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MeClas technical user manual

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1. EU zg REE d MecClas METALS CLASSIFICATION TOO MECLAS MEtals CLASsification tool for the classification of complex inorganic materials from the metals sector September 15th 2015 TECHNICAL USER MANUAL Contributors ARCHE Frederik Verdonck Vicky D hav Lieve Claeys Isabelle Vercaigne Patrick Van Sprang Marnix Vangheluwe EUROMETAUxX Violaine Verougstraete Hugo Waeterschoot European Copper Institute ECI Katrien Delbeke Katia Lacasse and Daniela Cholakova ICMM Benjamin Davies Euromines Johannes Drielsma EW roren A R C E EUROPEAN ASSOCIATION OF METALS v ASSESSING RISKS OF CHEMICALS Contents ke TAROT O Messi oct castrate tte esos E E cane aeetaaenacase wont G 3 lte SELISEORY saroien ected rattan detubeltitaaketa itd alten E datenblatt taal tt 3 Be ON ed atin desk ined a deta o S E la ines OA acd els ons oleate eda anes ai ae R 5 3 HOV S MECLAS sieves cag cic areata te gtd tog E doaamumea aisles 6 Jde Technical COTS iaee e EE Aera dba ateaibed E E ODOTA AAE 6 Stak Fred IDO aer E sa uesa anu daivsanencassateaiates 6 3 1 2 How is this tiered approach built in MeClas ccc ccccccsssseeeeccceeeeeaaaeeeeeeeeees 9 3 1 3 How does it work in the background 0 0 0 ceeeeessssseeeeecceeeeeeeeeeeeeeaaeeeeeeeseeeees 10 32 ne practice MeClas environmen sega csiseisiet ticecoh itis ist oharocaesg N 12 Soe User ManiialC lassie at Oni sas eesti cseset cr teceren E hice edema eet Maite
2. Show O C ex1 pH of TDP test pH 6 Element Conc Cu a Chalcocite Chalcopyrite Copper 1 oxide Copper lI oxide Covellite Digenite Enargite Tennantite The decision tree menu provides flow charts and reference to sources for more information Chemical Formula Cu5FeS4 Cu2S CuFeS2 Cu20 CuS CugSs Cu3AsS4 Cu12As4 13 E e 222 TDP 7 days test 100 00000 TDP 28 days test O C ex 1 Bio elution Relative species bio accessibility oral route at 200 mg L 100 00000 CuSO 100 00000 100 00000 100 00000 CuSO 100 00000 CuSO 100 00000 100 00000 Cuso 100 00000 100 00000 100 00000 CuSO 100 00000 CuSO 100 00000 100 00000 100 00000 100 00000 CuSO CuSO 100 00000 100 00000 CuSO 23 BP zy Bag a MecClas fads Ch ana ON Technical user manual 3 3 3 Manage alloy compositions The editing and managing of alloy compositions is very similar to ordinary compositions The reader is therefore referred to section 3 3 1 The main difference is e The speciation is limited to relevant speciation present in alloys e Tier 0 is not relevant for alloys The decision tree menu provides flow charts and reference to sources for more information 3 3 4 Calculate classifications and review intermediate calculations
3. or to the outside packaging of a hazardous product Label element means one type of information that has been harmonised for use in a label e g pictogram signal word LC50 50 lethal concentration means the concentration of a chemical in air or of a chemical in water which causes the death of 50 one half of a group of test animals LD50 means the amount of a chemical given all at once which causes the death of 50 one half of a group of test animals L E C50 means LC50 or EC50 MARPOL means the International Convention for the Prevention of Pollution from Ships Mist means liquid droplets of a substance or mixture suspended in a gas usually air Mixture means a mixture or solution of two or more substances which do not react Note Mixture and preparation are synonymous Mutagen means an agent giving rise to an increased occurrence of mutations in populations of cells and or organisms Mutation means a permanent change in the amount or structure of the genetic material in a cell NOEC means the no observed effect concentration OECD means the Organisation for Economic Cooperation and Development OSHA means the Occupational Safety and Health Administration Pictogram means a graphical composition that includes a symbol plus other graphic elements such as a border background pattern or colour that is intended to convey specific information Precautionary statement means a phrase and or pictogram
4. COMPOSITIONS the alloy via a separate menu a aa alas A decision tree was implemented to help with the choice of 1a ALLOYS l ADD EDIT ALLOY COMPOSITION CALCULATE CLASS DECISION TREE Tier selection When the maximum number 5 of free compositions is reached an upgrade is possible Funding members can enter an unlimited amount of compositions Please send an email to info meclas eu in order to find out how to upgrade the account To find out how many compositions are still left go to Tool Manage composition Add Edit composition For example Compositions 3 5 means there are still 2 compositions remaining 13 at zy Bag S MecClas fads Ch ana ON Technical user manual 3 3 User Manual Classification MECLAS enables Companies to create and manage their own company specific compositions Consortia or Technical Lead Companies to create and manage reference compositions Companies to edit and manage company adapted versions of the Consortia reference compositions Consortia companies to edit and manage ores concentrates compositions or alloys Consortia companies to calculate classifications and review intermediate calculations and assumptions The first and second points are covered by the same functionality described in the section below ot ee ae Pe ie 3 3 1 Manage compositions Select one of the following possibilities in the TOOL gt MANAGE COMPOSITIONS tab H TOOL B ABOUT MECLAS C
5. et cu 14 S35 Manage COMPOSITIONS epeei wealecatieedsdadees eto alee 14 JSL Add Cdit Own COMPOSIOM 2 iasesssstieiadcctranuisiseaneinaatvesieeosteeianwisiaeunceaesies 14 SL iad 0 8 8 OF fc 18 0 ds ee en eee ee nen tea mee nee eee Renee are eet 20 3 3 1 3 Import reference COMPOSITION COE sorrat ieni aE AE T ERE 20 JLA Adapt reference composition srssiooi ronnen n E EEE CEA 20 3 3 1 5 Adapt reference composition bulk upload s noosssesenennssssssseeeesssssssseeeeee 22 3 3 2 Manage ores concentrates O C COMPOSITIONS cccccccccceececeeeeeeeaseeeeeeeeeeees 23 3 3 3 Manage alloy COMPOSITIONS oreas r nna E E ete 24 3 3 4 Calculate classifications and review intermediate calculations ccceceeees 24 SD Review DaCk OTOUNG CalaDase mipri nenn nn E 24 A Lesalcontext and TUES erine E 25 Jo EXChanoc LOU ON aa E E E EE a OT E 26 O Disce ess aan E Pe mee SES E A ene 26 Te RONCO eea a E EEA E O A E R 21 Se O A E E AE E 28 Ww g BEE d MeClas eed ar eel Technical user manual 1 Introduction Chemical hazard identification and characterisation is not only an important step in risk assessment it is used in several regulatory schemes for example the transportation of dangerous goods identification of hazardous waste in occupational safety and health programmes etc In particular the Globally Harmonized System of Classification and Labeling of Chemicals GHS is an internationally agreed upon sy
6. for environmental classification Obviously Tier 3 is only useful if TDp data are filled out at zy BEE i d MeClas ar ee Technical user manual Note For Tiers 1 and 2 the distribution percentages ALWAYS have to be filled in even when there is only one form of a specific species For example Ag element is in the form of AgNO3 for 100 Element Conc Classification Entry Source Chemical Formula a relative to element Ag Ag massive gt 1 mm not classified Ag Ag other not classified not classified Ag compounds species Ag compounds e g self classification A AgCI Agl AgBr EPMF 9 Ag nano powder self classification A lt 100 nm EPMF 9 Ag powder lt 1 mm self classification A and gt 100 nm EPMF 9 There are several reasons to use the elemental composition as the primary key in defining a complex inorganic material e Elemental analysis are usually more readily available than speciation analysis e Elemental analysis is more accurate than speciation mineralogical analysis from the analytical point of view e Elemental analysis is often more complete more trace elements are measured which are often not detected in speciation mineralogical analysis 3 1 3 How does it work in the background In MECLAS the elements are linked to mineral or speciation forms which in turn are linked to classification entries 1 Link Elements to Mineralogy Species To link the elements to the appropriate species minerals th
