PMTC Knowledge Day 2017 August 31 st Cleaning validation hot topics. THOMAS ALTMANN. Global Technical Manager ECOLAB LIFE SCIENCES RD&E.
|
|
- Claire Helena Hensley
- 5 years ago
- Views:
Transcription
1 PMTC Knowledge Day 2017 August 31 st 2017 Cleaning validation hot topics THOMAS ALTMANN. Global Technical Manager ECOLAB LIFE SCIENCES RD&E.
2 Cleaning validation hot topics. Overview Limit setting PDE approach for detergents? Visually clean Cleanability
3 Limit setting. Overview Limit discussion is ongoing since 1984 Practical / Achievable / Verifiable (FDA; PIC/S) Visually clean?
4 Limit setting. FDA recommendation 10 PPM htm PIC/S recommendation < 10 ppm of any product will appear in another product 1/1000 of the normal therapeutic dose < 0.1% of the normal therapeutic dose No residue No quantity of residue should be Remark: cleaning validation limits are set at 1/1000th of the minimum therapeutic dose
5 Limit setting. Limits we find today for APIs. Fixed values (e. g. 10 ppm) Threshold of toxicological concern (TTC) Dose based limits based on: therapeutic dose toxicological dose Analytical possibilities Visually clean? The objective is to scientifically justify why you set particular residual limits. (GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES published in
6 Limit setting. Limits for active ingredients Risk based approach to validation is recommended Guidelines on Good Manufacturing Practices: Validation, Appendix 7: Non-sterile Process Validation. WHO Technical Report Series, No. 992, 2015, Annex 3 (2015; 12 pages) Health-based risk assessment approach (Risk-MaPP, based on ICH Q9) Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
7 Limit setting. ANNEX 15 ANNEX 15
8 Limit setting. Limits for active ingredients - risk-based approach
9 Limit setting. Acute toxcicity LD 50 Single exposure Lethal dose ; 50% of test organisims die Unit declared as mg/kg (bodyweight) Effect should occur within 14 days Lethal animal testing discussion OECD 401 (obsolete) Repeated exposure NOAEL Daily exposure for time period / lifetime No physical effect evident or occurring Units declared as mg/kg (bodyweight) /day Upto date and more applicable study
10 Limit setting. Limits calculated by conventional method and risk-based approach LD 50 and NOAEL values Substance LD 50 Wert [mg/kg] NOAEL [mg/kg(day)] Surfactant 2 > (rat, 90 d, gavage) Henkel 1990/91 Surfactant (HPV SIDS FND Amines Category) Soap component (rat, 90d, oral feed) HPV dossier Soap component 2 >2000 * > 3000 (rat, 2-16w, oral feed) BIBRA, Analogy to caprylic acid NaOH 500 gastric conversion to NaCl uptake negligible compared to food Phosphonate > (rat, 90d, oral feed) OECD SIDS, Analogy to acid Substance LD 50 Wert [mg/kg] NOAEL [mg/kg(day)] Organic Acid (rat, lifetime, drinking water) HPV dossier, analogy to calcium formate Organic Acid (rat, 90d, oral feed) OECD SIDS Phosphoric Acid (rat, 90w, oral feed) JECFA
11 Limit setting. Limits for active ingredients - risk-based approach
12 12 Toxicological Factors.
13 13 Toxicological Factors. ne/2009/10/wc pdf
14 Limit setting. Limits calculated by conventional method and risk-based approach COSA product LD 50 dose [mg/kg bodyweight] DNEL mix [mg/kg bodyweight] DNEL worst case substance [mg/kg bodyweight] COSA CIP COSA CIP COSA CIP COSA CIP COSA CIP COSA CIP COSA DES COSA PUR COSA PUR COSA PUR COSA PUR COSA PUR COSA FOAM COSA FLUX
15 Limit setting. Limits calculated based on acute toxicity (LD 50 ) - conventional method LD 50 -value for mixtures Schweizer formula LD %Substance 1 %Substance 2 %Substance 3... Substance Substance 2 50Substance 3 LD LD LD %Substance(X) = mass content of the component in the preparation [%] Literature: CLP Guideline (EG) No. 1272/2008
