GreenScreen For Safer Chemicals Hazard Assessment Guidance

Transcription

ESCRE ENGRENGreenScreen for Safer ChemicalsHazard Assessment GuidanceVERSION 1. 3 MARCH 2016

Cover Photos (from left) Thinkstockphotos/LIVINUS; Thinkstockphotos/Kim Steele; Thinkstockphotos/filmlandscape; Thinkstockphotos/artisteer

ESCRE ENGRENGreenScreen for Safer ChemicalsHazard Assessment GuidanceVER SI O N 1 . 3 MA R C H 2 01 6Clean Production Action designs and delivers strategic solutions for green chemicals,sustainable materials and environmentally preferable products.Copyright (2014–2016) by Clean Production Action. All rights reserved.

ii Clean Production Action GreenScreen Guidance v1.3 (March 2016)ContentsAcknowledgementsivGreenScreen Advisory GroupsvPrefacevi1. Purpose12. Scope13. Normative References14. Terms and Definitions25. General Requirements86. Process Overview87. Disclosure and Assessment Rules and Best Practice108. The Hazard Endpoints119. Procedure for Assessing Hazards (Use of Hazard Lists, Analogs, and Models)1410. Procedure for Classifying Hazards1611. Procedure for Applying GreenScreen Benchmarks 1912. Assessing and Benchmarking with Environmental Transformation Products2213. Assessing and Benchmarking Inorganic Chemicals2514. Reporting Requirements2615. Making Informed Decisions2716. Records2717. Annex I – GreenScreen List Translator (List Translator)2818. Annex II – Assessing and Benchmarking Mixtures3719. Annex III – Assessing and Benchmarking Polymeric Materials3920. Annex IV –Benchmarking Criteria4121. Annex V – Benchmarking Criteria Worksheet4222. Annex VI – Sources for Identifying Feasible and RelevantTransformation Products4323. Annex VII – Identifying Feasible and Relevant Transformation Products4424. Annex VIII – Determining Chemicals to Assess66

GreenScreen Guidance v1.3 (March 2016) Clean Production Action iiiTables & FiguresTable 1.GreenScreen Disclosure and Assessment Best Practice10Table 2.Groupings of GreenScreen Hazard Endpoints11Table 3.Modified Endocrine Activity Classifications for Select Endpoints12Table 4.Example GreenScreen Hazard Summary Table18Table 5.Data Gap Analysis for Benchmark-120Table 6.Data Gap Analysis for Benchmark-221Table 7.Data Gap Analysis for Benchmark-322Table A-1.Quick Steps to Conduct GreenScreen List Translator Assessments29Table A-2.Categorization of Specified Lists31Table A-3.Trumping Rules for Lists32Table A-4.Description of Hazard Classifications for List Translator33Table A-5.List Translator Hazard Summary Table33Table A-6.List Translator versus GreenScreen Scores34Table A-7.List Translator Scoring Algorithm35Table A-8.Reporting and Assessing Constituents of Polymeric Materials39Table A-9.Benchmark Worksheet42Table A-10. Common Sources Used for Identifying Transformation Products43Table A-11. Worksheet for Identifying Feasible and Relevant Transformation Products44Figure 1.Performing GreenScreen AssessmentsFigure 2.Hazard Criteria for Carcinogenicity and Mutagenicity916Figure A-1. Example Reporting Format for Mixtures38Figure A-2. Example Reporting Format for Polymeric Materials40