7. percentage should be expressed per metal and per total complex metal mixture More guidance can be found in the MeClas Technical Manual Complex metal mixture selection xxtestexcel adapt ref sample demo version Optional create new input sheet for xxtestexcel or delete this version All elemental percentages have to be filled out without mentioning the unit For example when the element is present in a concentration of 5 it should be entered as 5 not as 0 05 or 5 The sum of the percentages of the elements should be equal to 100 The following elements can be seen on the screen pH of TDP test Surface area m2 g from reference material tested in TDP test Surface area m2 q of other than tested sample ref save changes clear all show all show selected entries Calculate gt 9 Concentration Concentration Distribution Species Classification TDP 7 Mt iere Element user input ref sample ref sample ent Source PELE 28 days bio accessibility E P E y y test at 200 mg L Ag Ag massive gt 1 mm not classified 100 00000 To save the changes click save changes A confirmation message appears on the screen Note that it is recommended to leave the elemental concentrations in the default scenario blank and to create a new version first Clear all can be used if all new input has to be cleared and the user wants to start from scratch If the input is already saved clicking this b
8. that classification rules may still differ between regions The CLP is the Regulation on the Classification Labelling and Packaging of substances and mixtures This Regulation aligns the previous EU legislation on Classification and Labelling of Substances Dangerous Substances Directive DSD 67 548 EEC and Preparations Dangerous Preparations Directive DPD 1999 45 EC to the UN GHS The CLP Regulation was published in the Official Journal on 31 December 2008 and entered into force on 20 January 2009 According to the Regulation the deadline for substance classification according to the new rules is December 12010 while for mixtures the deadline is June 1 2015 The CLP Regulation will ultimately replace the existing rules for Classification and Labelling of substances and preparations DSD and DPD after this transitional period The legal text of the CLP can be found on http eur lex europa eu LexUriServ LexUriServ do uri CELEX 32008R1272 EN NOT The guidance 2011 developed by ECHA for the application of the CLP criteria can be found on http echa europa eu web guest support guidance on reach and clp implementation This includes specific guidance for the environmental classification of metals and metal compounds OSHA Occupational Safety and Health Administration is part of the United States Department of Labor OSHA assures safe and healthful working conditions for men and women by setting and enforcing standards and providing train
9. ONTACT MANAGE compos ADD EDIT OWN COMPOSITION ORES AND CONCEIT MY COMPOSITIONS ALLOYS IMPORT REFERENCE COMP CODE CALCULATE CLASS ll ADAPT REFERENCE COMP SWITCH TO FORML ADAPT REFERENCE COMP BULK UPLOAD 3 3 1 1 Add edit own composition Anew composition can be created by clicking the link create a new composition or an existing composition can be chosen from the dropdown menu The first time that the company uses the tool a new composition has to be created Compositions 3 5 Please complete following fields Tier 0 elemental only e Tier 1 elemental and distribution e Tier 2 elemental and distribution TDP and or bio elution All percentages have to be filled out without mentioning the unit E g when the element is valid for the distribution TDP and bio elution percentages Ww Read more Show Make a choice Choose a composition from the list above or create a new composition To make a new composition when you are currently watching editing another composition one can also click new comp Please keep in mind that changes are not saved automatically when using this possibility pH of TDP test pH 6 ial tested in TDP test To edit a composition select a composition from the dropdown menu 14 re a MecClas fads Ch aera Technical user manual Compositions 3 5 Please complete following fields Tier 0 elemental only Tier 1 elemental and
10. TISM Tier 0 Classification based on worst case assumption for the elements This Tier is based on the concentration of the elements in the complex metal mixture as an input only Elemental analysis is usually determined using ICP inductively Coupled Plasma spectroscopy The classification is based on worst case speciation classification for every element For example Cr will be assumed to be in the speciation form of the CrO species because CrO has a worse existing classification than the Cr compounds Tier O can be used if speciation data are lacking therefore not relevant tier in case speciation mineralogical data are available The tool derives the classification based on Mixture toxicity rules e g summation method for environment Laig Ea L d MeClas GEN Oraii Technical user manual Tier 1 Classification based on speciation of elements Metal speciation metal mineralogy can be assessed from sequential extraction metal analysis and mineralogical analysis XRD and microscopes equipped with EDS Energy Dispersive Spectrometry and WDS Wavelength Dispersive Spectrometry analyzers The determination of the speciation requires in depth knowledge of metal particularities However the speciation results can easily be entered in MeClas Speciation results usually come in two formats see example figure below either as relative to the total mixture e g Lead metal 0 11 Litharge 0 09 and Galena 0 09 or relative to t
11. TOT MgO TOT MnO TOT NaZzO TOT Cad TOT Technical user manual relative to element Distribution of iran CuFeS 0 42 FeCr204 1 03 CoFeS 0 19 Cu 0 04 Fezsio4 37 89 Feco 4 91 KAJSIOx 2 09 Si F e ALCajo2 3 11 87 CaSiOx 32 78 ZnFeS 4 22 Fazo 4 54 Distribution of zinc FeCr204 2 56 ZnFeS 53 93 Fe2Sio4 17 88 KAJSIOx 2 26 CaSiOx 14 30 SifFe Al Cayo2 3 9 07 Distribution of copper Cures 49 61 FeCr204 0 09 Cu 42 17 FeCo 6 35 KAJSIOx 0 94 Si Fe AlCayo2 3 0 54 relative to total mixture CuFeS FeCr204 CoFeS Cu Fe2Sid4 FeCo CaSiOx ZnFeS Fe304 Calcopyrite 0 44 Chromite 0 63 Vilamninite 0 08 Copper 0 26 Fayalite 164 Fe alloy 0 67 K Al silicate 32 11 Glass 9 65 Ca siicate 37 51 Sphalerite 1 33 Magnette 0 54 By default 100 distribution in the worst case species is applied for each element If detailed information is available about the species mineral in which each element appears in the composition one can manually change the distribution percentages and remove the 100 next to the worst case form to avoid double calculations If this kind of information is not available maintain the default value as a worst case approach All numbers should be filled out without mentioning the unit For example when Ag is present in a concentration as 5 AgNOs3 it should be entered as 5 not as 0 05 or as 5 This is also valid for the elemental TDp and bio elution percenta
12. TRV i m Speciation Maintenance x EE TDP External Arche Upgrades Bio elution Labs MeClas Input code Company ocess code iaid Metal Metal Compound consortium consortium 6 Disclaimer The MECLAS tool aims to generate classifications for complex metal mixtures Although prepared with great care flawless operations cannot be guaranteed Users of the MECLAS tool need to be aware of this By using the MECLAS tool users accept full responsibility for their calculations Neither Arche Eurometaux nor the data providers can take liability for mis use of the results 26 Ww g BEE d MeClas METALS GLARSIFICATION TOOL Technical user manual 7 References ECHA 2009 Guidance on application of the CLP criteria ECHA European Chemicals Agency Helsinki Finland ECHA 2011 Guidance on application of the CLP criteria ECHA European Chemicals Agency Helsinki Finland EU 2008 Regulation EC No 1272 2008 of the European Parliament and of the Council of 16 December 2008 on classification labelling and packaging of substances and mixtures amending and repealing Directives 67 548 EEC and 1999 45 EC and amending Regulation EC No 1907 2006 OJCE L353 1 1355 2008 12 31 http eur lex europa eu LexUriServ LexUriServ do uri OJ L 2008 353 0001 1355 EN PDF the CLP Regulation IARC 2015 Agents classified by the IARC monographs volumes 1 113 Group 1 carcinogenic to humans http monogrpahs iarc