16
17 Calculation example.
18 Limit setting. Summary There are different possibilities to calculate limits for cleaning agents Calculated no effect levels based on LD 50 values are very conservative! Fixed / pre-defined levels like 10 ppm or TTC are in the same range as values calculated based on LD 50 values
19 Cleaning validation hot topics Overview Limit setting PDE approach for detergents? Visually clean? Cleanability
20 Coupon 1 Coupon 2 Coupon 3 Coupon 4 Visually clean. VISUAL INSPECTION Station 1 Different material Basic information of construction have a different apperance when visually clean. Operators have to be trained to be Question aware as to.. "What does visually Coupon clean visual look clean? like?" Please evaluate if the coupons (made of different materials) are visually clean. Use your own opinion and experience to judge if a coupon is visually clean or not! Remark: Always wear gloves by handling the coupons! Do not remove coupons out of the tray
21 Visually clean API powder materials Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean ~ 400 µg/100cm² (~4µg/cm²) Frank Buscalferria, Dr. Sabine Lorenzenb, Dr. Michael Schmidt, Dr. Hans-Martin Schwarmd, Dr. Ehrhard Anhalte, Dr. Reinhard Herzoga und Prof. Ronald Zieglera Bestimmung der Sichtbarkeitsgrenzen von pharmazeutischen Feststoffen auf Edelstahloberflächen [Pharm. Ind. 62 Nr. 6 (2007)]
22 1µg/cm² 10µg/cm² Different detergents applied to stainless steel surfaces. Demin water Acid detergent 1 Acid detergent 2 Alkaline + Surfactants Alkaline detergent
23 Visually clean Visibility of detergents. For different COSA product concentrates we can state An amount of 1 µg/cm² can be detected visually Concentrations of 1µg/cm² show spots on surface Concentrations of 10µg/cm² show different appearances (depending on the product applied)
24 Cleaning validation hot topics. Overview Limit setting PDE approach for detergents? Visual clean Cleanability
25 Cleanability.
26 Cleanability studies- examples. Support to decide on which is the right cleaning procedure for specific processes and products. The two most common procedures for the evaluation are: Solubility test Mostly used for tablets and solids or for pre-testing Dipping test Mostly used for ointments or liquids
27 Cleanability studies- examples. Solubility test Is a detergent solution able to dissolve the residue? Physical aspects e.g. is the solution getting more viscous with addition of chemistry Chemical aspects e.g. Is there reaction with the residues and the detergent?
28 Cleanability studies examples. 28 Cleaning recommendation Cleaning evaluation All cleaning recommendation are proposals and based on solubility of residues in the correct chemistries/detergents. Cleaning optimisation in terms of time, temp, mechanical action & final chemical concentration will need to be determined & validated on site.
29 29 Cleanability studies examples. Temperature Concentration
30 Cleaning validation hot topics Thank you for your attention. Any Questions? Please find ECOLAB out in the foyer area.
31 List of abbreviations ADI Acceptable Daily Intake ADE BW DNEL NOAEL NOEL MACO PDE SF TTC UF Acceptable Daily Exposure Body Weight Derived No Effect Level No Observed Adverse Effect Level No Observed Effect Level Maximum Allowable Carry-Over Permitted Daily Exposure (=DNEL*weight adjustment) Safety Factor Threshold of Toxicological Concern Uncertainty Factor
Cleaning validation. Presented by Marc Fini 21 May, 2013
Cleaning validation Presented by Marc Fini 21 May, 2013 What is cleaning validation? Cleaning validation is documented evidence that the cleaning process can effectively and reproducibility clean equipment
More informationToxicological tool. Sarah O Meara, PhD, MSc PharmMed Non-clinical Assessor. GMP Conference 12 th November 2014
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities Toxicological tool Sarah O Meara, PhD, MSc PharmMed
More informationRegarding Establishment of a Uniform Limit in a Positive List System concerning Agricultural Chemicals Residues in Food etc.
