quats increase the risk for asthma and allergic Reproductive Toxicity sensitization. Evidence from occupational Mice whose cages were cleaned with QACs had exposures shows increased risk of rhinitis and very low fertility rates. [8] Exposure to a common asthma -
FDA-2015-N-0101; and FDA-2016-N-0124
DE PARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 November 18, 2020 Docket Nos. FDA-1975-N-0012; FDA-2015-N-0101; and FDA-2016-N-0124 The American Cleaning Institute Attention: James Kim, PhD Vice President, Science and Regulatory Affairs 1401 H Street, N.W. Suite 700 Washington, D.C. 20005 Re: Benzalkonium Chloride, Benzethonium Chloride, Chloroxylenol, Ethanol, and Povidone-Iodine Dear Dr. Kim: This letter responds to The American Cleaning Institute’s (ACI’s) July 14, 2020 communication regarding the deferral from final rulemaking under the over-the-counter (OTC) Drug Review on benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine for use in nonprescription (often referred to as over-the-counter or OTC) consumer antiseptic wash, health care antiseptic, and consumer antiseptic rub drug products. In March 2016, FDA issued letters granting requests to defer three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol—from inclusion in the final rulemaking for the December 2013 proposed rule for OTC consumer antiseptic washes (78 FR 76444). Similarly, in January 2017, FDA issued letters granting requests to defer six active ingredients—benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, povidone- iodine, and isopropyl alcohol—from inclusion in the final rulemaking for the May 2015 proposed rule for OTC health care antiseptics (80 FR 25166). In October 2017, FDA issued letters granting requests to defer three active -
Phenol Health and Safety Guide
C - z_ IPCS INTERNATIONAL._ PROGRAMME ON CHEMICAL SAFETY OD 341 Health and Safety Guide No. 88 .P5 94 Ph c.2 PHENOL HEALTH AND SAFETY GUIDE ' UNITED NATIONS INTERNATIONAL ENVffiONMENTPROG~E LABOUR ORGANISATION WORLD HEALTH ORGANIZATION WORLD HEALTH ORGANIZATION, GENEVA 1994 1 I) 1\ ' ~Ii>cs Other HEALTH AND SAFETY GUIDES available: (continued on inside back cover) Acrolein (No . 67, 1992) Endrin (No. 60, 1991) Acrylamide (No. 45 , 1991) Epichlorohydrin (No. 8, 1987) Acrylonitrile (No. I, 1986) Ethylene oxide (No. 16, 1988) Aldicarb (No. 64, 1991) Fenitrothion (No. 65, 1991) Aldrin and dieldrin (No. 21 , 1988) Fenvalerate (No. 34, 1989) Allethrins (No. 24, 1989) Folpet (No. 72, 1992) Amitrole (No. 85 , 1994) Formaldehyde (No. 57, 1991) Ammonia (No. 37, 1990) Heptachlor (No. 14, 1988) Arsenic compounds, inorganic, other than Hexachlorobutadiene (No. 84, 1993) arsine (No. 70, 1992) Hexachlorocyclohexanes, alpha- and Atrazine (No. 47, 1990) beta- (No. 53, 1991) Barium (No. 46 , 1991) Hexachlorocyclopentadiene (No. 63 , 1991) Benomyl (No. 81, 1993) n-Hexane (No. 59, 1991) Bentazone (No. 48, 1990) Hydrazine (No. 56, 1991) Beryllium (No. 44, 1990) Isobenzan (No. 61 , 1991) !-Butanol (No. 3, 1987) Isobutanol (No. 9, 1987) 2-Butanol (No. 4, 1987) Kelevan (No. 2, 1987) ten-Butanol (No. 7, 1987) Lindane (No. 54 , 1991) Camphechlor (No. 40, 1990) Magnetic fields (No. 27, 1990) Captafol (No. 49, 1990) Methamidophos (No. 79, 1993) Captan (No. 50, 1990) Methyl bromide (Bromomethane) (No. 86, 1994) Carbaryl (No. 78, 1993) Methyl isobutyl ketone (No. 58, 1991) Carbendazim (No. 82, 1993) Methyl parathion (No. 75, 1992) Chlordane (No. 13 , 1988) Methylene chloride (No. -
A Screening-Based Approach to Circumvent Tumor Microenvironment
JBXXXX10.1177/1087057113501081Journal of Biomolecular ScreeningSingh et al. 501081research-article2013 Original Research Journal of Biomolecular Screening 2014, Vol 19(1) 158 –167 A Screening-Based Approach to © 2013 Society for Laboratory Automation and Screening DOI: 10.1177/1087057113501081 Circumvent Tumor Microenvironment- jbx.sagepub.com Driven Intrinsic Resistance to BCR-ABL+ Inhibitors in Ph+ Acute Lymphoblastic Leukemia Harpreet Singh1,2, Anang A. Shelat3, Amandeep Singh4, Nidal Boulos1, Richard T. Williams1,2*, and R. Kiplin Guy2,3 Abstract Signaling by the BCR-ABL fusion kinase drives Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) and chronic myelogenous leukemia (CML). Despite their clinical activity in many patients with CML, the BCR-ABL kinase inhibitors (BCR-ABL-KIs) imatinib, dasatinib, and nilotinib provide only transient leukemia reduction in patients with Ph+ ALL. While host-derived growth factors in the leukemia microenvironment have been invoked to explain this drug resistance, their relative contribution