MANGANESE & HEALTH: A BALANCE OF STORIES
|
|
- Harry Charles
- 6 years ago
- Views:
Transcription
1 MANGANESE & HEALTH: A BALANCE OF STORIES November
2 Overview 2. Analysis of Literature on Carcinogenicity & Mutagenicity 1. Uses of inorganic Mn substances 3. Research to better understand Carcinogenicity & Mutagenicity potential 5. Research on reprotoxicity to put an end to the story 4. Reprotoxicity & Authorities understanding November2014 2
3 Uses of Inorganic Mn-based substances Introduction: One vital feature of manganese, which is not widely appreciated, is its role as an essential element. Outside this role are other unique properties necessary for the production of numerous applications which impact on our daily lives as consumers. Steel making: Mn s ability to combine with sulphur and its powerful deoxidation capacity make it a vital component of steel, giving it the necessary hardness and strength Portal Batteries Manganese in the form of manganese dioxide functions as an electron acceptor in alkaline batteries Aluminum beverage cans: Manganese plays an essential role in the absorption of impurities which then increases resistance against corrosion in aluminum cans Fertilizers: Manganese is a micronutrient necessary for plant metabolism. In high ph soils, organic soils, and sandy soils Mn- containing fertilizers are required IMnI 3
4 2. Analysis of literature on Carcinogenicity & Mutagenicity The reviewed published literature on carcinogenicity & genotoxicity potential of inorganic Mn (????) Concluded that: Available occupational & environmental epidemiological evidence is equivocal as to whether exposure to inorganic Mn is associated with risk to cancer There is insufficient evidence to indicate that inorganic Mn exposure produces cancer in animals or humans
5 3. Research to Investigate Carcinogenicity & Mutagenicity potential Of Inorganic Mn substances MnCl2 (1) Study: Ames Test Bacterial reverse mutation assay (Ames test) Looks at gene mutation using Rat Liver cells Conducted to OECD Guideline 471; EU Method B.13/14, US EPA (TSCA) and Japanese Regulatory Authorities guidelines (METI) Results No toxicological increase in the frequency of reverse mutation Non- mutagenic
6 3. Research to Investigate Carcinogenicity & Mutagenicity potential Of Inorganic Mn substances (2) Study: Mouse Lymphoma Gene mutation To OECD Guideline 476 & GLP guidelines Results: Did not induce any dose related increase in mutant frequency It was considered to be nonmutagenic
7 3. Research to Investigate Carcinogenicity & Mutagenicity potential Of Inorganic Mn substances (3) Study: Chromosome aberration Mammalian chromosome aberration (cultured human lymphocytes) OECD Guideline 473 & GLP Results: Doses were high enough to cause toxicity to the lymphocytes but did not induce cell aberration Non-clastogenic
8 3. Research to Investigate Carcinogenicity & Mutagenicity potential Of Inorganic Mn substances (4) *Study: In vivo Micronucleus Mammalian Erythrocytes OECD Guideline 474 & GLP Results: Genotoxicity: negative Female toxicity: no effects Animal no. 23 showed hunched posture at 1 hour post dose observation on Day 1 of the study All other animals were found to be normal throughout the study *Published literature - Streicker MA (2009)
9 Carcinogenicity & Mutagenicity Results & Conclusions The suite of studies conducted used cells from different genus's rat, mouse, human... The research also investigated different parts of cells e.g. nucleus, chromosome... All studies were conducted to internationally recognised guidelines and sponsored by different organisations The doses were high enough to induce toxicity but in all cases mutagenicity and carcinogenicity effects were not seen Manganese is NOT a Carcinogen or a Mutagen IMnI 9
10 4. Reprotoxicity & authorities understanding The EU Scientific Committee on Occupational Exposure Limits (SCOEL) commented that that there was little evidence for reproductive or developmental toxicity of inhaled manganese The US Agency for Toxic Substances and Disease Registry (ATSDR) reported that impaired sexual function in men may be one of the earliest clinical manifestations of Mn toxicity... Health Canada s website states that a number of studies have shown that exposure to Mn can cause deleterious effects on the male reproductive system IMnI 10