Regarding Establishment of a Uniform Limit in a Positive List System concerning Agricultural Chemicals Residues in Food etc. (Final Draft) In introducing a positive list system concerning agricultural
More informationConflict of Interest Disclosure
Conflict of Interest Disclosure I wish to declare a potential conflict of interest, and that I have received direct industry support from the International Life Sciences Institute (ILSI) in relation to
More informationMATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET 1. COMPANY AND PRODUCT IDENTIFICATION DUNCAN ENTERPRISES EMERGENCY TELEPHONE NUMBERS 5673 East Shields Avenue Health Emergency: 559-291-4444 7:00 am 3:30 pm Fresno, CA 93727
More informationDesigning Safety Into Products
Designing Safety Into Products A continuous analysis of alternatives Mark Lafranconi Toxicologist April 11, 2012 Topics Fundamentals How is this applied at P&G? Examples P&G s Business Scope Approx 350
More informationSAFETY DATA SHEET CLEARAM CH MODIFIED STARCH
SECTION 1 : Identification 1.1 Product identifier: SAFETY DATA SHEET CLEARAM CH 20 20 - MODIFIED STARCH Product name: CLEARAM CH 20 20 - MODIFIED STARCH Chemical name: Acetylated distarch adipate CAS-No.:
More informationMINERAL HYDROCARBONS IN COSMETIC LIP CARE PRODUCTS. ***** Recommendation *****
COSMETICS EUROPE RECOMMENDATION N 14 17-09-2018 Former version: March 2013 Contact: Florian Schellauf E-mail: fschellauf@cosmeticseurope.eu MINERAL HYDROCARBONS IN COSMETIC LIP CARE PRODUCTS ***** Recommendation
More informationSAFETY DATA SHEET According to regulation (EU) No. 453/2010 DATE
SAFETY DATA SHEET According to regulation (EU) No. 453/2010 DATE 12-18-2017 1. PRODUCT AND COMPANY IDENTIFICATION Product Name: Brampton PRO-FIX Epoxy 5 & 10 Rapid Cure Product type: Epoxy Resin Restriction
More informationENV 455 Hazardous Waste Management
Risk Assessment Basic Information ENV 455 Hazardous Waste Management Environmental Risk Assessment Özgür ZEYDAN (Phd.) http://cevre.beun.edu.tr/zeydan/ Hazard: a potential source of harm to a worker. Risk:
More informationTECENTRIQ 1200 mg/20 ml
Safety Data Sheet TECENTRIQ 1200 mg/20 ml SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code TECENTRIQ 1200 mg/20 ml SAP-10154949
More informationSAFETY DATA SHEET. Section 1: Identification of the substance/mixture and of the company/undertaking. Section 2: Hazards identification
Page: 1 Compilation date: 01/08/2010 Revision date: 03/10/2013 Revision No: 7 Section 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name: Product
More informationProactive Integration of Occupational Toxicology Assessments into the Drug Development Process
Proactive Integration of Occupational Toxicology Assessments into the Drug Development Process Greg Erexson, PhD, DABT, ATS 14 July 2015 AbbVie, Inc. North Chicago, IL Disclosure Statement This presentation
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 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 informationFOOD CONTACT COATINGS --- A MANUFACTURER S PERSPECTIVE
FOOD CONTACT COATINGS --- A MANUFACTURER S PERSPECTIVE Presented to Mechanical Association Railcar Technical Services Conference September 17, 2009 By Madelyn K. Harding Senior Manager, Corporate Regulatory
More informationPart 2. Chemical and physical aspects
Part 2. Chemical and physical aspects 12. Chemical and physical aspects: introduction 12.1 Background information used The assessment of the toxicity of drinking-water contaminants has been made on the
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 informationSDS, Safety Data Sheet EverClean, LLC RAW Fiber Rinse SDS Date: January 20, 2017
SDS, Safety Data Sheet EverClean, LLC RAW Fiber Rinse SDS Date: January 20, 2017 Section 1: Identification Product Name: RAW Fiber Rinse (Concentrated) Revision Date: None Manufacturer/Distributor EverClean,
More informationSafety Data Sheet Suga Nate 160
SECTION 1 IDENTIFICATION GHS Product Identifier Trade Name: CAS Number: 742087-49-6 Uses of the Substance / Mixture: Surfactant for various applications Formula: N/A Synonym: Sodium Laurylglucosides Hydroxypropylsulfonate
More information- Chemical characterisation / Description: Mixture of the substances listed below with harmless additions:
Alfred Becht GmbH Carl-Zeiss-Str. 16, D-77656 Offenburg EC Material Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) *and Regulation (EU) Nr. 453/2010 amended by Regulation (EU) No.