13. The classification can be calculated by e Selecting calculate classification from the Tool menu HOME TOOL ABOUT MECLAS CONTACT MANAGE COMPOSITIONS ORES AND CONCENTRATES O C ALLOYS l CALCULATE CLASSIFICATION e Selecting calculate when editing viewing a composition Calculate gt Sample X new comp Once the calculation classification sheet has loaded a metal mixture and the tier have to be selected A metal mixture should be chosen here When a composition is chosen an output method can be selected by clicking on the Tier Depending on the input Tiers 0 1 2 and 3 can be selected More information about the different tiers can be found in Section 3 1 For every endpoint the classification is given for CLP GHS and US OSHA The major driver for this classification is also mentioned visible when moving with the mouse over the classification In addition the pictograms for labeling are given for the different classified endpoints In addition transport information for MARPOL and IMSBC is given A summary report with the assumptions and the classification result CLP GHS and US OSHA can be downloaded in PDF or Excel by clicking on the icons above right 0 Intermediate calculations can be accessed by clicking the I button 3 3 5 Review background database The harmonized and self classifications of all metal and metal compounds can be found in the background database which can be accessed v
14. al Lead Companies to create reference classification compositions i e representative samples covering multiple companies 2 Companies to run company adapted versions of the Consortia reference classification compositions This is reflected in the tool manage compositions tab The use of own compositions in which companies or consortia can add and edit compositions share compositions via a unique code view subscribers to the compositions and delete compositions HOME TOOL ABOUT MECLAS CONTACT pP MANAGE composi ADD EDIT OWN COMPOSITION ORES AND CONCE MY COMPOSITIONS ALLOYS IMPORT REFERENCE COMP CODE CALCULATE CLASS i ADAPT REFERENCE COMP The second possibility is to import and adapt a ADAPT REFERENCE COMP BULK reference composition UPLOAD 12 re a MecClas METALS CLASSIFICATION TOOL MeClas users can also add and calculate the classification of ores and concentrates A separate menu was created for the ores and concentrates with TDP data on the mineral or ores and concentrate Technical user manual HOME TOOL ABOUT MECLAS CONTACT MANAGE COMPOSITIONS l ORES AND conce A ADD EDIT O C COMPOSITION WITH TDP ON O C ALLOYS ADAPT O C REFERENCE COMP WITH CALCULATE CLASS TDP ON O C ADD EDIT O C COMPOSITION WITH TDP ON MINERAL ADAPT O C REFERENCE COMP WITH TDP ON MINERAL DECISION TREE HOME TOOL H ABOUT MECLAS contact MecClas users with alloys can also calculate the classification of MANAGE
15. aterial that requires classification is different than the measured ones of the test sample a surface correction can be applied re a MecClas METALS CLASSIFICATION TOOL Technical user manual The surface correction approach can be applied if following criteria are met 1 Measured surface and or particles size distribution data are available for the test samples 2 Estimated measured surface particle size info available for the material that requires classification eg the massive form 3 Confirmation that normal handling and use of the massive form does NOT lead to a production of fine materials during normal handling and use production transport and use Useful when it is stated that drums should not contain gt 1 fines at the bottom Consequently based upon the defined estimated surface of the TDp results for the tested and the sample to be classified a surface correction factor will be applied and a check will be conducted if the material is still classified or less more stringent Tier 3 is only useful if the Tier 2 data TDP data are known and filled out Tier 4 Classification based on measured toxicity response testing This approach is based on actual eco toxicity testing and the results can be directly used for classification This is not included in the MeClas tool 3 1 2 How is this tiered approach built in MeClas On the MeClas website you will find the following table under Tool gt Manage
16. cancer or increase its incidence CAS means Chemical Abstract Service Competent authority means the authority or authorities or bodies established by the Member States to carry out the obligations arising from the GHS draft Regulation Contact sensitiser means a substance that will induce an allergic response following skin contact The definition for contact sensitiser is equivalent to skin sensitiser Corrosive to metal means a substance or a mixture which by chemical action will materially damage or even destroy metals Dermal corrosion see skin corrosion Dermal irritation see skin irritation Downstream user means any natural or legal person established within the Community other than the manufacturer or the importer who uses a substance either on its own or in a preparation in the course of his industrial or professional activities A distributor or a consumer is not a downstream user A re importer exempted pursuant to Article 2 7 c REACH Regulation shall be regarded as a downstream user Dust means solid particles of a substance or mixture suspended in a gas usually air EC50 means the effective concentration of substance that causes 50 of the maximum response EC Number or ECN is a reference number used by the European Communities to identify dangerous substances in particular those registered under EINECS EINECS means European Inventory of Existing Commercial Chemical Substances EU mean
17. cation and classification of ores and concentrates complex intermediates and has been proven to be relevant and efficient but also data hungry e g eco toxicity reference values have to be provided The original tool includes several tiers aiming for a progressive refinement of the classification through recognition of speciation specific mineral content and the availability of test data on the complex material in question However it does not include an extensive database on toxicity reference data sets neither it does include more complex features such as correction for Transformation Dissolution data for the environmental classification see Section 4 or bio elution for Human Health classification see Section 4 and or labelling guidance The original spreadsheet tool now has several limitations at zy REE d MeClas eed ar eel Technical user manual It has been circulated widely in different versions meaning that most of them are no longer up to date and no longer fulfil all refinement requirements Most complex materials such as ores and concentrates UVCB intermediates slags with a unique EINECS number and many other complex materials with unique EINECS numbers will require hazard assessment and appropriate classification These complex materials contain a spectrum of different metals compounds and minerals going beyond what is covered by the REACH consortia thereby requiring extensive physico chemical toxi
18. city and ecotoxicity reference data sets Consortia do not usually have automatic access to such data from other metals consortia As more self classifications and toxicity reference values become available over time as a result of test or data gathering obligations under REACH and CLP the tool requires continuous and rigorous updating A user can only use predefined compositions and cannot define its own composition for its materials In view of this complexity considering the above mentioned limitations of the original tool MeClas Metals Classification tool was developed to e Deal with the complexity of the hazard classification of complex inorganic UVCBs e Ensure consistent classification of complex inorganic UVCBs throughout the industry e Provide full recognition to metal specific aspects e Provide a platform for relevant data sharing between metal consortia self classifications and ecotoxicity reference values and between metal consortia and companies read across of speciation and bio availability tests Several versions were developed since then Version Date Main features Q3 2010 Spreadsheet tool translated into online tool Version 2 0 Q4 2012 CLP 2nd ATP updates on environment and sensitization bio accessibility correction for oral route module GHS mixture ruling module Version pone 0 Q4 2014 Ores and Concentrates module Marpol transport module Version 4 hoa Q3 2015 Alloys module GHS database of self class