remains uncertain. Using genetically defined murine Ph+ ALL cells, we identified interleukin 7 (IL-7) as the dominant host factor that attenuates response to BCR-ABL-KIs. To identify potential combination drugs that could overcome this IL-7–dependent BCR-ABL-KI–resistant phenotype, we screened a small-molecule library including Food and Drug Administration–approved drugs. Among the validated hits, the well-tolerated antimalarial drug dihydroartemisinin (DHA) displayed potent activity in vitro and modest in vivo monotherapy activity against engineered murine BCR-ABL-KI–resistant Ph+ ALL. Strikingly, cotreatment with DHA and dasatinib in vivo strongly reduced primary leukemia burden and improved long-term survival in a murine model that faithfully captures the BCR-ABL-KI–resistant phenotype of human Ph+ ALL. -
Chemical Matricectomy with Phenol Versus Aesthetic Reconstruction. a Single Blinded Randomized Clinical Trial
Journal of Clinical Medicine Article The Treatment of Ingrown Nail: Chemical Matricectomy With Phenol Versus Aesthetic Reconstruction. A Single Blinded Randomized Clinical Trial Juan Manuel Muriel-Sánchez 1, Ricardo Becerro-de-Bengoa-Vallejo 2 , Pedro Montaño-Jiménez 1 and Manuel Coheña-Jiménez 1,* 1 Facultad de Enfermería, Fisioterapia y Podología, Universidad de Sevilla, 41009 Sevilla, Spain; [email protected] (J.M.M.-S.); [email protected] (P.M.-J.) 2 Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain; [email protected] * Correspondence: [email protected] Received: 29 January 2020; Accepted: 18 March 2020; Published: 20 March 2020 Abstract: Background: In onychocryptosis surgery, incisional and non-incisional matricectomy is indicated according to the stage. The chemical matricectomy with 88% phenol solution is the gold standard and a wedge resection is indicated for more advanced stages. The aesthetic reconstruction has the advantages of the incisional procedure without eponychium incisions and an effectiveness similar to the chemical matricectomy with phenol. Objective: To compare the recurrence and the healing time between the chemical matricectomy with phenol and the aesthetic reconstruction. Methods: A comparative, prospective, parallel, randomized, and one-blinded clinical trial was registered with the European Clinical Trials Database (EudraCT) with identification number 2019-001294-80. Thrity-four patients (56 feet) with 112 onychocryptosis were randomized in two groups. Thirty-six were treated with chemical matricectomy with phenol and 76 with aesthetic reconstruction. Each patient was blind to the surgical procedure assigned by the investigator. The primary outcome measurements were healing time and recurrence. The secondary outcome measurements were post-surgical bleeding, pain, inflammation, and infection rate. -
Partial Nail Avulsion and Chemical Matricectomy: Ingrown Toenails
Partial nail avulsion and chemical matricectomy: Ingrown toenails Intervention Removal (avulsion) of an ingrowing section of toenail and application of a caustic chemical to destroy the nail matrix (matricectomy). Indication Partial nail avulsion and chemical matricectomy relieve symptoms and prevent regrowth of the nail edge or recurrence of the ingrowing toenail. Possible causes of ingrowing toenails include improper Ingrowing toenails are a common problem and occur when the edge of the nail grows trimming of the nail, tearing nail into flesh at the side of the nail, causing a painful injury. The punctured skin can become off, overly curved nail, certain inflamed and infected. Ingrown toenails can be classified into three stages (see Figure 1): activities (eg running) and • mild (or Stage I) wearing constricting footwear. – oedema, erythema and pain • moderate (or Stage II) – inflammation and inflection with or without purulent discharge, in addition to the symptoms of Stage I • severe (or Stage III) – chronic inflammation, epithelialised hypertrophic granulation tissue. Figure 1. Three stages of ingrown toenails Source: Eekhof JA, Van Wijk B, Knuistingh Neven A, van der Wouden JC. Interventions for ingrowing toenails. The Cochrane Database of Systematic Reviews 2012;4:CD001541. Surgical interventions are commonly performed for patients in Stages II and III, and are more effective than non-surgical interventions in preventing the recurrence of an ingrowing toenail. The addition of chemical cauterisation (most commonly with phenol) at Stages II and III, may be more effective in preventing recurrence and regrowth of the ingrowing toenail than surgery alone. Contraindications Diminished vascular supply to the digit is a relative contraindication to nail surgery. -