More informationProvisional Translation Original: Japanese
Provisional Translation Original: Japanese Regarding Establishment of the level to be determined by the Minister of Health, Labour and Welfare, at the Pharmaceutical Affairs and Food Sanitation Council
More informationPRODUCT: Ethyl alcohol (denatured) CHEMICAL ABSTRACT NO.: Mixture. Ethyl alcohol ppm Flammable
MATERIAL SAFETY DATA SHEET ETHYL ALCOHOL (DENATURED) Section I - IDENTIFICATION PRODUCT: Ethyl alcohol (denatured) SYNONYMS: Denatured ethanol CHEMICAL FORMULA: C 2 H 5 OH CHEMICAL ABSTRACT NO.: Mixture
More informationModule 34: Legal aspects, ADI and GRAS status of food additives
Paper No.: 13 Paper Title: FOOD ADDITIVES Module 34: Legal aspects, ADI and GRAS status of food additives 34.1 Legal Aspects of Food Additives The data provided by Joint Expert Committee on Food Additives
More informationMaterial safety data sheet According to Regulation (EU) No 453/2010
SECTION 1 IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product code : BAR'S RHIZEX TABLETS : TAB 1.2. Relevant identified uses of the substance or mixture
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 6 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Pfizer Animal Health Pfizer Inc 235 East 42nd Street New York, NY 10017 Poison Control Center Phone: 1-866-531-8896
More informationUse of TTC and Human Relevance George E. N. Kass, PhD
Use of TTC and Human Relevance George E. N. Kass, PhD Future Challenges in Developing Assessment Methodologies for Human Health Effects Tokyo, 14 November 2018 Disclaimer The views, thoughts and opinions
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 informationGSC CODEX MESSAGE CCFA48/2016/25
FORM FOR THE SUBMISSION OF SUBSTANCES TO BE EVALUATED BY JECFA In completing this form, only brief information is required. The form may be retyped if more space is needed under any one heading provided
More informationMaximum Residue Limits
Maximum Residue Limits a scientific approach to ensure consumer safety ànd (food) animal health Prof Dr Erik De Ridder 1 Residues & safety: ADME Metabolism Distribution Excretion Administration Absorption
More informationAspartame Material Safety Data Sheet
Newseed Chemical Co., Limited Material Safety Data Sheet MSDS SECTION 1- PRODUCT AND MANUFACTURER IDENTIFICATION Product Name: Manufacturer: Manufacturer s Address: China manufacturer Telephone: Fax: SECTION
More informationCHEMICAL IDENTITY. INCI NAME: propylene glycol IUPAC: propane-1,2-diol CAS: EC NUMBER: EMPIRICAL FORMULA: C3H8O2 STRUCTURAL FORMULA:
PROPYLENE GLYCOL CHEMICAL IDENTITY INCI NAME: propylene glycol IUPAC: propane-1,2-diol CAS: 57-55-6 EC NUMBER: 200-338-0 EMPIRICAL FORMULA: C3H8O2 STRUCTURAL FORMULA: PHYSICAL FORM: Colourless Transparent
More informationMaterial safety data sheet
Page 1 / 6 Material safety data sheet according to Regulation (EC). N. 1907/2006 Parasitic diseases complete ELISA kits Reference Aspergillus fumigatus complete ELISA kit 6100 Toxocara canis complete ELISA
More informationSafety Data Sheet according to Regulation (EC) No 1907/2006
Safety Data Sheet according to Regulation (EC) No 1907/2006 NC-AA NO CLEAN WICK Page 1 of 9 sds no. : 249903 Revision: 16.10.2013 printing date: 27.01.2015 SECTION 1: Identification of the substance/mixture
More informationSafety Data Sheet according to Regulation (EC) No1907/2006
Safety Data Sheet according to Regulation (EC) No1907/2006 SPOT-ON SOLDER RESIST Page 1 of 10 SDS No. : 153925 Revision: 06.05.2014 printing date: 18.12.2014 SECTION 1: Identification of the substance/mixture
More information1. COMPANY AND PRODUCT IDENTIFICATION 2. HAZARDS IDENTIFICATION