iv Clean Production Action GreenScreen Guidance v1.3 (March 2016)AcknowledgementsClean Production Action is committed to maintaining clear and transparent guidance forproducing comprehensive GreenScreen assessments and accurate Benchmark scores.As a result of increasingly widespread implementation of GreenScreen for Safer Chemicals,clarifications and additional guidance revisions are conducted on a regular basis in orderto uphold its scientific rigor and alignment with other global programs. This is accomplishedby in-depth technical discussions with GreenScreen advisory groups, who provide valuablefeedback and recommendations for improving the method resources. We would like toextend distinguished acknowledgement to the scientists and industry professionals whohave donated significant time and expertise toward the development and continuedupkeep of GreenScreen for Safer Chemicals.Key ContributorsLauren Heine, Ph.D., Executive Director, Northwest Green Chemistry,formerly Director GreenScreen ProgramMark Rossi, Ph.D., Executive Director, Clean Production ActionAmy Hunsicker, Technical Consultant, Clean Production ActionShari Franjevic, Education and Training Leader, Clean Production ActionIn producing the final guidance resources we thank Michelle Wilhelm Turner, Ph.D., CleanProduction Action’s new GreenScreen Program Manager for her in-depth content review andto David Gerratt of DG Communications for his creativity in design. In the end we as keycontributors take responsibility for any flaws or errors contained herein.Copyright (2014–2016) by Clean Production Action, All rights reserved. No part of thispublication is to be reproduced or utilized in any form or by any means, without prior writtenpermission from Clean Production Action.GreenScreen, GreenScreen for Safer Chemicals, and the GreenScreen tree logo are trademarks or registered trademarks of Clean Production Action, Inc. The marks Authorized GreenScreen PractitionerTM and GreenScreen BenchmarkTM are certification or collective membershipmarks licensed by Clean Production Action, Inc. Any entities using these trademarks must belicensed by Clean Production Action, Inc. For more information about Clean Production Actionand GreenScreen for Safer Chemicals, visit http://www.greenscreenchemicals.org.

GreenScreen Guidance v1.3 (March 2016) Clean Production Action vGreenScreen Advisory GroupsLicensed GreenScreen ProfilersGreenScreen Steering CommitteeToxServices, Inc.Bingxuan Wang, Ph.D., D.A.B.T.,ToxicologistEmily Golden, M.F.S., ToxicologistJennifer Rutkiewicz, Ph.D., ToxicologistMargaret Whittaker, Ph.D., M.P.H., CBiol.,F.S.B., E.R.T., D.A.B.T., ManagingDirector & Chief ToxicologistMegan Boylan, M.S., ToxicologistMouna Zachary, Ph.D., ToxicologistSara Ciotti, Ph.D., ToxicologistZach Guerrette, Ph.D., D.A.B.T.,ToxicologistClean Production ActionMark Rossi, Ph.D., Executive DirectorMichelle Wilhelm Turner, Ph.D.GreenScreen Program ManagerAmy Hunsicker, Technical ConsultantEric Rosenblum, Ph.D., ConsultingToxicologistNSF InternationalAmber Dzikowicz, Business Unit ManagerDon Ward, Sr. Research ToxicologistNancy Linde, Managing ToxicologistPhilip Alexandrin, Senior CertificationProject ManagerSciVera, LLCPatricia Beattie, Ph.D., D.A.B.T.,Vice President, Scientific DevelopmentGradientAri S. Lewis, M.S, PrincipalKim Reid, B.A., Principal ScientistTim Verslycke, Ph.D., PrincipalTom Lewandowski, Ph.D., D.A.B.T., E.R.T.,ATS, PrincipalAppleArt Fong, Ph.D., Toxicology andGreen Chemistry Program ManagerDSMFredric Petit, Director Innovation& SustainabilityTruus Tiemersma, Manager RegulatoryAffairsEnvironmental Defense FundJennifer McPartland, Ph.D.,Senior ScientistHewlett-Packard CompanyCory Robertson, Environmental ChemistCurtis Wray, Materials ChemistHelen Holder, Distinguished Technologist,HP Labs, Emerging Compute LabPaul Mazurkiewicz, Senior ScientistHewlett Packard EnterpriseChosu Khin, Chemical EngineerInternational Chemical Secretariat(ChemSec)Anna Lennquist, Senior ToxicologistJerker Ligthart, Senior Chemicals AdvisorShaw Industries, Inc.Troy Virgo, Director Sustainability& Product StewardshipMcFadden and Associates, LLCRoger Mcfadden, President,Chief Science OfficerUniversity of California BerkeleyAkos Kokai, Ph.D. candidate, Dept.of Environmental Science, Policy,and ManagementMegan Schwarzman, M.D., M.P.H.,Research Scientist & Lecturer,School of Public HealthUniversity of Massachusetts LowellPam Eliason, B.S. Chemical Engineering,Senior Associate Director and IndustryResearch Program ManagerOther Key AdvisorsTom Lent, Director, Healthy BuildingNetworkMichel Dedeo, Ph.D., Staff Chemist,Healthy Building NetworkAlex Stone, Sc.D., Senior Chemist,Safer Chemical Alternatives, WA Dept.of Ecology, Hazardous Waste & ToxicsReduction-HQBrian J. Penttila, Ph.D., iWatchChemsConsultingAmelia Nestler, Ph.D., Project Manager,Northwest Green Chemistry

