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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 310-050-8 | CAS number: 102110-49-6
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- other: prediction from hazard class
- 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
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Skin sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.
- GLP compliance:
- no
- Remarks:
- other quality assurance was applied
- Remarks on result:
- not measured/tested
- Remarks on result:
- not measured/tested
- Remarks on result:
- not measured/tested
- Conclusions:
- The study provides a conservative estimate of the Acute Oral toxicity. The substance is classified as Skin sensitiser Cat 1 - H317.
- Executive summary:
The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample.
Validity of the model used:
1. Defined endpoint: the endpoint is a REACH compliant defined endpoint
2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria
3. Applicability domain: applicable to classify complex metal containing materials.
4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.
Reference
According to MeClas the substance is classified as Skin sensitiser Cat 1 - H317.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Substance specific information for the UVCB substance“Matte leaching residue"is not available for the endpoint "Sensitisation". In order to meet the requirements for Annex VII till Annex X of Regulation (EC) 1907/2006, read across information from any constituents being relevant needs to be included. Due to the high number of constituents and variability in C&L of these constituents it was decided to use the classification information from the individual constituents and to calculate the resulting classification by using the generic concentration limits of ingredients of the mixture classified as skin sensitizer that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.4.3.3 “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.
Calculation of C&L for composition profile 1 – 3 of“Matte leaching residue" results only inone C&L entry (i.e., Skin Sens. 1) for “Skin Sensitisation”.
Migrated from Short description of key information:
No information on animal testing of “Matte leaching residue" is available. Since, “Matte leaching residue" contains a constituent ≥ 0.1 % (i.e., cobalt and/or nickel sulfate) that may cause skin sensitisation (Skin Sens. 1); the substance must be classified as being a skin sensitiser “Skin Sens. 1 (H317)”. It is noted that no sub-categorisation was performed.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation, other
- Remarks:
- other: prediction from hazard class
- 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
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Respiratory sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.
- GLP compliance:
- no
- Remarks:
- other quality assurance was applied
- Conclusions:
- The study provides a conservative estimate of the Respiratory Sensitisation. The substance is classified as Respiratory sensitiser Cat.1 - H334.
- Executive summary:
The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample.
Validity of the model used:
1. Defined endpoint: the endpoint is a REACH compliant defined endpoint
2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria
3. Applicability domain: applicable to classify complex metal containing materials.
4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.
Reference
According to MeClas the substance is classified as Respiratory sensitiser Cat.1 - H334.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Substance specific information for the UVCB substance“Matte leaching residue"is not available for the endpoint "Sensitisation". In order to meet the requirements for Annex VII till Annex X of Regulation (EC) 1907/2006, read across information from any constituents being relevant needs to be included. Due to the high number of constituents and variability in C&L of these constituents it was decided to use the classification information from the individual constituents and to calculate the resulting classification by using the generic concentration limits of ingredients of the mixture classified as respiratory sensitiser that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.4.3.3 “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.
Calculation of C&L for composition profile 1 – 3 of “Matte leaching residue" results only inone C&L entry (i.e., Respir. Sens. 1) for “Respiratory Sensitisation”.
Migrated from Short description of key information:
No information on animal testing of “Matte leaching residue" is available. “Matte leaching residue" contains at least one constituent ≥ 0.1 % (w/w) (i.e., cobalt and/or nickel sulfate) that may cause respiratory sensitisation “Resp.Sens. 1” (H334). Hence, the UVCB meets classification criteria for respiratory sensitisation “Resp.Sens. 1” (without sub-categorising) in accordance with Regulation (EC) 1272/2008.
Justification for classification or non-classification
Skin sensitisation
“Matte leaching residue”possesses a skin sensitisation potential and requires classification as skin sensitiser in accordance with Regulation (EC) 1272/2008 Skins. Sens. 1 (H317: May cause an allergic skin reaction.).
Respiratory sensitisation
Furthermore,“Matte leaching residue” contains at least one constituent ≥ 0.1 % (w/w) (i.e., cobalt and/or nickel sulfate) that may cause respiratory sensitisation Resp. Sens.1 (H334). Hence, the substance meets classification criteria for respiratory sensitisation “Resp.Sens. 1” (without sub-categorising) and requires labelling with H334 (may cause allergy or asthma symptoms or breathing difficulties if inhaled) in accordance with Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.