11 5. Research on reprotoxicity to put an end to the story Group 1 Group 2 Group 3 Group 4 Animals F0 28M+28F F1 26M+26F F0 28M+28F F F F0 28M+28F F1 24M+24F F0 28M+28F F1 25M+25F F0 Target dose (µg/l) Dose period Daily dose duration* Frequency 0 (air) F0 Approximately 17 weeks F1 Approximately 17 weeks 6 hours Daily F1 F2
12 Reproductive toxicity Results & conclusions No changes in reproductive organ weights & histology, No effects on sperm quality & quantity, No effects on oestrous cycles, fertility or duration of gestation No decrease in libido for both males & females # of implantation sites, birth weights, litter sizes were normal... Manganese is NOT a REPROTOXICANT Metal Bulletin 12
13 Take home messages Industry/employers should know the intrinsic properties of the substances they manufacture and/or use Scientists should invest in good and sound science minimizing any potential confounders Regulators should use the latest science and understand information from different kinds of research to make good decisions Workers, communities, NGO s and unions should have a balance of stories to enable then draw their own conclusions Inorganic manganese based substances are NOT carcinogenic, mutagenic or toxic to reproduction Now Go! Tell This Story! IMnI 13
14 Thank you! Happy to answer any questions!
VICH GL23: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing
6 November 2014 EMA/CVMP/VICH/526/2000 Committee for Medicinal Products for Veterinary Use (CVMP) VICH GL23: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing
More informationThe Comet Assay Tails of the (Un)expected
The Comet Assay Tails of the (Un)expected Use of the in vivo comet assay in pharmaceutical development Bas-jan van der Leede Janssen R&D Johnson & Johnson Pharmaceutical Companies Discovery Sciences Genetic
More information5.17 PENTHIOPYRAD (253)
Penthiopyrad 189 5.17 PENTHIOPYRAD (253) TOXICOLOGY Penthiopyrad is the International Organization for Standardization (ISO) approved name for N-[2- (1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide
More informationGenotoxicity Testing Strategies: application of the EFSA SC opinion to different legal frameworks in the food and feed area
Genotoxicity Testing Strategies: application of the EFSA SC opinion to different legal frameworks in the food and feed area Juan Manuel Parra Morte. Pesticides Unit. EFSA. 19th Annual Conference of the
More informationRe: Evaluation of Silver Substances under Regulation 528/2012
Sliver Task Forte Silver Task Force North America 1150 13th Street, NW, Suite 1000 Washington, DC. 20036 Direct: (202) 828-8966 Fax: (202) 872-0745 E-Mail: etesch@tsgusa.com European Chemicals Agency Annankatu
More informationGenotoxicity of formaldehyde in vitro and in vivo. Günter Speit
Genotoxicity of formaldehyde in vitro and in vivo Günter Speit Universität Ulm Institut für Humangenetik D-89069 Ulm (Germany) guenter.speit@uni-ulm.de CEFIC-2012 Günter Speit 1 Genotoxicity of formaldehyde
More informationExplanatory note. On an opinion proposing harmonised classification and labelling at EU level of. glyphosate (ISO); N-(phosphonomethyl)glycine
Explanatory note On an opinion proposing harmonised classification and labelling at EU level of glyphosate (ISO); N-(phosphonomethyl)glycine EC Number: 213-997-4 CAS Number: 1071-83-6 This note has been
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationSULFURIC ACID ICSC: 0362 PREVENTION
SULFURIC ACID ICSC: 0362 Date of Peer Review: February 2000 Sulfuric acid 100% Oil of vitriol CAS # 7664-93-9 H 2SO 4 RTECS # WS5600000 Molecular mass: 98.1 UN # 1830 EC Annex 1 Index 016-020-00-8 # EC/EINECS
More information(Z)-1-Chloro-2,3,3,3-tetrafluoropropene (2017)
WORKPLACE ENVIRONMENTAL EXPOSURE LEVEL (Z)-1-Chloro-2,3,3,3-tetrafluoropropene (2017) I. IDENTIFICATION Chemical Name: (Z)-1-Chloro-2,3,3,3-tetrafluoropropene Synonyms: HCFO-1224yd(Z) CAS Number: 111512-60-8
More informationGlyphosate Hazard and Risk Assessment: A Comparison of the Approaches of Two International Agencies