Safety Data Sheet 1. COMPANY AND PRODUCT IDENTIFICATION ilovetocreate A Duncan Enterprises Company 5673 East Shields Avenue Fresno, CA 93727 559-291-4444 559-291-9444 (Fax) EMERGENCY TELEPHONE NUMBERS
More informationCOMMISSION REGULATION (EU)
11.3.2011 Official Journal of the European Union L 64/15 COMMISSION REGULATION (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council
More informationProf. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods
Guidance on Novel Foods Composition, production process and specification Prof. Marina Heinonen University of Helsinki Member of the NDA Panel and EFSA s WG on Novel Foods Info-Session 06 March 2017 Parma
More informationRisk Management Option Analysis Conclusion Document
Risk Management Option Analysis Conclusion Document Substance Name: tributyl O-acetylcitrate (ATBC) EC Number: 201-067-0 CAS Number: 77-90-7 Authority: France Date: August 2016 Version 2.1 October 2015
More informationSAFETY DATA SHEET. Section 1: Identification of the substance/mixture and of the company/undertaking. Section 2: Hazards identification
Page: 1 Compilation date: 31/03/2015 Revision No: 8 Section 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name: 1.2. Relevant identified uses
More informationMATERIAL SAFETY DATA SHEET. Product name : CL-427 Page: 1 de 5 Date : 08/12/2005. : Crosslinker CL-427
Product name : CL-427 Page: 1 de 5 1 IDENTIFICATION OF THE SUBSTANCE Commercial tradename: Application Manufacturer : Crosslinker CL-427 : Polifunctional aziridine Crosslinker. : MENADIONA, S.L. Pol. Ind.
More informationTTC NON-CANCER ORAL DATABASES
TTC NON-CANCER ORAL DATABASES Dr Sue Barlow Consultant in toxicology & risk assessment suebarlow@mistral.co.uk EUROTOX CEC on TTC 13 September 2015 Overview of presentation Rationale for TTC values for
More information1. Identification of the substance / mixture and of the company / undertaking
SAFETY DATA SHEET according to Regulation (EC) No 1907/2006 Version 5.0 Revision Date: 22.11.2016 Print Date: 08.05.2017 1. Identification of the substance / mixture and of the company / undertaking 1.1
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 information- Notification to specify uniform limit (Ministry of Health, Labour and Welfare Notification No. 497, 2005)
Syoku-An No.1129001 November 29, 2005 *1 Director Notice *2 Department of Food Safety Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Establishment of Applicable Laws and Ordinances
More informationMaterial Safety Data Sheet: BONAMAIN PLUS MRSA. Cleaning of hard floor surfaces
Page 1 of 5 BONASYSTEMS LTD Material Safety Data Sheet: BONAMAIN PLUS MRSA Date of issue: June 2013 Revision No: 1 Reason for issue: New product. 1 Product and Company Information Product Name: Intended
More informationCurrent status of Benchmark Dose Modeling for 3-Monochloropropane-1,2-diol (3-MCPD)
Current status of Benchmark Dose Modeling for 3-Monochloropropane-1,2-diol (3-MCPD) Michael Dourson, PhD, DABT, FATS, FSRA Professor, Risk Science Center (formerly TERA) Department of Environmental Health
More information: Pro 1 Oil Supplement
Date of issue: 03/18/2016 Version: 1.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Product name : Mixture Product code : 93400
More informationREVISION MATERIAL SAFETY DATA SHEET
REVISION MATERIAL SAFETY DATA SHEET 1 PRODUCT AND COMPANY IDENTIFICATION Product Name: PRESEPT* Disinfectant Tablets PRESEPT* Disinfectant Granules Chemical Composition: Contains Sodium dichloroisocyanurate
More informationDose and Response for Chemicals
Dose and Response for Chemicals 5 5 DOSE AND RESPONSE FOR CHEMICALS All substances are poisons; there is none which is not a poison. The right dose differentiates a poison and a remedy. Paracelsus, 16th
More informationOASIS PRO CITRUS GINGER ROOM REFRESHER. Use only for the purpose on the product label.