19. compositions gt my compositions Click on one of your compositions or create a new one Show Demo composition Surface area m2 g from reference material tested in TDP test Surface area m2 g of other than tested sample Element Conc Classification Entry Ag Ag massive gt 1 mm Ag other not Classified compourda specias Ag compounds e g AQGL Agi Agiir Ag nano powder 4100 nm Ag powder lt 1 mm and gt 100 nm Ag2c03 Source not classified not classified self classification CPM soif classification EPMI sol classification EPMI self classification EPMF Calculate gt Demo composition mew comp DH of TDP test pHe6 35 TIER 3 Oral route 5 Bic elution Relative Chemical Formula versace dana teen Dio scosssibiiity one v at 200 mg L Ag 100 00000 Ag AQ Ag Ag Ag2CO3 TIER 0 1 2 E TIER 1 EE TIER 2 If only the concentration of the different elements of the complex material is available then the only classification option is to use Tier O which is the worst case calculation If besides concentrations the speciation column distribution is also filled out then a Tier 1 approach can be made When TDp and bio elution results are available a Tier 2 approach can be calculated When the surface area from the TDp tested reference material and that of the material to be classified other than tested sample are different and known the Tier 3 correction can be applied
20. dapt ref sample xxtestexcel adapt ref sample demo version xxtestexcel reference 2 22 Pr MecClas METALS CLASSIFICATION TOOL Technical user manual 3 3 2 Manage ores concentrates O C compositions The editing and managing of O C compositions Ores Concentrates is very similar to ordinary compositions The reader is therefore referred to section 3 3 1 The main differences are e The speciation is limited to relevant speciation and minerals present in ores and concentrates e Tier O is not relevant for ores and concentrates e The user can chose to specify TDP and Bio accesibility for each mineral separately or for each element TDP and or bio elution done on the O C as a whole as is the case in ordinary compositions This is reflected in the menu E TOOL J ABOUT MECLAS CONTACT MANAGE COMPOSITIONS P ORES AND CONCEI ADD EDIT O C COMPOSITION WITH TDP ON O C ALLOYS l ADAPT O C REFERENCE COMP WITH CALCULATE CLAS SWITCH TO FORML TDP ON O C IS and US and dedicated TDP ON MINERAL dule ADAPT O C REFERENCE COMP WITH TDP ON MINERAL DECISION TREE ADD EDIT O C COMPOSITION WITH This mainly impacts Tier 2 i e there is no difference in Tier 1 as shown in table below Add Edit O C composition with TDP on O C or Add Edit O C composition with TDP on mineral both give same result Add edit O C composition with TDP on O C Add Edit O C composition with TDP on mineral
21. data Transformation dissolution tests TDp are conducted to determine the rate and extent to which metals and sparingly soluble metal compounds can produce soluble available ionic and other metal bearing species in aqueous media under a set of standard laboratory conditions representative of those generally occurring in the environment Bio elution tests are conducted to estimate the bioaccessible fraction i e the fraction of the material soluble under physiological conditions by measuring the dissolution of the material in artificial biological fluids Classification is then corrected by considering the bio available elemental and or speciation concentration instead of the 100 soluble constituent concentration as in Tiers O and 1 Laig Bn E MeClas adn aerated Technical user manual relative to element concentration Zu TOT 0 60 Distribution of zinc Cu ugl 1 10 As TOT 0 00 FeGr204 2 56 As ugl lt DL Fe TOT 12 20 InFeS 63 93 Fe ugl 8 20 KAJSiOx 2 26 Co TOT 0 21 CaSiOx 14 30 Co ugl 0 02 BM Si Fe Al Ca O2 3 9 07 Sb TOT 0 01 Sb ugl lt DL Sn TOT 0 01 Sn ugl lt DL Zn TOT 0 46 Zn ugl lt DL Mo TOT Mo ugl lt DL AJ TOT 0 002 AJ ugl lt DL Se TOT Sr TOT Te TOT Distribution of copper Bi ToT CuFeS 49 61 ca TOT FeOr204 0 09 Cu 42 17 102 KEM 45 30 wt A203 TOT 13 20 Feco 6 35 Cr203 TOT 0 19 KAISIOn 0 94 K20 TOT 370 SiiFe Al Calo2 3 0 84 MgO TOT 6 80 nl ait 2 a Distributi
22. distribution Tier 2 elemental and distribution TDP and or bio elution All percentages have to be filled out without mentioning the unit E g when the valid for the distribution TDP and bio elution percentages Ww Read more Show Make a choice Choos Demo 2 ist above or create a new composition Demo 3 Demo composition On this page a name can be given or changed to a new existing composition black surrounded box Click in the black box and confirm new name by pressing enter or click save changes new comp pH of TDP test pH 6 The concentration of the different elements can be filled out Information about the distribution TDp and bio elution can also be entered ial tested in TDP test Fill out the following fields e Tier 0 elemental only e Tier 1 elemental and distribution e Tier 2 elemental and distribution and TDP 7 days test and or 28 days test and or bio elution e Tier 3 surface area of tested sample and of material to be classified m7 g Distribution percentage Distribution percentages relate to the speciation Tier 1 and should not exceed 100 for each element As demonstrated in the Figure below distribution percentages should not relate to the total composition of the metal mixture but should relate to the element metal 15 MeClas METALS CLASSIFICATION TOOL Se TOT Sr TOT 4 Te TOT B TOT Cd TOT S02 KEM AROS TOT XN Cr203 TOT K20
23. e results from worst case assumptions e g in Tier 0 selection of the species with the worst classification user expert judgment or species mineralogical analysis as in Tier 1 is used e g As 100 in the form of FeAs Cu 49 in the form of Cu2S and 51 in metal form Pb 98 65 in the form of PbO 1 05 in the form of PbS and 0 30 in the metal form In the case of several species the percent of distribution can be calculated e g Pb in the form of Pb metal 4 and PbO 1 gt percent contribution is respectively 80 Pb metal and 20 PbO In the case of multiple samples contributions the worst case can be taken If for some elements no mineralogical data are available the metal oxide sulfide or sulphate forms are assumed 2 Link mineral species to classification entry The minerals species are then linked to classification entries e g PbO links to the Pb compounds classification 10 at zg REE d MeClas METALS CLASSIFICATION TOOL Technical user manual SbSn0O links to the Sb compounds classification Some minerals are linked to several classification entries e g PbAsO links both to the Pb compounds and the As compounds classification Metal in inter metallic forms such as alloys can often be considered as metal form It is up to the user to decide if read across can be made to a similar compound FeZnO could link to the ZnO classification entry CoN
24. ecay of vision following application of a test substance to the anterior surface of the eye which is not fully reversible within 21 days of application 29 Ww g BEE d MeClas eed ar eel Technical user manual Signal word means a word that indicates the relative level of severity of hazards to alert the potential reader of the hazard the following two levels are distinguished a Danger means a signal word indicating the more severe hazard categories b Warning means a signal word indicating the less severe hazard categories Skin corrosion means the production of irreversible damage to the skin following the application of a test substance for up to 4 hours Skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours Skin sensitiser means a substance that will induce an allergic response following skin contact The definition for skin sensitiser is equivalent to contact sensitiser Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition Supplemental label element means any additional non harmonised type of information supplied on the container of a ha