Glyphosate Hazard and Risk Assessment: A Comparison of the Approaches of Two International Agencies David A. Eastmond Environmental Toxicology Graduate Program University of California, Riverside Glyphosate
More informationDevelopment of safe levels of elemental impurities
Development of safe levels of elemental impurities ICH Q3D MASSET Dominique Head of Pharmaceutical Quality Non Clinical and Viral Safety Department Evaluation division 5 april 2016 EMA London Safe Levels
More informationRisk Assessment Report on Tris (nonylphenyl)phosphite (TNPP)
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Public Health and Risk Assessment C7 - Risk assessment SCIENTIFIC COMMITTEE ON HEALTH AND ENVIRONMENTAL RISKS SCHER
More informationGPS Product Safety Summary
Document Number: GPSSR 20 15 MAGNESIUM CHLORIDE GENERAL STATEMENT GPS summary is intended to provide a general overview of the chemical substances in context of ICCA Global Product Strategy. The information
More information1 OJ L 354, , p OJ L 80, , p. 19.
Call for scientific and technical data on the permitted food additives sulphur dioxide (E 220), sodium sulphite (E 221), sodium bisulphite (E 222), sodium metabisulphite (E 223), potassium metabisulphite
More information2,5-DICHLOROBENZOIC ACID METHYLESTER
2,5-DICHLOROBENZOIC ACID METHYLESTER List of II studies which were considered as relied upon for the evaluation with a view to I inclusion and for which the main submitter has claimed data protection Version
More informationTo: Recipients of JACC 42. HV/mls/JACC 42 corrigendum Brussels, 15 December 2004
EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS AISBL To: Recipients of JACC 42 HV/mls/JACC 42 corrigendum Brussels, 15 December 2004 Dear Sir or Madam, Corrigenda to JACC No. 42 - Tetrafluoroethylene
More informationTable of Validated and Accepted Alternative Methods
1 de 8 25/10/2011 13:02 Non-animal Methods for Toxicity Testing Table of Validated and Accepted Alternative Methods Last Updated: September 27, 2011 Validation & Status of Alternative Test Methods & Testing
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationDichlorvos DICHLORVOS (025)
Dichlorvos 63 5.7 DICHLORVOS (025) TOXICOLOGY Dichlorvos is the International Organization for Standardization (ISO) approved common name for 2,2-dichlorovinyl dimethyl phosphate (International Union of
More informationMATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY Material Manufacturer Distributor Telmisartan and Hydrochlorothiazide Tablets USP 40 mg/12.5 mg; 80 mg/12.5 mg and 80 mg/25
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 Emergency telephone number:
More informationHYDROGEN PEROXIDE HUMAN HEALTH EFFECTS. CAS No.: EINECS No.: REPORT VERSION: Draft of 24 April 2001
EUROPEAN COMMISSION DIRECTORATE-GENERAL HEALTH AND CONSUMER PROTECTION Directorate C - Scientific Opinions Unit C2 - Management of Scientific Committees; scientific co-operation and networks Scientific
More informationSection 5.3: Preclinical safety data
Section 5.3: Preclinical safety data SmPC training presentation Note: for full information refer to the European Commission s Guideline on summary of product characteristics (SmPC) SmPC Advisory Group
More informationMATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY Material Manufacturer Distributor Irbesartan Tablets USP 75 mg, 150 mg and 300 mg Lupin Limited Pithampur (M.P.) - 454 775
More informationJustification of classification of boron compounds in European Union
Justification of classification of boron compounds in European Union Boguslaw Baranski, Beata Peczkowska Bureau for Chemical Substances 30/34 Dowborczyków Street 90-019 Lódz, Poland Boric acid and borates
More informationEUROPEAN COMMISSION DG Employment, Social Affairs and Inclusion. The Advisory Committee on Safety and Health at Work. Opinion
EUROPEAN COMMISSION DG Employment, Social Affairs and Inclusion Employment and Social Legislation, Social Dialogue Health, Safety and Hygiene at Work Doc.1893-EN The Advisory Committee on Safety and Health
More informationMATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY Material Manufacturer Distributor Irbesartan and hydrochlorothiazide Tablets USP 150 mg/12.5 mg, 300 mg/12.5 mg and 300 mg/25
More informationMaria João Silva H. Louro 1, T. Borges 2, J. Lavinha 1, J.M. Albuquerque 1