vi Clean Production Action GreenScreen Guidance v1.3 (March 2016)PrefaceClean Production Action developed GreenScreen for Safer Chemicals as a publiclyavailable and transparent chemical hazard assessment method to help move oursociety quickly and effectively toward the use of greener and safer chemicals. It isused by a wide range of professionals, governmental bodies, non-profits, businesses,formulators, and product developers—anybody interested in assessing the inherenthazards of chemicals and their potential effect on human health and the environment.The guidance provided in this publication clearly outlines every step for performingGreenScreen assessments, including how to assess and classify hazards, applyBenchmarksTM, and make informed decisions. In addition, extensive guidance hasbeen developed on using GreenScreen List Translator to identify priority chemicalsof high concern.GreenScreen for Safer Chemicals is a method for comparative chemical hazardassessment that builds on the U.S. Environmental Protection Agency’s Design forEnvironment (DfE) approach and other national and international precedents including but not limited to the Organisation for Economic Cooperation and Development(OECD), Canada Domestic Substances List Methodology, the International JointCommission, the European Union’s Registration, Evaluation, Authorisation andRestriction of Chemicals (REACH) and Classification, Labeling and Packaging (CLP)Regulations, the Stockholm Convention on Persistent Organic Pollutants and theGlobally Harmonized System of Classification and Labelling of Chemicals (GHS).It is freely and publicly accessible, transparent and peer-reviewed.Regulatory requirements and toxicology continue to evolve rapidly, and new hazardclassifications, test data and science continue to emerge. This Guidance will beregularly revised and updated, particularly as new versions of important foundationalpieces, such as the GHS, are released.

GreenScreen Guidance v1.3 (March 2016) Clean Production Action 1Hazard Assessment Guidance v1.31. PURPOSE1.1 This document outlines the procedural guidance for performing GreenScreen assessments, includinghow to assess and classify hazards, apply benchmarks, and make informed decisions.1.1.1 GreenScreen assessment of a given chemical includes a comprehensive review of all availableinformation including 1) measured data from toxicological studies in the scientific literature,2) estimated data from suitable analogs and models, and 3) hazard lists.1.1.2 The hazard lists required for GreenScreen assessments are called GreenScreen Specified Listsand are included in GreenScreen Hazard Criteria. They are also included in GreenScreen ListTranslator (List Translator), which maps GreenScreen Specified Lists to hazard classifications.GreenScreen List Translator assessment is not equivalent to GreenScreen assessment; however,it can help to identify chemicals with known hazard attributes. GreenScreen List Translator isavailable through automated software to facilitate ease of use. (See Annex I for detailedGreenScreen List Translator guidance).2. SCOPE2.1 This document includes requirements for Licensed GreenScreen Profilers and Authorized GreenScreenPractitioners. This document is also intended to serve as guidance for general users seeking to generatecomprehensive and high quality GreenScreen assessments.3. NORMATIVE REFERENCES3.1 Familiarity with the documents listed below are part of the competency requirements for LicensedGreenScreen Profilers and Authorized GreenScreen Practitioners:3.1.1 Globally Harmonized System of Classification and Labelling of Chemicals (GHS), United Nations,New York and Geneva (GHS Rev.4 (2011)),1 and3.1.2 Design for the Environment (DfE) Program Alternatives Assessment Criteria for Hazard Evaluation,Office of Pollution Prevention & Toxics, U.S. Environmental Protection Agency (Version 2.0,August 2011).23.2 Apply the latest editions of references with unspecified dates or version numbers.3.3 References that have specified dates or version numbers should be applied according to the editionspecified. However, users are encouraged to review the most recent editions and any guidancedocuments available to gain further hs/ghs welcome 014-01/documents/aa criteria v2.pdf