25. ected for Tier 1 It is important to note that currently the oral route bio accessibility correction is done for following human health endpoints in scheme below Endpoints affected by Tier 2 human health bio elution corection Acute toxicity oral ORAL Acute toxicity inhalation route Acute toxicity dermal Skin corrosion irritation Serious eye damage eye irritation INHALATION Respiratory skin sensitization route Germ cell mutagenicity Carcinogenicity Reproductive toxicity DERMAL STOT Repeated Exposure The correct way of filling in the different fields of the composition is demonstrated with the following example Sample x contains 40 cadmium which is completely present in the form of sulphides According to a 7 days TDP test 50 of the cadmium in sample x is leaching out at 1 mg L sample loading The result of a gastric bio 18 i Ws MecClas GENON Technical user manual elution test 200 mg L sample loading showed that 20 of the cadmium in sample x is bio accessible Note that the bio elution percentage is linked to the cadmium sulphate form since one can assume that the measured cadmium in the gastric fluid will be present in the form of a soluble compound Show Sample X Calculate gt new comp pH of TDP test pH 6 Surface area m2 g from reference material tested In TOP test Surface area m2 g of other than tested sample Bio elution Oral route sistributi TDP Relative E
26. fr eng classification ICMM 2007 MERAG Fact sheet 8 Classification classification for effects on the aquatic environment of metals metal compounds and alloys http www arche consulting be Metal CSA toolbox MERAG ICMM 2009 HERAG Fact sheet Working draft Alloy specific approach to classification based on bioaccesssibility www icmm com document 659 ICMM 2009 Ores and concentrates An industry approach to EU Hazard Classification http www arche consulting be Metal CSA toolbox Ores and concentrates guidance on EU hazard classification UN 2007 Globally Harmonized System of Classification and Labelling of Chemicals Second revised ed New York and Geneva United Nations 2007 ST SG AC 10 30 Rev 2 ISBN 978 92 1 116957 7 http www unece org trans danger publi ghs ghs_revO2 02files_e html GHS Rev 2 27 Ww g BEE d MeClas eed ar eel Technical user manual 8 Glossary Alloy means a metallic material homogeneous on a macroscopic scale consisting of two or more elements so combined that they cannot be readily separated by mechanical means alloys are considered to be mixtures for the purposes of the GHS draft Regulation Aspiration means the entry of a liquid or solid chemical product into the trachea and lower respiratory system directly through the oral or nasal cavity or indirectly from vomiting Carcinogen means a chemical substance or a mixture of chemical substances which induce
27. ges The sum of the distribution percentages of each element must be equal to 100 This example can be filled out but is not possible sum is 400 Al massive Al compounds Al powder pyrophoric Al powder stabilised Al silicate Al 100 Al 100 Al 100 Al2SiO5 100 This on the other hand is correct sum is 100 ro Al massive Al i compounds Al powder pyrophoric Al powder stabilised Al silicate Al 1 Al 80 Al Al2SiO5 19 Note For Tiers 1 and 2 the distribution percentages must ALWAYS be filled in and the sum must equal 100 If you don t have information about the exact species you can use the default species as a worst case assumption 16 W Eni i METALS CLASSIFICATION TOOL Technical user manual Al deni not classified compounds Al powder pyrophoric Annex VI Al 100 00000 Al powder stabilised Annex VI Al Al silicate not classified Al2Si0O5 TDP percentage In the column with TDP percentages a default value of 100 related to complete solubility and noted in MeClas as 100 for every element is initially filled out for the 7 days test These predefined percentages can be replaced by actual TDP translation factors derived from TDP test results The TDP translation factors that should be entered correspond to the solubility at 1 10 or 100 mg L sample loading 7 days test results or 0 1 or 1 mg L sample loading 28 days test results for each tested metal The solubili
28. he metal element defined as distribution e g Pb metal 42 78 Litharge 31 85 Galena 25 37 Distribution percentages should not exceed 100 for each element The classification is then based on elemental and speciation data Cu TOT w D 60 a 2 ppe relative to element relative to total mixture e o 2 20 ay nine Distribution of iron mA EOLO O O e a ork om pari 5 tures Trara zas CuFeS 0 42 a gt Co TOT 0 21 Fecr204 103 FeCr204 Chromite 0 63 BM Cofes 9419 CaoFeS Vilarmninite 0 08 e PF af VOUres Varg Sb TOT ND lt 0 01 i Cu Copper 0 26 Sn TOT lt 0 01 ia mea Fe2Sid4d Fayalite 164 Zn TOT 0 86 FezSio4 37 89 z pp H A TAa Bl Mo TOT FeCo 4 91 FeCo Fe alloy Ag TOT lt 0 002 KASIO 209 KAISIOn K Al silicate 32 ny ar SifFe ALCajO2 3 Glass SiFe Al Cayo2 3 1 87 Se TOT paren ao 28 Sr TOT a Pe he Oe 22 16 Te TOT nFes 4 22 B TOT Faos 4 54 Cd TOT CaSiOx Ca siicate 37 6 Distribution of zinc ZnFeS Sphalerite 1 33 SiO2 KEM 46 30 Felr204 2 56 Fa304 Magnette 0 54 AROS TOT My 13 20 2nFeS 53 93 Cr203 TOT 19 oe 17 88 K20 ToT a 370 Fe2Si04 1 80 MgO TOT 6 80 KAISIOn 2 26 MnO TOT x 0 30 CaSiOx 14 30 Na2 TOT 10 Si Fe AlCajO2 3 9 07 Cad TOT 11 00 Distribution of copper Cures 49 67 FeCr204 0 09 Du 42 17 Feco 6 35 KAJSIOx 0 94 Si Fe Al CajoO2 3 0 84 Tier 2 Classification based on TDp or Bio elution correction benchmark Classifications can be corrected using TDp or Bio elution
29. iSbSO could link to both the NiSO4 and CoSO4 classification entry and also to the Sb compounds classification A link can also be made to different physical forms if available the metal massive form or the powder form particles lt 1 mm 3 Molecular weight conversion All elemental percentages have been transformed to the molecular weight of the relevant classification entry e g 1 For As compounds other than arsenic trioxide and arsenic pentoxide the molecular weight of As metal is used Arsenic compounds with the exception of those specified elsewhere in Annex VI 2 For PbO use of the molecular weight of Pb metal Pb compounds entry a PbO entry does not exist but ZnO conversion to molecular weight of ZnO ZnO entry 3 PbCuO conversion to the molecular weight of Pb metal Pb compounds classification and CuO copper Il oxide classification 4 Substance classification database Once the speciation mineralogical composition is calculated each species relative to total material the mixture rules can be applied using the classification of each species 11 at zg BEE MecClas fads Ch aera Technical user manual 3 2 In practice MeClas environment On the MeClas website www MeClas eu users can log in by entering their username and password In order to use the tool a registration and acceptance of the terms of conditions is required More general informati
30. ia the About MeClas background database menu HOME TOOL ABOUT MECLAS CONTACT P BACKGROUND DATABASE 24 y at MeClas A ar eel Technical user manual 4 Legal context and rules Following legal frameworks are implemented in MECLAS Legal framework Mixture ruling Background database of harmonized and self classifications GHS Implemented Not existing CLP Implemented Annex VI ATPs self classifications OSHA o Implemented GHS IARC monographs vol 1 112 for carcinogenicity Directive 1999 45 EC Implemented Annex VI 1 ATP self classifications Other regional implementations of GHS may be considered in MECLAS in the future The Globally Harmonised System GHS is an international standardised system for classifying chemicals and communicating their health and environmental hazards to consumers workers transport workers and emergency responders The system is undergoing worldwide implementation at national or regional level It also provides a basis for the harmonization of rules and regulations on chemicals at national regional and worldwide level Its main aims are to facilitate international trade in chemicals and to maintain the existing level of protection of human health and the environment The UN GHS incorporates a building block approach to facilitate implementation leaving it to the discretion of legislators to decide on the extent of implementation The drawback of this building block approach is