SAFETY DATA SHEET OASIS PRO CITRUS GINGER ROOM REFRESHER Section 1. Chemical product and company identification Product name Recommended use and restrictions OASIS PRO CITRUS GINGER ROOM REFRESHER Air
More informationSAFETY DATA SHEET Clean Hands
Clean Hands Page 1 of 9 SAFETY DATA SHEET Clean Hands The safety data sheet is in accordance with Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European
More informationSAFETY DATA SHEET BICOWHITE COMPLEX. SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product Identifier BW_S3
Pag. 1/9 SAFETY DATA SHEET SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product Identifier Code 1.2 Relevant identified uses of the substances or mixture and uses
More informationStep by Step Approach for GPS Risk Assessment
Step by Step Approach for GPS Risk Assessment 1) Tier Categorization and Prioritization 2) Hazard Characterization By Mr. Krittanon Yuen-ying (Product Regulatory) Dow Chemical Thailand Limited Email: krittanon.yuen-ying@dow.com
More informationDermal Occupational Exposure Limits. Their use in risk assessment
Dermal Occupational Exposure Limits Their use in risk assessment Contents 1. Risk assessment for dermal exposure 2. Dermal Occupational Exposure Limit (DOEL) 3. REACH 4. SCOEL 5. ECETOC 6. Summary Risk
More information1. Identification of the substance/mixture and of the company/undertaking Rheinfelden
1. Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier 1.2 Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses
More informationMATERIAL SAFETY DATA SHEET WILKINSONS GROUT CLEANER
MATERIAL SAFETY DATA SHEET WILKINSONS GROUT CLEANER 1. IDENTIFICATION OF THE PREPARATION AND THE COMPANY: SUBSTANCE NAME: Wilkinsons Grout Cleaner APPLICATIONS: Wilkinsons SUPPLIER: Business Park Abergele
More informationPoly-fluoroalkyl substances (PFASs), also called perfluoroalkyl substances (PFASs)
Poly-fluoroalkyl substances (PFASs), also called perfluoroalkyl substances (PFASs) Perfluorooctane sulphonic acid (PFOS), and perfluorooctanoic acid (PFOA) belong to a group of man-made compounds called
More informationSafety Data Sheet PT25R
Safety Data Sheet dated 14/7/2011, version 3 1. IDENTIFICATION OF THE PRODUCT AND OF THE COMPANY Trade name: Product type and use: Company: LEGOR GROUP S.p.A. Via del Lavoro, 1 36050 Bressanvido (VI) Italy
More informationSafety Data Sheet. : PC Cleaning Kit Screen Cleaner. : Yorkshire Way, West Moor Park Doncaster, South Yorkshire DN3 3FB UK
Section 1: Identification 1.1 Product Identifier Product Name Fellowes Item Number : PC Cleaning Kit Screen Cleaner : 99779 1.2 Relevant Identified Uses of the Substance or Mixture and Uses Advised Against
More information- draft scientific opinion -
The Re-evaluation of faspartame - draft scientific opinion - Dr. Alicja Mortensen Chair of EFSA s ANS Panel Follow-up meeting on the web-based public consultation on aspartame 9 April 2013, Bruxelles Draft
More informationSafety Datasheet (according to EC regulation 453/2010/EC) Exosex SPTab Date SDS290 Exosex SPTab
1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Exosex SPTab E290 1.2. Relevant identified uses of the substance or mixture and uses advised against For
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/451/98-FINAL June 1998 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS BACITRACIN SUMMARY REPORT (1)
More informationFENTOX 10% EC. AL-Burj Agrivet
FENTOX 10% EC Introduction: Fentox is a Insect growth regulator; suppressor of embryogenesis, inhibitor of metamorphosis and inhibitor of reproduction. It s used to Control of public health insect pests
More informationMENNEN SPEED STICK DEODORANT REGULAR
SECTION 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Product code : 200000020498 : B0650113M Manufacturer or supplier's details Company : Colgate-Palmolive Co 300 Park Avenue New York, NY 10022