2 Clean Production Action GreenScreen Guidance v1.3 (March 2016)4. TERMS AND DEFINITIONSTERMDEFINITION100 ppmA threshold used for inventorying substances in a product or material.One hundred (100 ppm) is equivalent to 0.01% by weight.1000 ppmA threshold used for inventorying substances in a product or material.One thousand (1000 ppm) is equivalent to 0.1% by weight.Acute AquaticToxicity (AA)The intrinsic property of a substance to be injurious to an organism in ashort-term, aquatic exposure to that substance (GHS, Chapter 4.1: Hazardsto the Aquatic Environment. 2009, United Nations).Acute MammalianToxicity (AT)Refers to those adverse effects occurring following oral or dermal administrationof a single dose of a substance, or multiple doses given within 24 hours, or aninhalation exposure of 4 hours (GHS, Chapter 3.1: Acute Toxicity. 2009, UnitedNations).AnalogSee Suitable Analog.Assessment ReportTemplateA report template used to document all findings gathered during a GreenScreenassessment.AuthoritativeSecondary SourcesA compilation of research studies that have been reviewed and analyzed by agroup that is not the author of the original study(ies) but that is a group of recognized authorities such as health profession organizations, accredited institutionsand universities, and governmental entities.AuthoritativeToxicologyDatabasesDatabase information that is reviewed, approved, and regularly updated by a groupof recognized authorities such as health profession organizations, accreditedinstitutions and universities, and governmental entities.Authorized GreenScreen PractitionerAn individual who has completed advanced GreenScreen training, has demonstrated scientific expertise and capacity to perform high quality GreenScreenassessments, and is licensed by Clean Production Action to conduct GreenScreenassessments for his or her registered organization.Bioaccumulation (B)A process in which a chemical substance is absorbed in an organism by allroutes of exposure as occurs in the natural environment (e.g., dietary and ambientenvironment sources). Bioaccumulation is the net result of competing processesof chemical uptake into the organism at the respiratory surface and from thediet and chemical elimination from the organism including respiratory exchange,fecal egestion, metabolic biotransformation of the parent compound and growthdilution (Arnot, J.A. and F.A. Gobas, A review of bioconcentration factor (BCF)and bioaccumulation factor (BAF) assessments for organic chemicals in aquaticorganisms. Environmental Reviews, 2006. 14: p. 257-297).Carcinogenicity (C)Capable of increasing the incidence of malignant neoplasms, reducing theirlatency, or increasing their severity or multiplicity (IARC. Preamble to the IARCMonographs: A. General Principles And Procedures: 2. Objective and scope. 2006[cited 2011 June 20]; Available from: jective0706.php).CASRNChemical Abstracts Service Registry Number (also known as “CAS#”)CatalystBy definition, catalysts are substances that modify or increase the ratesof reactions but are typically not consumed. However, they may be inhibited,deactivated, or destroyed by secondary processes.

