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Diss Factsheets
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EC number: 701-480-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Remarks:
- other: calculation based on classification
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Automatic calculation with MeClas tool
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: software
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
- Principles of method if other than guideline:
- The potential of the UVCB substance to cause specific target organ toxicity following repeated exposure by oral route was established by classifying the complex metal substance according to rules for classification of mixtures for STOT RE (EU CLP guidance section 3.9.3 pg 382ff). The classification criteria (as set out in EU CLP Annex I: 3.9.3.4.1.) can be used to estimate effects derived from that classification/hazard.
- GLP compliance:
- no
- Remarks:
- other quality assurance
Test material
- Reference substance name:
- Iron silicate, copper smelting and refining
- EC Number:
- 701-480-0
- Cas Number:
- 67711-92-6
- IUPAC Name:
- Iron silicate, copper smelting and refining
- Details on test material:
- Typical across industry as defined in IUCLID 1.2;
See IUCLID Section 1.4, for company specific elemental composition; and representative sample for mineralogical information (IUCLID Section 4.23 -Outotec report)
Constituent 1
Results and discussion
Effect levels
- Dose descriptor:
- conc. level:
- Effect level:
- > 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: not specified
- Remarks on result:
- not measured/tested
- Remarks:
- calculated
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The calculated classification via rules for mixtures (Lower Tier) resulted in “STOT repeated : Category 2 ”triggered by Pb compounds at actual levels above 0,5%.
Consideration of reduced bio-accessibility of Pb (Higher Tier) resulted in” STOT repeated :: Not classified”
Based on this result, the related criteria provided theestimated dose/concentration value at or below which nosignificant toxic effects would be observed in a 90-day repeated-dose studyby oral route (see EU CLP Guidance Annex IAnnex 3.9.2.9.7,Table 3.9.3) : Oral(rat), dose concentration >100 mg/kg body weight /day
For more details, see "Human Health classification of C1 copper slag", attachment in Section7 "Summary record Toxicological information
Applicant's summary and conclusion
- Conclusions:
- Study can be used to predict the single organ toxicity effect by oral route and to determine hazard/classification of the UVCB substance
- Executive summary:
The study provided a conservative estimate of the Single organ toxicity effect, derived on basis of the Classification outcome by applying the rules for mixtures of a Typical (across industry) copper slag.
It is concluded that slag, copper smelting is not to be classified for STOT RE. Therefore estimated dose/concentration value at or below which no significant toxic effects would be observed in a 90-day repeated-dose studyis : >100 mg/kg body weight /day
The result is applicable to all copper slags that fall under the defined concentration ranges (IUCLID section 1.2) up to Pb 0.7% for granules, primary and slag powders and 0.4 % for granules secondary and slow cooled slags
Chemistry of the substance (see IUCLID section 4.23 chemical and mineralogical characterization) shows that copper slag does contain only minor constituents classified as a STOT RE Cat 1 (Ni compounds) at actual levels max 0.21 % (in representative samples and maximum levels across industry. It can be also demonstrated that copper slag contains minor constituents classified as STOT RE Cat 2 ( ex.Pb compounds) above 0.5%
In vitro measurements of bio-accessibility in solvent that resembles gastric fluid performed according to ASTM D5517.07.(pH 1.5) The fraction of metals that solubilize under these conditions can be considered as worst case determinant of bio-assesability of metals contained in the slag. Results demonstrate low relative bio-accesabilty of metals(Cu 0.06 – 0.2, Ni 0.09 – 0.33) and medium bioaccesability of Pb (0.13 – 0.74)
Furthermore, conclusions on bioavailability are supported the physical properties of the substance.
The measurements allowed to demonstrate that the maximum level of bio-accessible Pb in copper slag is below 0.5% (based on worst case release rate per different sample type)
Therefore consideration of reduced bio-accessibility of Pb will lead to No classification of copper slags for STOT repeated exposure by oral route.
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