More informationSafety Data Sheet 1907/2006/EC, 1272/2008/EC
Page 1/6 SECTION 1: Identification of the substance/mixture and of the company/undertaking Product identifier Registration number: Relevant identified uses of the substance or mixture and uses advised
More information1. Identification of the substance/mixture and of the company/undertaking
MATERIAL SAFETY DATA SHEET BICASEAL PUTTY ACTIVATOR ISSUE Number: 1 ISSUE DATE: 29 th April 2015 1. Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Bicaseal
More informationSAFETY DATA SHEET. Issue Date: 05/25/2015 Version No: 1 1. Identification
Page 1 of 7 1. Identification Product identifier Application of the substance or the preparation Addition curing vinyl polysiloxane dental impression materials (consisting of Base & Catalyst) Manufacturer/Supplier
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 informationSOFTSOAP LIQUID HAND SOAP ANTISEPTIC
SECTION 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Product code : 200000029129 : B02913790001 Manufacturer or supplier's details Company : Colgate-Palmolive Co 300 Park Avenue New York, NY 10022
More informationSafety Data Sheet. (Lauramide DEA) Lauramide DEA DATE PREPARED: 8/24/2015. Section 1. Product and Company Identification
Section 1. Product and Company Identification Lauramide DEA Product Name CAS Number 120-40-1 Parchem - fine & specialty chemicals 415 Huguenot Street New Rochelle, NY 10801 (914) 654-6800 (914) 654-6899
More informationAVASTIN Vials 100 mg/4 ml
Safety Data Sheet AVASTIN Vials 100 mg/4 ml according to Regulation (EU) nr. 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product
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 informationIndustrial and Institutional Cleaning
Industrial and Institutional Cleaning Food and Beverage Processing Acidic cleaning for Dairy Industry 1 Introduction 2 Test Method -upon request- 3 Test Formulation 4 Summary Introduction Cleaning In Place
More informationOngoing review of legislation on cadmium in food in the EU: Background and current state of play
Directorate-General for Health & Ongoing review of legislation on cadmium in food in the EU: Background and current state of play - International ICCO workshop, London, 3-4 May 2012 Michael Flüh bind the
More informationThiophanate-methyl -MATERIAL SAFETY DATA SHEET
Thiophanate-methyl -MATERIAL SAFETY DATA SHEET 1. Chemical Product Identification Product Name: Thiophanate-methyl Molecular Formula: C 12 H 14 N 4 O 4 S 2 Molecular Weight: 342.4 Structural Formula: Chemical
More informationMicro-Blaze Emergency Liquid Spill Control
1. Identification of the substance 1.1 Identification of the substance or preparation Name: Micro-Blaze Emergency Liquid Spill Control 1.2 Use of the substance/preparation Main use category : Industrial
More informationDental City - VPS Putty SAFETY DATA SHEET
Issue Date: 2/5/207. Identification Page of 9 Product identifier Trade name: Dental City - VPS Putty 49-8008 Fast Set / 49-8006 Regular Set Application of the substance or the preparation Addition curing
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 informationDose response relationships: biological and modeling aspects
Dose response relationships: biological and modeling aspects Jason Aungst, Ph.D. Office of Food Additive Safety Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration The findings
More informationSAFETY DATA SHEET Mixtures 67/548/EEC / 1999/45/EC Chemical Name Index No. CAS No. EC No. REACH Registration Conc. Classification M-factor
1. IDENTIFICATION OF THE PREPARATION AND THE COMPANY SUBSTANCE NAME: ALUMINIUM CLEANER PARTS NO: 3051089 REACH ALL INGREDIENTS IN THIS FORMULATION HAVE BEEN REGISTERED (WHERE REQUIRED) FOR APPLICABLE USES.