GreenScreen Guidance v1.3 (March 2016) Clean Production Action 3TERMDEFINITIONChemical Substance(“Substance”)A substance of fixed composition, characterized by its molecular structure(s),which typically has an associated CASRN (and may also have synonym CASRNs).Synonyms include “constituent”; “ingredient”; “chemical”; “compound”;“component”.Chronic AquaticToxicity (CA)The intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycleof the organism (GHS, Chapter 4.1: Hazards to the Aquatic Environment. 2009,United Nations).Data Gap (DG)A Data Gap indicates that measured data and authoritative and screening listshave been reviewed, and expert judgment and estimation such as modeling andanalog data have been applied, and there is still insufficient information to assigna hazard level to an endpoint. When generating a final GreenScreen Benchmarkscore, the presence and number of Data Gaps in different hazard categoriescan result in downgrading the Benchmark. This can result in a final GreenScreenBenchmark “U” or the addition of a subscript DG (e.g., GreenScreen Benchmark2DG or -3DG).DevelopmentalToxicity (D)Adverse effects in the developing organism that may result from exposure priorto conception (either parent), during prenatal development, or postnatally to thetime of sexual maturation. Adverse developmental effects may be detected at anypoint in the lifespan of the organism. The major manifestations of developmentaltoxicity include: (1) death of the developing organism, (2) structural abnormality,(3) altered growth, and (4) functional deficiency (USEPA, Guidelines forDevelopmental Toxicity Risk Assessment. Federal Register, 1991. 56(234):p. 63798-63826).DfEDesign for EnvironmentEndocrine Activity(E) (Endocrine ActiveSubstance)An endocrine active substance is a substance having the inherent ability tointeract or interfere with one or more components of the endocrine systemresulting in a biological effect, but need not necessarily cause adverse effects.Endocrine activity is considered as a collection of modes of action, potentiallyleading to adverse outcomes, rather than a (eco)toxicological hazard in b/3132.htm).Endocrine Disruption(Endocrine Disruptor)An endocrine disrupter is an exogenous substance or mixture that altersfunction(s) of the endocrine system and consequently causes adverse healtheffects in an intact organism, or its progeny, or (sub)populations ne/definitions/endodis en.htm).Eye Irritation (IrE)Eye irritation is the production of changes in the eye following the applicationof a test substance to the anterior surface of the eye, which are fully reversiblewithin 21 days of application ubli/ghs/ghs rev04/English/03e part3.pdf).Feasible Environmental TransformationProduct (TP)An environmental transformation product that is likely to form/occur under naturalor artificial conditions because the chemical structure of the parent chemicalallows for certain types of transformations (e.g., hydrolysis) and because thosetransformations are likely to occur based on the functional use of the chemicalacross its life cycle (e.g., discharged to water). When generating a final GreenScreenBenchmark score, the hazards of any feasible and relevant transformationproducts are considered and can change the final Benchmark score. If the finalBenchmark is altered due to a transformation product, the subscript “TP” isadded (i.e., GreenScreen Benchmark-1TP, -2TP or -3TP).

4 Clean Production Action GreenScreen Guidance v1.3 (March 2016)TERMDEFINITIONFunctional AdditivesChemicals or mixtures added to impart desired physical characteristics ofa polymeric material or mixture.GHSGlobally Harmonized System of Classification and Labelling of ChemicalsGreenScreenAssessmentA GreenScreen assessment is a comprehensive chemical hazard assessmentthat is conducted using this GreenScreen for Safer Chemicals Hazard AssessmentGuidance -documents)and results in one GreenScreen Benchmark score (Benchmark-1, -2, -3, -4, or -U).GreenScreenBenchmarkTM CriteriaA set of algorithms or decision logic used to assign a GreenScreen Benchmarkscore to a chemical based on the hazard profile of the chemical. The Benchmarkcriteria include a combination or combinations of GreenScreen Hazard Endpointsand hazard classifications.GreenScreen ListTranslator (LT)A streamlined chemical hazard assessment developed by Clean ProductionAction that produces GreenScreen List Translator scores.GreenScreen ListTranslator (LT)scoresList Translator scores are based upon screening chemicals against GreenScreenSpecified Lists using GreenScreen List Translator guidance.“LT-1” means “Likely GreenScreen Benchmark-1”. If GreenScreen assessmentwas performed on the chemical, it would likely result in a Benchmark-1 score.“LT-P1” means “Possible GreenScreen Benchmark-1”. Frequently this means thatthe chemical appears on a list that does not translate directly to a single Benchmark score and Benchmark-1 is included in the range of possible Benchmarkscores.“LT-UNK” (“unknown”) indicates that a chemical is present on a GreenScreenSpecified List, but that there is insufficient information to classify the hazard asLT-1 or LT-P1. The LT-UNK score or the absence of a chemical on hazard lists doesnot mean it is safe. It may mean the chemical has not been reviewed by the bodypublishing the list or that the chemical has not yet been well tested. For completedetails on List Translator see Annex I.GreenScreenSoftware Provider—PharosThe Pharos Chemical and Material Library is a fee-based database that providesonline access to chemical hazard information for over 30,000 CASRN identifiedsubstances and reports GreenScreen hazard classifications and GreenScreen ListTranslator scores for chemicals by applying GreenScreen List Translator methodology.Developed and maintained by the Healthy Building Network, the Pharos Chemicaland Material Library (CML) is available at http://www.pharosproject.net.GreenScreenSpecified ListsGreenScreen Specified Lists are chemical lists generated by state, national, orinternational governments, authoritative bodies, and expert organizations. Theselists are recommended for use in identifying and classifying chemical hazards using GreenScreen Hazard Criteria. GreenScreen List Translator relies on these liststo generate preliminary hazard scores.