Maria João Silva H. Louro 1, T. Borges 2, J. Lavinha 1, J.M. Albuquerque 1 1 National Institute of Health Dr. Ricardo Jorge 2 General-Directorate of Health, Lisbon, Portugal Venice.,10-03-2015 The number
More informationLUPIN LIMITED SAFETY DATA SHEET. Section 1: Identification. Memantine Hydrochloride Extended Release Capsules 7 mg, 14 mg, 21 mg and 28 mg
LUPIN LIMITED SAFETY DATA SHEET Section 1: Identification Section 1, Identification Material Manufacturer Distributor Memantine Hydrochloride Extended Release Capsules 7 mg, 14 mg, 21 mg and 28 mg Lupin
More informationComments CLH proposal Cadmium hydroxide
1 Comments CLH proposal Cadmium hydroxide GENERAL COMMENTS: The International Cadmium association (ICdA) welcomes the opportunity to provide its contribution to the public consultation on the proposed
More information5.36 THIOPHANATE-METHYL (077)
391 5.36 THIOPHANATE-METHYL (077) TOXICOLOGY is the International Organization for Standardization (ISO) approved common name for dimethyl 4,4 -(o-phenylene)bis(3-thioallophanate) (International Union
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationPesticide Product Labels What the label says.and Why. Dr. Jeff Birk BASF Corporation Regulatory Manager
Pesticide Product Labels What the label says.and Why Dr. Jeff Birk BASF Corporation Regulatory Manager Regulation of Pesticides The pesticide industry is regulated by the USEPA. The pesticide industry
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 5 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationNonclinical Safety Evaluation of Inhalation Drug Products
Nonclinical Safety Evaluation of Inhalation Drug Products February 13, 2002 Life Science Research Organization Bethesda, Maryland Luqi Pei, Ph.D. Division of Pulmonary and Allergy Drug Products Center
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationTest guidelines and guidance documents in the field of plant protection products
Test guidelines and guidance documents in the field of plant protection products BfR background information No. 032/2015 of 3 August 2015 The legislator has stipulated binding rules determining which test
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationLecture -2- Environmental Biotechnology
Lecture -2-1-General Bioassay in pollution Monitoring 1 1 Genotoxicity test At the early testing stages, the genotoxicity assays for predicting potential heritable germ cell damage are the same as used
More informationECHA Committee for Risk Assessment: Evaluation of the Classification and Labelling of Glyphosate
ECHA Committee for Risk Assessment: Evaluation of the Classification and Labelling of Glyphosate Tim Bowmer, Committee Chairman Ari Karjalainen, Dossier Manager for Glyphosate 10 May 2017 1 Established
More informationLUPIN LIMITED SAFETY DATA SHEET
LUPIN LIMITED SAFETY DATA SHEET Section 1: Identification Section 1, Identification Material Manufacturer Distributor Diclofenac Sodium Topical Solution 1.5% w/w Lupin Limited Pithampur (M.P.) 454 775
More informationThe effect of REACH implementation on genotoxicity and carcinogenicity testing Jan van Benthem
The effect of REACH implementation on genotoxicity and carcinogenicity testing Jan van Benthem National Institute for Public Health and the Environment Laboratory for Health Protection Research Bilthoven
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationGPS Safety Summary. 2-Phenoxyethyl acrylate
GPS Safety Summary Substance Name: 2-Phenoxyethyl Acrylate 1. General Statement 2-Phenoxyethyl acrylate is a monofunctional acrylic monomer which can be polymerised by free radicals. In particular, 2-Phenoxyethyl
More informationalternative short-chain fluorinated product technology
The extensive toxicology data behind alternative short-chain fluorinated product technology SOT RASS-MISS Webinar 9 December 2015 Robert C. Buck, PhD Technical Fellow The Chemours Company Wilmington, Delaware,
More informationACTIVITIES DEVELOPED AND PROMOTED BY WHO
IFCS FORUM V SIDE EVENT ON HEAVY METALS Hosted by the Swiss Confederation 23 September 2006 Budapest, Hungary Health and environmental concerns associated with heavy metals: Global needs for further action?