More informationScientific Opinion on the safety and efficacy of sodium carbonate (soda ash) for all species 1
SCIENTIFIC OPINION Scientific Opinion on the safety and efficacy of sodium carbonate (soda ash) for all species 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 European
More informationSafety Data Sheet Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH)
Safety Data Sheet according to Regulation (EC) No. 1907/2006 (REACH) This Safety Data Sheet is prepared voluntarily: it is not required according to Article 31 of Regulation (EC) No 1907/2006 Section 1:
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 information: Flash Professional All Purpose Cleaner Lemon
Date of issue: 24/02/2016 Revision date: : Version: 1.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Trade name : Mixture : Flash
More information10% DETERGENT 10% DETERGENT C071. Mon to Fri 8.30am to 5.00pm
10% DETERGENT Date of issue: 22/02/2019 Revision date: 05/06/2015 : Version: 10.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form
More informationEFSA Info Session on Applications. Technical meeting on food flavourings applications. Parma, 20 th January 2015
EFSA Info Session on Applications Technical meeting on food flavourings applications Parma, 20 th January 2015 1 TOPICS General procedural & administrative issues Risk assessment challenges of toxicological
More informationMaterial Safety data sheet
1. IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND THE COMPANY / UNDERTAKING Product Name: UTURN - PLANT GROWTH REGULATOR CAS No. 76738-62-0 SUPPLIER: SEVROC PTY.LTD ABN: 09947875 STREET ADDRESS: 51
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 informationSafety Data Sheet TENARIS
Safety Data Sheet dated 14/7/2011, version 3 1. IDENTIFICATION OF THE PRODUCT AND OF THE COMPANY Trade name: Product type and use: Company: LEGOR GROUP S.p.A. Via del Lavoro, 1 36050 Bressanvido (VI) Italy
More informationFellowes UK Yorkshire Way, West Moor Park Doncaster, South Yorkshire DN3 3FB UK Telephone: + 44 (0) Fax: + 44 (0)
SECTION 1: COMPANY AND PRODUCT IDENTIFICATION Fellowes UK Yorkshire Way, West Moor Park Doncaster, South Yorkshire DN3 3FB UK Telephone: + 44 (0) 1302 836800 Fax: + 44 (0) 1302 836899 Product Name: Description:
More informationCancer thresholds, Cohort of Concern and other excluded substance groups
Cancer thresholds, Cohort of Concern and other excluded substance groups Prof. Alan R Boobis Imperial College London London, UK a.boobis@imperial.ac.uk Agrochemicals Cosmetics Domestic products Food and
More informationAddendum to the 2016 FAO/WHO Manual on pesticide specifications: revised Tablet Specifications for DT, ST and WT
Addendum to the 2016 FAO/WHO Manual on pesticide specifications: revised Tablet Specifications for DT, ST and WT Introductory Note: The revised model specifications for tablets (ST, WT, DT) have been jointly
More informationSAFETY DATA SHEET. Version: 1.1
Page 1 of 9 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING Product Identifier Trade Name: Chemical Family: EUCRISA Not determined Relevant Identified Uses of the Substance or Mixture
More informationS2O Laundry Sheets Version Number: 1.0 Date 27 th November 2014 Supersedes: Not applicable SAFETY DATA SHEET. S2O Laundry sheets
SAFETY DATA SHEET S2O Laundry sheets This Safety Data Sheet contains information about the potential risks to those involved in handling, transporting and working with this product, as well as describing
More informationSafety Data Sheet according to HPR, Schedule 1
Page 1/6 1 Identification Article number: 2087210001 Recommended use: Graffiti remover Restrictions on use: All other uses than those indicated on the product label and technical data sheet Manufacturer:
More information