31. ifications module US OSHA mixture ruling database module EU older DSD DPD classification module removed Wt oy BEE a d MecClas GEN Oraii Technical user manual 2 Scope MECLAS is therefore facilitating the hazard ID for complex metal materials under CLP and DSD throughout the metal industry MECLAS is built on a limited number of simple and basic principles A tiered and inorganic specific approach allowing refinement in accordance with the following not necessarily sequential steps Tier 0 elemental concentrations only and worst case speciation and worst case 100 solubility Tier 1 speciation data and mineralogical evidence and worst case 100 solubility Tier 2 correction based on release solubility test data on the complex material and or bio elution Tier 3 Particle size surface area correction A up to date database including the official EU harmonised Annex VI of the CLP and subsequent ATPs and self classifications specific concentration limits the M factors ecotoxicity reference values ERVs values An open building block structure enabling the inclusion of specific side modules if relevant e g for Ores and Concentrates for Transport Classification additional reference lists e g Japan alloys etc The core engine contains the DSD DPD CLP and UN GHS hazard ID rulings and US OSHA forming the base of the MECLAS tool Confidentiality assurance for proprietary informati
32. ing TDp different classification entries for different physical forms for the environmental endpoint etc e data sharing specifics classification of complex inorganic materials requires having access to recent harmonised and reliable self classification and high quality ecotoxicity reference values of different inorganic metals compounds and minerals going beyond what is e g usually covered by existing legislation e g REACH registrations e Classification mixture ruling remains a difficult exercise even with the support of guidance ECHA 2013 UN 2008 requiring expert judgment and regular updates To address these difficulties MeClas was developed It is a web based tool to comply with the GHS EU CLP and US OSHA requirements for the hazard identification and classification of complex inorganic mixtures and materials based on the hazards of its constituents The tool includes links to ecotoxicity reference data bases and a series of assessment features that are crucial for metals and complex metal mixtures depending the status of the material and that to date the usual commercial tools do not include 1 1 History In 2009 ARCHE developed an initial classification soreadsheet tool for complex materials aimed at providing an automated expert judgement system for the hazard identification and classification of complex inorganic materials The tool was subsequently amended to be suitable for assessing appropriate hazard identifi
33. ing outreach education and assistance The OSHA clasification is based on GHS with exception of the carcinogenicity endpoint This endpoint is covered by the IARC Monographs a list of chemicals complex mixtures and agents that can increase the risk of human cancer The agents classified by the IARC Monographs volumes 1 112 are implemented in the MeClas database Discussions on the removal from the water column are still ongoing In the meantime reference is made to ECHA CLP Guidance 2009 on removal from the water column 25 at zy Bag d MecClas fads Ch ana ON Technical user manual 5 Exchange forum External labs have carried out experiments on different complex mixtures Reference compositions provided by the metal consortia and metal compound consortia The results of these speciation TDP and bio elution tests are integrated in MeClas Furthermore Eurometaux and Arche included the legal classifications as present in Annex VI of the CLP TRV values from data owners e g consortia or companies classification rulings from the CLP guidance and the agreed specific guidance on metals e g from MERAG HERAG etc Individual companies can use MeClas to create their own company specific classification compositions Moreover for metal and metal compounds Consortia can create reference classification compositions which can be used and adapted by companies if the access code is communicated Exchange forum QC
34. lement Conc Classification Entry Source Chemical Formula amy TOPS 7 a8 bio accessibility SAVE CHANGES relative to days test days test el at 200 mg L Cd 40 00000 Cd pyrophoric Annex VI Ca 50 00000 Cadmium compounds with the exception of cadmium sulphoselenide xCdS yCdSe mixture of cadmium sulphide with zinc sulphide xCdS yZnS mixture of cadmium sulphide with mercury sulphide xCdS yrtgS and those specified elsewhere in Annex Vi Annex Vi Ca Cd non pyrophoric Annex Vi Cad Ca other not Classified not classified Ca compounds species Cd compounds excluded from Classification cadmium sulphoselenide not classified mixture of cadmium Annex V1 sulphide with zinc sulphide mixture of cadmium sulphide with mercury sulphide Caci2 Annex Vi CaCi2 Cdo Annex Vi CaO CdS Annex VI CdS 100 00000 CdS ZnS not classified CdS2Zn CdSO4 Annex VI CaSO4 20 00000 Save changes When the composition is filled in click the save changes button or press enter The composition is then saved green marked lines If an element or self classification entry is missing please send an email to info meclas eu The new entry will be evaluated quality control by Eurometaux s selected quality control group for inclusion in MeClas 19 it zy BEE d MeClas A ar eel Technical user manual 3 3 1 2 My compositions To delete compositions go to the My compositions page To
35. n case of further refining the hazard From reference composition to all identification of an UVCB by consortium or company compositions for which company for one or more carefully selected source and process conditions is respresentative materials the same The objective of the input sheet is to adapt the elemental composition of a reference composition For this input specific elemental concentrations will overwrite default elemental concentrations from the reference composition The adapted company specific classification is then calculated If input boxes are left blank the value of the reference composition for that element is considered However if you do not wish to assume default concentrations overwrite the value from the reference sample by inserting zero 0 Note that the changes are user specific and will not overwrite the default values from the reference samples Other users that share the same reference sample will not view your adaptations Firstly select a metal mixture in the dropdown menu Adapt reference comp The objective of the input sheet is to adapt the elemental composition of a reference sample For this input specific elemental concentrations will overwrite elemental concentrations from reference sample where needed You need have imported a reference sample code first Enter a concentration in For example 5 should be entered as 5 and not as 5 or 0 05 Note that for speciation analysis the
36. ntly the speciation mineralogical pattern determined for a sample that is representative of a particular process or source and conditions is the same for all materials produced or mined according to the same process source or conditions Since the mineralogical composition is expressed as a relative percentage 20 ig y Bas d MecClas eed ar eel Technical user manual for each element a higher concentration for a particular element will automatically lead to a higher concentration of the corresponding mineral species Even so the bioavailability solubility pattern determined for a sample that is representative of a particular process source amp conditions is the same for all materials produced according to the same process The release is expressed as a relative percentage for each element Consequently a higher concentration for a particular element will automatically lead to a higher concentration of the releasing mineral species The table hereunder summarizes the two paragraphs above Testing Read cross within one UVCB Elemental analysis For each UVCB by each company and for multiple batches streams Speciation mineralogical In case of refining the hazard identification of an From reference composition to all analysis UVCB by consortium or company for one or company compositions for which more carefully selected respresentative materials source and process conditions is the same TDP or bio elution analysis I