Hatchery Disinfection Policy and Procedures
MAINE DEPARTMENT OF INLAND FISHERIES & WILDLIFE Chapter 11 Disinfection Policy & Procedures Editors: David C. Rayner, Fish Culture Supervisor, Governor Hill State Fish Hatchery, Augusta, Maine (19XX- Present) & G. Russell Danner MS, DVM, Fish Pathologist, Fish Health Laboratory, Augusta, Maine (1998 – Present) Date: September 24, 1999. “Or if a person touches anything ceremonially unclean-whether the carcasses of unclean wild animals or of unclean livestock or of unclean creatures that move along the ground-even though he is unaware of it, he has become unclean and is guilty” Lev. 5:2 Several factors should be included in an evaluation of a disinfectant. A prerequisite for a disinfectant is its effectiveness against the expected spectrum of pathogens (Table 11- 1, 11-2, and 11-3). A general guideline for effective killing of pathogens by a disinfectant is a 5-log killing of bacteria and a 4-log killing of viruses. In addition to the activity of the disinfectant, its compatibility with devices should be reviewed in detail; this should include a review of data on devices that have been immersed for longer than recommended times. Instruments can be forgotten after immersion, and this mistake should not necessarily result in irreparable damage to the device. Other issues are toxicity, odor, compatibility with other compounds, and residual activity. Various and numerous organisms can cause diseases in fish. Viruses, bacteria, fungi, protozoan and many invertebrate animals are included in this list. No single disinfectant destroys them all. It is up to the applicant to decide what is the pathogen of most concern, and how it is to be reduced or eliminated. -
Phenol Red Solution, 1.0% Alcoholic MSDS # 523.00
Material Safety Data Sheet Page 1 of 2 Phenol Red Solution, 1.0% Alcoholic MSDS # 523.00 Section 1: Product and Company Identification Phenol Red Solution, 1.0% Alcoholic Synonyms/General Names: N/A Product Use: For educational use only Manufacturer: Columbus Chemical Industries, Inc., Columbus, WI 53925. 24 Hour Emergency Information Telephone Numbers CHEMTREC (USA): 800-424-9300 CANUTEC (Canada): 613-424-6666 ScholAR Chemistry; 5100 W. Henrietta Rd, Rochester, NY 14586; (866) 260-0501; www.Scholarchemistry.com Section 2: Hazards Identification Red to orange color liquid, mild odor. HMIS (0 to 4) Health 1 WARNING! Alcohol based solution, flammable liquid and moderately toxic by ingestion. Fire Hazard 3 Flammable liquid, keep away from all ignition sources. Reactivity 0 Target organs: Central nervous system, liver, kidneys. This material is considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200). Section 3: Composition / Information on Ingredients Phenol Red, sodium salt (3447-61-1), 1%. Isopropyl Alcohol (67-63-0), 49.5%. Water (7732-18-5), 49.5%. Section 4: First Aid Measures Always seek professional medical attention after first aid measures are provided. Eyes: Immediately flush eyes with excess water for 15 minutes, lifting lower and upper eyelids occasionally. Skin: Immediately flush skin with excess water for 15 minutes while removing contaminated clothing. Ingestion: Call Poison Control immediately. Aspiration hazard. Rinse mouth with cold water. Give victim 1-2 tbsp of activated charcoal mixed with 8 oz water. Inhalation: Remove to fresh air. If not breathing, give artificial respiration. Section 5: Fire Fighting Measures Class IB Flammable Liquid. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Components of a Vaccine
Components of a vaccine Vaccines include a variety of ingredients including antigens, stabilizers, adjuvants, antibiotics, and preservatives. They may also contain residual by-products from the production process. Knowing precisely what is in each vaccine can be helpful when investigating adverse events following immunization (AEFIs) and for choosing alternative products for those who have allergies or have had an adverse event known or suspected to be related to a vaccine component. Antigens Antigens are the components derived from the structure of disease-causing organisms, which are recognized as 'foreign' by the immune system and trigger a protective immune response to the vaccine. You have already learned about antigens. Click here if you want to review the chapter on antigens. Stabilizers Stabilizers are used to help the vaccine maintain its effectiveness during storage. Vaccine stability is essential, particularly where the cold chain is