MERAG Fact sheet : Classification for effect on the aquatic environment of metalsmetal compounds

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MERAG Fact sheet Classification for effect on
the aquatic environment of metals/metal compounds

• Hugo Waeterschoot (ENIA), Marnix Vangheluwe
  (EURAS),
• Bill Adams and Katrien Delbeke (ICA), Frank Van
  Assche (IZA)
• and Violaine Verougstraete (Eurometaux)

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MERAG

• MERAG
• Metal Risk Assessment Guidance Document (fact
  sheets)
• Published January 20
• International in nature and extensively reviewed
  and peer reviewed
• Objective
• Aimed at consolidation technical and scientific
  knowledge on metals which advanced significantly
  over last couple of years.
• Incorporation of new concepts and improvements
  for RA Cl L
• Bioavailability, statistical extrapolation,
• Critical Reference Surface Area
• Critical Particle Size

http//www.euras.be/merag
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Aims and presentations

• Generic Aim Review metals (compounds)
  environmental classification strategy and tools
  to provide self-classification guidance to
  industry for the future
• Presentations
• Intro raising the subjects (Hugo Waeterschoot)
• Experience with the Transformation Dissolution
  protocol (Bill Adams)
• Effects part of the env. Cll equation (Frank Van
  Assche)
• Exposure part and Classification approaches
  (Katrien Delbeke)
• Persistency/Degradation how to interpret for
  metals (compounds) (Bill Adams)
• We aim to update MERAG fact sheet and use outcome
  for RIP 3.6 and an interpretation guidance on GHS
  Cll for metals and metal compounds
• Relevancy of the ClL approach for metals is
  broader and may include many other inorganic
  materials including matrix type
  materials/preparations like alloys.

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Generic issues

• Metals are data rich
• Effects data sets how to handle them
• Metals have specific particularities
• Solubility differs for different physical forms
• Metal Surface corresponds with loading
• Need for specific approaches
• Cf. EU and OECD/GHS Classification strategy and
  testing protocols (eg Transformation dissolution
  protocol)
• Further improvements possible eg Critical
  Surface approach
• Further application of existing approaches to
  alloys

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Generic Classification strategy

• Present classification scheme well accepted
• Outstanding issues
• Further validation of Transformation dissolution
  protocol
• Guidance on the degradability term (removal
  from the water column)
• Rigid nature of the Screening (24h) test

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Classification strategy metal/metal compounds
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Data richness

• Derivation of Ecotoxicity Reference value
• Data selection
• Data aggregation
• Data treatment

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Derivation ecotoxicity reference value

• Base approach
• Data compilation reliability and relevance
• Aggregation of high quality toxicity data
• Select lowest for reference value for different
  pH classes
• Refined Tier
• Data compilation reliability and relevance
• Refined data aggregation techniques (SSDs )
• Normalisation of reference value using
  Bioavailability models
• Normalise to reference pH values (eg. 8 or 6, )

Tiered approach allowed applying refinement when
needed or data are available
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Data compilation selection
Reliability

• 1. Type of test
• 2. Description of test material methods
• 3. Description of physico-chemical test
  conditions
• 4. Chemical analysis
• 5. Concentration-effect relationship
• 6. Derivation of toxicity values

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Data compilation selection
Relevance

• 1. Biological relevance of endpoints (survival,
  growth, )
• 2. Relevancy of test substance (impurities)
• 3. Relevancy of test medium (natural vs
  artificial, TDp medium)
• 4. Relevancy of species
• endemic and non-endemic could be used
• focus to standard species in classification
• 5. Relevancy of exposure duration
• 6. Acclimation/adaptation
• relevancy of culture medium

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Data aggregation classical way

• 1. Grouping of data
• grouping per species/endpoint
• grouping according to physico-chemical properties
  such as pH (or normalized using bioavailability
  models)
• 2. Geometric mean
• 3. Lowest value based on different
  endpoints/species
• 4. Most sensitive life stage

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Refined Data aggregation
ERV HC5
Derivation of ERV-SSD approach
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Normalisation of effects data
Algae tox data pH 6b
Daphnids tox data pH 6b
Fish tox data pH 6a
Algae tox data pH 6a
Daphnids tox data pH 6a
Fish tox data pH 6b
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Refined approaches

• Critical surface approach
• Dose surface for inorganics !
• Allows to classify any powder size based on the
  intrinsic property solubility
• Enables self classification for massives, powders
• And Limits potential testing needs under REACH
• Application of the TDp to
• Other inorganics
• Originally developed for metals and sparingly
  soluble metals, but can be extended to other
  matrix type inorganics like alloys

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Critical surface approach
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Application to matrix type substances like alloys

• Hazards of Matrix type substances are different
  as of the constituents !
• Aquatic toxicity driven by dissolved and
  Bioavailable fraction
• TDp allows for measuring the dissolved fraction
  for the different components
• Testing on the dissolution medium

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Classification strategy metal/metal compounds (A)
Classification of soluble form
Default classification metals and SSMC
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Classification strategy metal/metal compounds (B)