37. ol gt Manage compositions gt My compositions and delete the required compositions To change the name of your composition go to the compositions page Tool gt Manage compositions gt Add edit compositions and click on the composition you want to change Once the compositions sheet is displayed click in the black box and type your new name Confirm by pressing enter or save changes To share compositions go to the My compositions page Tool gt Manage compositions gt My compositions On this page you can retrieve your compositions unique code select and copy the code view subscribers to your compositions and delete compositions When compositions are deleted the users who are subscribed to this composition will lose their data In this list it is also indicated whether or not the consortium is the author of acertain composition indicated with The user receiving the sharing code cannot edit the composition The use can only run elemental adaptations of the reference compositions This is further discussed in section 3 3 1 4 3 3 1 3 Import reference composition code Go to the Adapt reference comp page in the TOOL tab either under the Manage compositions or the Ores and concentrates menu If the company has received a composition code from a consortium or another company it can be entered in the field to gain access to the input and output data of this composition The company is asked
38. on Confidentiality of proprietary data is assured by having the ERVs for such substances hidden e GHS PEW CEH e US OSHA I a io sik d _ MeClas gt METALS CLASSIFICATION TOOL nd e MARPOL e IMSBC Transport J Ey MecClas fads Ch ana ON Technical user manual 3 How to use MECLAS 3 1 Technical context 3 1 1 Tiered approach Complex UVCB materials contain varying amounts of metals and metal minerals This section outlines how these complex materials can be identified and analysed in order to classify and to fulfil REACH and or CLP requirements in terms of toxicological and eco toxicological classification For complex metal mixtures the effects are not expected to be adequately described solely by their metal content i e the elemental composition is not sufficient on its own to derive classification A tiered approach needs to be used for analysis and interpretation The following tiers are built into the MECLAS tool SCHEMATIC OVERVIEW of the TIERED CLASSIFICATION APPROACH FOR COMPLEX MATERIALS TIER 0 Concentration of the components Classification of Lack of speciation on components TIER 1 Classification based on Speciation of the components Lack of rhs verification components TIER 2 Classification basedon gt elution correction benchmark Lack of animal validation Verified read across J90JIMONJ NISVIJY NI INCREASING CONSERVA
39. on about MeClas can be found in the toolbar version number FAQ what s new page In the ABOUT MECLAS tab the background database is displayed Questions can be asked and further information can be requested by filling out the form in the CONTACT tab MECLAS THE SMARTEST WAY TO FULFILL YOUR CLASSIFICATION OBLIGATIONS version 3 2 what s new FAQ help BWHOME ABOUT MECLAS CONTACT Wn oy P LICENSE NEWS LOGIN l f You must register in order to access New alloys module under beta Usemame d l the MeClas tool and all supporting l testing had been added in l f information A short description of i MECLAS l MeClas i the Tems of conditions can be f Password METALS CLASSIFICATION TOOL downloaded The mammi gives an idea on the basic functionalities of MeClas login register forgot password When logged in the company can view its profile by clicking view profile The name of the user and the organisation the position e mail and phone number of the registrant can be filled in or edited The password can also be changed If the user has forgotten his password he can leave his e mail address and will receive an e mail with further information on how to obtain a new password After logging in an extra tab will pop up TOOL HOME TOOL ABOUTMECLAS CONTACT MeClas enables 1 Companies to create their own company specific classification compositions and Consortia or Technic
40. on of ran Cad TOT 17 00 CuFeS 0 42 FaeCr204 1 03 CoFeS 0 19 Cu 0 04 Fe2504 37 89 FeCo 4 91 KAISIOn 2 09 Si Fe Al Ca 02 3 11 87 CaSiOx 32 78 ZnFeS 4 22 Fatina 454 Tier 3 Classification with surface area particle size correction Surface area is a crucial parameter in environmental classification of powders any variation in surface area tested may cause a significant change in the levels of metals ions released in a given time window Thus particle size or surface area is fixed for the purposes of the transformation test allowing the comparative classifications to be based solely on the loading level There may be cases where data generated for a particular metal powder are not considered as suitable for classification of the massive forms The powder may be classified separately based on the data generated on the powder However in normal circumstances it is not anticipated that more than two classification proposals would be made for the same metal The particle sizes tested and or used for classification and labelling depend on the substance being assessed and are shown in the table below Metal compounds Smallest representative size Never larger than 1 mm sold Metals powders Smallest representative size May need to consider different sources if yielding sold different crystallographic morphologic properties Default value may be altered if sufficient justification When the surface particle size info of the m
41. s Concentration in Maximum expected T D result mean original tested ug L Theoretical Solubility ug L 100 mg L sample content at 100 mg L Translation factor 20000 50 40 40000 If the release of one of the tested metals is below the detection limit zero should be filled out as TDP percentage For metals where no TDP results are available the default value of 100 should be maintained to avoid an underestimation of the classification result Note that the TDP translation factor for metal powder can be entered in the same field as for metal massive Bio accesibility percentage General note The methodology and regulatory acceptance for bio elution correction is still ongoing and will be updated as soon as more information becomes available For the moment only the oral route bio 17 Ey MecClas GEN Oraii Technical user manual accessibility correction is implemented For more information the reader is referred to the Eurometaux roadmap on bio elution The bio elution percentages that should be filled out in MECLAS correspond to the solubility at 200 mg L sample loading for each tested metal An excel calculator sheet can be found on the MeClas website Tool lt Manage composition lt Add Edit own compositions after expanding the Read more section Below you can find a screen shot of the calculator sheet mentioned above For each tested metal fill out the mean bio elution resul
42. s the European Union Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye which are fully reversible within 21 days of application GESAMP means the Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection of IMO FAO UNESCO WMO WHO IAEA UN UNEP GHS means the Globally Harmonised System of Classification and Labelling of Chemicals Hazard categories means the division of criteria within each hazard class Hazard class means the nature of the physical health or environmental hazard Hazard statement means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture including where appropriate the degree of hazard IARC means the International Agency for Research on Cancer IMO means the International Maritime Organisation Intermediate means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance hereinafter referred to as synthesis Label means an appropriate group of written printed or graphic information elements concerning a hazardous 28 at zy REE d MeClas eed ar eel Technical user manual product selected as relevant to the target sector s that is affixed to printed on or attached to the immediate container of a hazardous product