unreliable. Instability can cause loss of antigenicity and decreased infectivity of LAV. Factors affecting stability are temperature and acidity or alkalinity of the vaccine (pH). Bacterial vaccines can become unstable due to hydrolysis and aggregation of protein and carbohydrate molecules. Stabilizing agents include MgCl2 (for OPV), MgSO4 (for measles), lactose- sorbitol and sorbitol-gelatine. Adjuvants Adjuvants are added to vaccines to stimulate the production of antibodies against the vaccine to make it more effective. Aluminium salts example Adjuvants have been used for decades to improve the immune response to vaccine antigens, most often in inactivated (killed) vaccines. In conventional vaccines, adding adjuvants into vaccine formulations is aimed at enhancing, accelerating and prolonging the specific immune response to vaccine antigens. -
A New Disinfectant
J Clin Pathol: first published as 10.1136/jcp.19.4.318 on 1 July 1966. Downloaded from J. clin. Path. (1966), 19, 318 A new disinfectant PHILIP W. ROSS From the Department of Bacteriology, University of Edinburgh SYNOPSIS Qualitative and quantitative tests have been carried out to assess the value of Cidexl, a glutaraldehyde solution, as a disinfectant. Most of the tests were qualitative and were carried out in conditions as closely resembling those found in hospital practice as possible. Recently used anaesthetic equipment, catheters, and a cysto- scope, which had been artificially contaminated with suspensions of Staph. aureus, Ps. pyocyanea, and Esch. coli, were used in the tests. The results show Cidex to be a useful disinfectant with a valuable potential in disinfecting hospital articles which, due to their perishable nature or the fragility of component parts, cannot be treated by physical means. This paper presents results of several tests done on The present test is simple, easily reproducible, uses Cidex, an activated glutaraldehyde solution, to pathogens commonly associated with hospital cross- assess its effectiveness as a disinfecting agent. Pre- infection, and includes testing the effect of organic matter vious work by Pepper and Chandler (1963) has on the system. shown it to have a sporicidal effect and Borick, MATERIALS Dondershine, and Chandler (1964) have published details of work done on its viricidal properties. The pathogens Ps. pyocyanea, Esch. coli, and Staph. not been examined in the aureus, phage type 80/81, were used. These aspects have http://jcp.bmj.com/ present study. The purpose here is to assess the A cystoscope and four Jaques catheters were tested ability of this agent to kill organisms which cause after being artificially contaminated, and an anaesthetic in hospital cross-infection, notably mask, 31 in. -
The Use of Povidone Iodine Nasal Spray and Mouthwash During the Current COVID-19 Pandemic May Protect Healthcare Workers and Reduce Cross Infection
March 27, 2020 The use of Povidone Iodine nasal spray and mouthwash during the current COVID-19 pandemic may protect healthcare workers and reduce cross infection. J Kirk-Bayley MRCP FRCA EDIC FFICM, Consultant Intensivist & Anaesthetist, Royal Surrey County Hospital S Challacombe, PhD, FRCPath, FDSRCS, FMedSci, DSc(h.c), FKC, Martin Rushton Professor of Oral Medicine, KCL VS Sunkaraneni LLM FRCS(2019), Consultant Rhinologist, Royal Surrey County Hospital J Combes FDS FRCS (OMFS), Lt Col RAMC, Consultant Advisor (ARMY) in OMFS, Defence Medical Services Abstract In late 2019 a novel coronavirus, SARS-CoV-2 causing Coronavirus disease 2019 (COVID-19) appeared in Wuhan China, and on 11th March 2020 the World Health Organisation declared it to have developed pandemic status. Povidone-iodine (PVP-I) has a better anti-viral activity than other antiseptics, and has already been proven to be an effective virucide in vitro against severe acute respiratory syndrome and Middle East respiratory syndrome coronaviruses (SARS-CoV and MERS- CoV). Povidone iodine has been shown to be a safe therapy when inhaled nasally or gargled. We propose that a protocolised nasal inhalation and oropharyngeal wash of PVP-I should be used in the current COVID-19 pandemic to limit the spread of SARS-CoV-2 from patients to healthcare workers (and vice versa) and thus reduce the incidence of COVID-19. There should be regular use in patients with COVID-19 to limit upper respiratory SARS-CoV-2 contamination, but also use by healthcare workers prior to treating COVID 19 patients or performing procedures in and around the mouth/ nose during the pandemic, regardless of the COVID 19 status of the patient.