More informationComparison of different genotoxicity tests in vitro for assessment of surface water quality E. Dopp, J. Richard, S. Zander-Hauck
Comparison of different genotoxicity tests in vitro for assessment of surface water quality E. Dopp, J. Richard, S. Zander-Hauck 7th BioDetector Conference (November 7 8, 2013) 1 Introduction Increased
More informationTOXICITY DATA (continued): KETOCONAZOLE (continued): TDLo (Oral-Rat) 1760 mg/kg: female 1-21 day(s) after conception: Reproductive: Maternal Effects: other effects; Fertility: post-implantation mortality
More informationCycloxydim CYCLOXYDIM (179)
Cycloxydim 125 5.9 CYCLOXYDIM (179) TOXICOLOGY Cycloxydim is the ISO approved name for (5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)- thian-3-yl]cyclohex-2-en-1-one (IUPAC). The CAS chemical name
More informationConsiderations in Toxicology Study Design and Interpretation: An Overview Gradient Corporation: Lewis, AS; Beyer, LA; Langlois, CJ; Yu, CJ; Wait, AD
Considerations in Toxicology Study Design and Interpretation: An Overview Gradient Corporation: Lewis, AS; Beyer, LA; Langlois, CJ; Yu, CJ; Wait, AD Introduction The use of animal data to evaluate the
More informationThe Impact of REACH on the Hazard Communications of US substances. Raymond M. David, Ph.D., DABT Manager, Toxicology BASF Corporation
The Impact of REACH on the Hazard Communications of US substances Raymond M. David, Ph.D., DABT Manager, Toxicology BASF Corporation Overview Status of REACH registrations Phase 1 substances (testing,
More informationCAS-No. EC-No. Index-No. Concentration Ampicillin
SIGMA-ALDRICH Material Safety Data Sheet Version 3.0 Revision Date 12/25/2008 Print Date 04/23/2009 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Ampicillin Product Number : A1593 Brand : Sigma-Aldrich
More informationTRIS (NONYLPHENYL) PHOSPHITE SUMMARY RISK ASSESSMENT REPORT
TRIS (NONYLPHENYL) PHOSPHITE CAS-No.: 26523-78-4 EINECS-No.: 247-759-6 SUMMARY RISK ASSESSMENT REPORT Final report, 2007 France Rapporteur for the risk assessment of tris(nonylphenyl) phosphite is the
More informationLUPIN LIMITED SAFETY DATA SHEET. Section 1: Identification. Abacavir Sulfate, Lamivudine and Zidovudine Tablets 300 mg, 150 mg and 300 mg
LUPIN LIMITED SAFETY DATA SHEET Section 1: Identification Section 1, Identification Material Manufacturer Distributor Abacavir Sulfate, Lamivudine and Zidovudine Tablets 300 mg, 150 mg and 300 mg Lupin
More informationGeneral introductory remarks
JAPANESE RISK ASSESSMENT ON ANTIMONY AND ITS COMPOUNDS - SUGGESTIONS I2A ON MUTAGENICITY/GENOTOXICITY, REPRODUCTIVE TOXICITY, CARCINOGENICITY AND OEL VALUE- (JANUARY 2013) Abbreviations: ATO = diantimony
More informationRenaissance Lime Putty
Updated 1 July 2016 Material Safety Data Sheet Slaked Lime Putty Calcium Dihydroxide Ca(OH)2 CAS # 1305-62- 0 Section 1. Company Identification Renaissance Lime Putty 416 Lafayette Street Salem, MA 01970
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationRisk Assessment Report on. Bis(hydroxylammonium)sulfate. CAS No.: EINECS no.:
Scientific Committee on Health and Environmental Risks SCHER Risk Assessment Report on Bis(hydroxylammonium)sulfate CAS No.: 10039-54-0 EINECS no.: 233-118-8 The SCHER adopted this opinion at its 21 st
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 7 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationCOCAM 3, October 2012 SIDS INITIAL ASSESSMENT PROFILE
SIDS INITIAL ASSESSMENT PROFILE Category Name Aryl Substituted Dialkyl Peroxides CAS No(s). 80-43-3 25155-25-3 Chemical Name(s) 1,1'-(Dioxydipropane-2,2-diyl)dibenzene (DCUP) [1,3(or 1,4)-Phenylenebis(1-methylethylidene)]bis[tert-butyl]
More informationDr. Josef Schlatter Member of the Scientific Committee and EFSA s WG on Novel Foods
Guidance on Novel Foods From Animal Toxicity Studies to Safe Levels of Intake in Humans Dr. Josef Schlatter Member of the Scientific Committee and EFSA s WG on Novel Foods Info-session 06 March 2017 Parma
More informationAssessment of the Health Risks from the Use of Metallic Nickel (CAS No ) in Toys
Scientific Committee on Health and Environmental Risks SCHER Assessment of the Health Risks from the Use of Metallic Nickel (CAS No 7440-02-0) in Toys The SCHER adopted this opinion at its 17 th plenary
More informationLUPIN LIMITED SAFETY DATA SHEET. Section 1: Identification. Repaglinide and Metformin Hydrochloride Tablets 1 mg/500 mg and 2 mg/500 mg
LUPIN LIMITED SAFETY DATA SHEET Section 1: Identification Section 1, Identification Material Manufacturer Distributor Repaglinide and Metformin Hydrochloride Tablets 1 mg/500 mg and 2 mg/500 mg Lupin Limited
More informationOutcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology
TECHNICAL REPORT APPROVED: 25 July 2016 Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology Abstract European Food Safety Authority This technical report reflects
More information5.3 AZINPHOS METHYL (002)
5.3 AZINPHOS METHYL (002) TOXICOLOGY Azinphos-methyl is the ISO approved common name for S-3,4-dihydro-4-oxo-1,2,3-benzotriazin-3- ylmethyl O,O-dimethyl phosphorodithioate (IUPAC) or O,O-dimethyl S-[(4-oxo-1,2,3-benzotriazin-
More informationPEST MANAGEMENT REGULATORY AGENCY DATA REQUIREMENTS FOR. USE SITE CATEGORY (USC # 8): Livestock for Food - TGAI
0 Index R 1 Label R 2 Chemistry requirements for the registration of a technical grade of active ingredient (TGAI) or an integrated system product. 2.1 Applicant s Name and Office Address R 2.2 Manufacturer
More information5.15 HEXYTHIAZOX (176)
Hexythiazox 225 5.15 HEXYTHIAZOX (176) TOXICOLOGY Hexythiazox is the ISO approved name for (trans-5-(4-chlorophenyl)-n-cyclohexyl-4-methyl-2-oxo- 3-thiazolidine-carboxamide (CAS No. 78587-05-0). Hexythiazox
More informationHEALTH CONSULTATION. Tom Lea Park EL PASO COUNTY METAL SURVEY EL PASO, EL PASO COUNTY, TEXAS EPA FACILITY ID: TX
HEALTH CONSULTATION Tom Lea Park EL PASO COUNTY METAL SURVEY EL PASO, EL PASO COUNTY, TEXAS EPA FACILITY ID: TX0000605388 September 6, 2002 Prepared by: The Texas Department of Health Under a Cooperative
More informationPesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009