GreenScreen Guidance v1.3 (March 2016) Clean Production Action 5TERMDEFINITIONGreenScreenSpecified Lists—Authoritative andScreening ListsAuthoritative Lists are generated by recognized experts, often as part of agovernment regulatory process to identify chemicals and known associatedhazards. These lists are considered to be of high reliability and should only bechanged when new data or special circumstances clearly indicate that a newlevel-of-concern is warranted. Intervention of a Licensed GreenScreen Profileror Clean Production Action’s consulting toxicologist would be required tovalidate such a change.Screening Lists result in a classification with a lower level of confidencebecause at least one of the following is true of the list. It was:a. developed using a less comprehensive review,b. compiled by an organization that is not considered to be authoritative,c. developed using predominantly or exclusively estimated data, ord. developed to identify chemicals for further review and/or testing.3Hazard EndpointA specific type of adverse health outcome or physical property that can causeharm. GreenScreen guidance specifies 18 Hazard Endpoints that must beevaluated. A few examples include: Carcinogenicity, Acute Aquatic Toxicity,Bioaccumulation, and Flammability.Hazard SummaryTableA table provided in the GreenScreen Assessment Report Template used todocument and present the hazard classifications for all 18 Hazard Endpoints.The template can be downloaded at: documents.HomogeneousMaterial (“Material”)A uniform solid, liquid, or gas composed of one or more substances that cannot be mechanically disjointed, in principle. It may be a chemical formulation orcompound; a substance of unknown or variable composition, complex reactionproduct, or biological material (UVCB); or a combination of the two. Coatings andfinishes such as plating, powder coats, enamels, etc., are considered uniquehomogeneous materials.ImpurityResiduals from prior manufacturing processes or contaminants from raw materials(i.e., residual output or by-product from a prior process is a contaminant inputto the next process).Intentionally AddedSubstanceA chemical in a product that is added at any concentration to provide an intendedfunction in a product.LicensedGreenScreenProfilerA company with expertise in toxicology and comparative chemical hazardassessment that is licensed by Clean Production Action to provide GreenScreenassessments on a fee-for-service basis to any individual or organization whoseeks to commission one.3MixtureA chemical and its impurities; a formulated mixture of single chemicals;a combination of formulated mixtures, polymeric materials and/or singlechemicals (e.g., liquid cleaning product, fragrances, lotions, and printing ink).MonomerA molecule, typically small and of low molecular weight, that can be bonded toother molecules to form a als/profilers