43. stem created by the United Nations that addresses classification of chemicals by types of hazard and proposes harmonized hazard communication elements including labels and safety data sheets UN 2011 Its main objectives are to facilitate international trade in chemicals and to maintain the existing level of protection of human health and environment CLP is the EU implementation of GHS EC 2008 One needs also to classify and provide labelling information for different inorganic complex materials like ores and concentrates UVCB Unknown of Variable Composition or of Biological Origin intermediates slags and mixtures like alloys under GHS EU CLP REACH and US OSHA These complex inorganic mixtures or materials have several specificities at stake e highly variable elemental composition selecting representative samples is difficult and unnecessary animal testings are to be avoided in view of toxicological and eco toxicological classification endpoints Therefore hazard estimation based on the hazards of the constituents is recommended e legal specific Different legal status under CLP REACH versus GHS requires different classification ruling complex mixtures versus complex substances e inorganic specific e g speciation mineralogy solubility bioavailability the effect of a matrix or physical form on solubility Metal classification guidance in GHS and CLP includes specific ruling for inorganics like the transformation dissolution test
44. t ug L and the metal concentration that was initially present in the sample fields that should be completed are highlighted in orange The bio elution translation factor that should be entered in MeClas appears then in the yellow field bio elution Concentration in Maximum expected ug L result mean original tested Theoretical content at Element ug L sample 200000 ug L Solubility Translation factor Pure metal Pb 1272 100 200000 0 636 juvecB PD 1is 084 1680 _0 1071429 lug metal released from Material S 18 Relative bio accessibility 0 1684636 ug metal released from UVCB ug metal present per ug UVCB tested ug metal released from pure metal ug pure metal tested In case of oral route bio elution tests such as gastric fluid intestinal saliva BARGE one can assume that the measured metals in the gastric fluid will be present in the form of soluble metal compounds Bio elution percentages should then be filled out in the row of the soluble compound in general the sulphate form is used for gastric test The value of zero should be entered for the other compounds of that metal If the bio elution for one of the tested metals is below the detection limit zero should be filled out as bio elution percentage For metals where no bio elution results are available a default value of 100 should be entered in the row that corresponds with the speciation form sel
45. that describes recommended measure s to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use QSAR means quantitative structure activity relationships REACH database means the classification amp labelling inventory established under Article 113 of the proposed REACH Regulation REACH Regulation means the Regulation EC No concerning the Registration Evaluation Authorisation and Restriction of Chemicals Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria means the latest revised edition of the United Nations publication bearing this title and any published amendment thereto Recommendations on the Transport of Dangerous Goods Model Regulations means the latest revised edition of the United Nations publication bearing this title and any published amendment thereto Respiratory sensitiser means a substance that induces hypersensitivity of the airways following inhalation of the substance RID means The Regulations concerning the International Carriage of Dangerous Goods by Rail Annex 1 to Appendix B Uniform Rules concerning the Contract for International Carriage of Goods by Rail CIM of COTIF Convention concerning international carriage by rail as amended SAR means Structure Activity Relationship SDS means Safety Data Sheet Serious eye damage means the production of tissue damage in the eye or serious physical d
46. ty can be calculated from the mean metal release and the maximum metal release expected from the sample composition taken into account the sample loading rate On the MeClas website Tool lt Manage composition lt Add Edit compositions a simple excel calculator sheet is provided that can be used to calculate the value that should be entered in the TDP column Expand the Read more section to download the TDP calculator Below you can find a screen shot of the calculator sheet mentioned above Dependent on the sample loading rate 1 10 100 mg L that was assessed the top middle or bottom panel should be used to calculate the TDP translation factor For each tested metal fill out the mean TDP result ug L and the metal concentration that was initially present in the sample fields that should be completed are highlighted in orange The TDP translation factor that should be entered in MeClas appears then in the yellow field Loading rate 1 mg L 7 or 28 days Concentration in Maximum expected T D result mean original tested ug L Theoretical Solubility Element ug L _ sample content at 1 mg L Translation factor OOO ltt 200 0j 40 Loading rate 10 mg L 7 or 28 days Concentration in Maximum expected T D result mean original tested ug L Theoretical Solubility ug L 10 mg L sample content at 10 mg L Translation factor PC 2000 40 000 50 Loading rate 100 mg L 7 or 28 day
47. utton does not undo this It only clears the input to be able to adapt the reference composition for another time 21 or MecClas METALS CLASSIFICATION TOOL Technical user manual Clicking Show selected entries selects the lines where the distribution is filled in from reference composition or adapted input so as to give an overview of all selected entries Show all shows all possible elemental and classification entries 3 3 1 5 Adapt reference composition bulk upload Complex metal mixture selection You can save multiple instances unlimited of one Reference Sample by selecting create new input sheet for your _ COMPOSITION4 default 1 composition It is recommended to leave the default sheet Optional create new input sheet for COMPOSITIONS blank and create new versions Give a name to the new instance and click on save and continue The new sheet has been added to the list the name of the new instance is put between brackets next to the name of the reference composition Unlimited instances of one Reference Composition can be saved To further adapt the reference compositions select the composition from the dropdown menu Complex metal mixture selection The new sheet has been added to the list Select a metal mixture Select a metal mixture Demo 2 default adapt ref sample Demo 3 default adapt ref sample Demo composition default adapt ref sample Sample X default a
48. whether it wants to add this composition to the input and output list Click yes To view or adapt the composition go to adapt reference comp Import reference sample code If you have received a composition code you can enter it in the field below to gain access to the input and output data of this composition Code case sensitive 38ABCOMFGAB08110934 submit code 3 3 1 4 Adapt reference composition run elemental adapted versions of the reference compositions For some complex metal materials due to the intrinsic similarities of the composition depending on the process or source a complete mineralogical analysis for all batch samples from all companies is not required Samples can therefore be selected and fully analyzed for representative UVCB processes and original materials Representative Compositions Reference Compositions Samples In view to characterize a reference composition the following points need to be considered e For each complex mixture the range in elemental compositions within and across all companies should be assessed and compared e For each complex mixture detailed information on the different process conditions if any should be evaluated in view of potential differences in resulting mineralogy i e speciation For each specific process type a representative sample can be selected and the metal species and or mineralogical forms can be determined by means of XRD analysis Conseque
49. zardous product that is not required or specified under the GHS In some cases this information may be required by other competent authorities or it may be additional information provided at the discretion of the manufacturer distributor Symbol means a graphical element intended to succinctly convey information UNCETDG GHS means the United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals UN means the United Nations UNEP means the United Nations Environment Programme WHO means the World Health Organisation 30

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