Pesticide risk assessment: changes and perspectives for mammalian toxicology in the new EC regulation 1107/2009 M.Tiramani Pesticide Risk Assessment Peer Review (PRAPeR) Mammalian toxicology New Pesticide
More informationAssessment of Reproductive Toxicity under REACH July Walter Aulmann
Assessment of Reproductive Toxicity under REACH July 2012 Walter Aulmann Position Paper Aulmann (2012), Assessment of reproductive toxicity under REACH. Regul. Toxicol. Pharmacol. 63 (2012) 286-290 Toxic
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 5 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationRead-across illustrative example
Part 2 Example 1 Analogue approach: similarity based on breakdown products Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland Tel. +58 9 686180 Fax +58 9 68618210 echa.europa.eu 2 Example 1 DISCLAIMER
More informationMETHACRYLIC ACID CAS N :
FOREWORD INTRODUCTION CAS N : 79-41-4 UNEP PUBLICATIONS SIDS INITIAL ASSESSMENT PROFILE CAS No. 79-41-4 Chemical Name Methacrylic acid Structural Formula CH 2 =CH(CH 3 )-COOH RECOMMENDATIONS The chemical
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationInternational Safety Assessment of Sweeteners
ILSI SEA Region Seminar on Uses and Safety of Sweeteners (May 2013) http://www.ilsi.org/sea_region/pages/vieweventdetails.aspx?webid=4d540914-eeb6-40e4-89eb- 0B73BA3D76C1&ListId=478BE3CB-581B-4BA2-A280-8E00CCB26F9C&ItemID=73
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationNutritional and Toxicological Aspects of Manganese Intake. Annette Santamaria, PhD, MPH, DABT ENVIRON International Corporation May 6, 2008
Nutritional and Toxicological Aspects of Manganese Intake Annette Santamaria, PhD, MPH, DABT ENVIRON International Corporation May 6, 2008 Overview Sources of Manganese Exposure Essentiality and Toxicity
More information(Text with EEA relevance) Having regard to the opinion of the European Economic and Social Committee ( 1 ),
27.12.2017 Official Journal of the European Union L 345/87 DIRECTIVE (EU) 2017/2398 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2017 amending Directive 2004/37/EC on the protection of
More informationToxStrategies, Inc. and Summit Toxicology
Deborah Proctor Chad Thompson, Mark Harris, Mina Suh, Laurie Haws, Chris Kirman and Sean Hays ToxStrategies, Inc. and Summit Toxicology November 2012 Research Project funded by the Cr 6 Panel of the American
More informationMATERIAL SAFETY DATA SHEET
Page 1 of 5 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone
More informationZoledronic Acid Accord 4 mg/5 ml
Zoledronic Acid Accord 4 mg/5 ml Material Safety Data Sheet 1. Product and Company Identification Product name: Use: Company information Enquiries: Synonyms: Zoledronic Acid Accord 4 mg/5 ml concentrate
More informationDraft agreed by Excipients Drafting group 16 June Adopted by CHMP for release for consultation 23 July 2015
1 2 3 23 July 2015 EMA/CHMP/619104/2013 Committee for Human Medicinal Products (CHMP) 4 5 6 7 8 Questions and answers on boric acid in the context of the revision of the guideline on Excipients in the
More informationPerfluorooctanesulfonic acid (PFOS) and Perfluorooctanoic acid (PFOA) What are PFOS and PFOA?