6 Clean Production Action GreenScreen Guidance v1.3 (March 2016)TERMDEFINITIONMutagenicity &Genotoxicity (M)The more general terms genotoxic and genotoxicity apply to agents or processeswhich alter the structure, information content, or segregation of DNA, includingthose which cause DNA damage by interfering with normal replication (from documents/aa criteria v2.pdf).Neurotoxicity (N)An adverse change in the structure or function of the central and/or peripheralnervous system following exposure to a chemical, or a physical or biological agent(USEPA, Guidelines for Neurotoxicity Risk Assessment. Federal Register, 1998.63(93): p. 26926-26954).OligomerA polymer or polymer intermediate containing up to five monomers.Persistence (P)The length of time the chemical can exist in the environment before beingdestroyed (i.e., transformed) by natural processes index.html).PolymerA compound comprised of chains of repeating units called monomers.Polymeric MaterialA special kind of formulated mixture made of repeating units called monomers(e.g., compounded plastics, adhesives, foams, resins).Processing AidsChemicals that are used to provide a technological effect in processing but notechnical or functional effect in the product and may remain in small amountsin finished product (e.g., lubricants, mold release agent).ProprietaryIngredientIngredients in products that are confidential to the manufacturer or producer.RelevantTransformationProductAn environmental transformation product that is: 1) persistent enough to beencountered after use or release of the parent chemical and 2) NOT a substancenecessary for life or commonly formed in the ambient environment.ReproductiveToxicity (R)The occurrence of biologically adverse effects on the reproductive systems offemales or males that may result from exposure to environmental agents. Thetoxicity may be expressed as alterations to the female or male reproductiveorgans, the related endocrine system, or pregnancy outcomes. The manifestationof such toxicity may include, but not be limited to, adverse effects on onset ofpuberty, gamete production and transport, reproductive cycle normality, sexualbehavior, fertility, gestation, parturition, lactation, developmental toxicity, premature reproductive senescence, or modifications in other functions that aredependent on the integrity of the reproductive systems (USEPA, Guidelinesfor Reproductive Toxicity Risk Assessment. Federal Register, 1996. 61(212):p. 56274-56322).RespiratorySensitization (SnR)Hypersensitivity of the airways following inhalation of the substance(GHS, Chapter 3.4: Respiratory or Skin Sensitization. 2009, United Nations).Skin Sensitization(SnS)A skin sensitizer is a substance that will lead to an allergic response followingskin contact ubli/ghs/ghs rev04/English/03e part3.pdf).Skin Irritation (IrS)The production of reversible damage to the skin following the application of a testsubstance for up to 4 hours (GHS, Chapter 3.2: Skin Corrosion/Irritation. 2009,United Nations).Special CaseImpurityChemicals of high concern typically found in a chemical or material andidentified based on life cycle knowledge, particularly of feedstock or upstreammanufacturing processes.

GreenScreen Guidance v1.3 (March 2016) Clean Production Action 7TERMDEFINITIONStrength of EvidenceA qualitative evaluation that considers the results of a clinical trial or researchstudy. The strength of the evidence will take into consideration how well a studywas designed, conducted, and analyzed, and evaluate the overall strength of thatbody of evidence.Suitable AnalogA chemical that can be used to estimate the hazard of the chemical of interestwhen data on the chemical of interest are not available. A suitable analog ischemically (e.g., based on chemical structure) and/or biologically (e.g., basedon metabolic breakdown, or likely mechanistic/mode of action considerations)similar to the chemical of interest. Guidance for identifying a suitable analog canbe found in OECD Series on Testing and Assessment No. 80 Guidance on Grouping of Chemicals. The suitable analog used must be appropriate for the attributebeing evaluated.4Systemic Toxicity& Organ Effects(includingImmunotoxicity) (ST)Includes all significant non-lethal effects in a single organ that can impair function,both reversible and irreversible, immediate and/or delayed, not otherwise coveredby any other endpoint; or generalized changes of a less severe nature involvingseveral organs.TransientTransformationProductsA transformation product that has a very short half-life and is typically anintermediate along a degradation pathway.Valid GreenScreenAssessmentGreenScreen assess

Table 4. Example GreenScreen Hazard Summary Table 18 Table 5. Data Gap Analysis for Benchmark-1 20 Table 6. Data Gap Analysis for Benchmark-2 21 Table 7. Data Gap Analysis for Benchmark-3 22 Table A-1. Quick Steps to Conduct GreenScreen List Translator Assessments 29 Table A-2. Categorizatio