Perfluorooctanesulfonic acid (PFOS) and Perfluorooctanoic acid (PFOA) What are PFOS and PFOA? PFOS and PFOA belong to a family of perfluorochemicals (PFCs), and are human-made chemicals that do not occur
More informationEuropean Food Safety Authority (EFSA)
TECHNICAL REPORT APPROVED: 24 July 2018 doi:10.2903/sp.efsa.2018.en-1470 Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for iodosulfuron and prosulfuron
More informationEuropean Food Safety Authority (EFSA)
STATEMENT ADOPTED: 5 July 2018 doi: 10.2903/j.efsa.2018.5383 Statement on the impact of the harmonised classification on the conclusion on the peer review of the pesticide risk assessment of the active
More informationProduct Safety Summary for 12-Aminododecanoic Acid
SUBSTANCE NAME 12-Aminododecanoic acid 12-Aminolauric Acid omega-aminolauric acid ADA GENERAL STATEMENT 12-Aminododecanoic acid is a white solid and almost odorless compound. At 20 C, the relative density
More informationAPPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELs FOR 1-BROMOPROPANE (1-BP)
1 (10) Helsinki, 09 September 2016 RAC/38/2016/09 rev 1 Final APPLICATION FOR AUTHORISATION: ESTABLISHING REFERENCE DNELs FOR 1-BROMOPROPANE (1-BP) Background At the 22 nd meeting of the Committee for
More informationSIAM 18, April 2004 SIDS INITIAL ASSESSMENT PROFILE SUMMARY CONCLUSIONS OF THE SIAR
SIDS INITIAL ASSESSMENT PROFILE CAS No. 1306-19-0 & 7440-43-9 Chemical Name Cadmium oxide & Cadmium metal Structural Formula CdO & Cd Category/Analogue Rationale SUMMARY CONCLUSIONS OF THE SIAR The main
More informationSafety of Allura Red AC in feed for cats and dogs
SCIENTIFIC OPINION ADOPTED: 20 October 2015 PUBLISHED: 10 November 2015 doi:10.2903/j.efsa.2015.4270 Safety of Allura Red AC in feed for cats and dogs EFSA Panel on Additives and Products or Substances
More informationHOW GOOD ARE VALIDATED METHODS TO PREDICT TOXICITY OF DIFFERENT TYPES OF SUBSTANCES AND PRODUCTS?
HOW GOOD ARE VALIDATED METHODS TO PREDICT TOXICITY OF DIFFERENT TYPES OF SUBSTANCES AND PRODUCTS? VERA ROGIERS Dept. Toxicology Vrije Universiteit Brussel Brussels, Belgium LAYOUT OF THE TALK CURRENT STATUS
More informationINTERNATIONAL CONCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE Q3D(R1)
INTERNATIONAL CONCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GUIDELINE FOR ELEMENTAL IMPURITIES (R1) Draft version Endorsed on 18 May 2018
More informationOfficial Journal of the European Union
1.6.2016 L 144/27 COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
More informationAddendum to the 12th Report on Carcinogens
Addendum to the 12th Report on Carcinogens Published by the U.S. Department of Health and Human Services, National Toxicology Program The twelfth edition of the National Toxicology Program (NTP) Report
More informationPEST MANAGEMENT REGULATORY AGENCY DATA REQUIREMENTS FOR. USE SITE CATEGORY (USC # 5): Greenhouse Food Crops - TGAI
0 Index R 1 Label R 2 Chemistry requirements for the registration of a technical grade of active ingredient (TGAI) or an integrated system product 2.1 Applicant s Name and Office Address R 2.2 Manufacturer
More informationA review of human carcinogens -Part F: Chemical agents and related occupations
A review of human carcinogens -Part F: Chemical agents and related occupations In October 2009, 23 scientists from 6 countries met at the International Agency for Research on Cancer (IARC) to re-assess
More information5.24 TRIAZOLE FUNGICIDE METABOLITES
Triazole metabolites 355 5.24 TRIAZOLE FUNGICIDE METABOLITES TOXICOLOGY 1,2,4-Triazole, triazole alanine, triazole acetic acid, triazole pyruvic acid and triazole lactic acid are the common metabolites
More informationSafety Data Sheet. Recommended Use of the Chemical and Restrictions On Use: Pharmaceutical Product, Opiod Analgesic
Safety Data Sheet 1. IDENTIFICATION Products: Oxycodone Hydrochloride Tablets 5mg Oxycodone Hydrochloride Tablets 10mg Recommended Use of the Chemical and Restrictions On Use: Pharmaceutical Product, Opiod
More information