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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- predicted 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:
- Genetic toxicity 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
- Type of assay:
- other: prediction from hazard class
- Remarks on result:
- not measured/tested
- Conclusions:
- Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified as Mutagenic Cat.2 - H341.
- Executive summary:
The study provided a conservative estimate, 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.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- predicted from hazard class
- Type of information:
- calculation (if not (Q)SAR)
- 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:
- Mutagenic toxicity 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
- Type of assay:
- other: prediction from hazard class
- Remarks on result:
- not measured/tested
- Conclusions:
- Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for as mutagenic Cat.2 - H341.
- Executive summary:
The study provided a conservative estimate, 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.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- predicted from hazard class
- Type of information:
- calculation (if not (Q)SAR)
- 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:
- Mutagenic toxicity 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
- Type of assay:
- other: prediction from hazard class
- Remarks on result:
- not measured/tested
- Conclusions:
- Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for as mutagenic Cat.2 - H341.
- Executive summary:
The study provided a conservative estimate, 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.
Referenceopen allclose all
According to MeClas the substance is classified as Mutagenic Cat.2 - H341.
According to MeClas the substance is classified Mutagenic Cat. 2 - H341.
According to MeClas the substance is classified Mutagenic Cat. 2 - H341.
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- calculation (if not (Q)SAR)
- 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:
- Genetic toxicity 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
- Type of assay:
- other: prediction from hazard class
- Sex:
- not specified
- Genotoxicity:
- not specified
- Toxicity:
- not specified
- Conclusions:
- Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified as Mutagenic Cat.2 - H341.
- Executive summary:
The study provided a conservative estimate, 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.
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- calculation (if not (Q)SAR)
- 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:
- Genetic toxicity 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
- Type of assay:
- other: prediction from hazard class
- Sex:
- not specified
- Genotoxicity:
- not specified
- Toxicity:
- not specified
- Conclusions:
- Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified as Mutagenic Cat.2 - H341.
- Executive summary:
The study provided a conservative estimate, 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.
Referenceopen allclose all
According to MeClas the substance is classified as Mutagenic Cat.2 - H341.
According to MeClas the substance is classified as Mutagenic Cat.2 - H341.
Additional information
Substance specific information for the UVCB substance " Matte leaching residue" is not available for the endpoint "Genetic Toxicity". 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 it was agreed within the consortium to use the classification information from the individual constituents and calculate the resulting classification by using the “generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture.” and respective rules of Regulation (EC) 1272/2006 section 3.5.3.1. “Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture” with the MeClas tool.
In total three different “ Matte leaching residue” were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. However, for “ Matte leaching residue" only one C&L entry (i.e., mutagen Muta. 2) for genetic toxicity was generated, since all composition profiles contains nickel sulfate ≥ 1% relevant for C&L as Muta. 2.
Justification for selection of genetic toxicity endpoint
i.e., nickel sulfate
Short description of key information:
No information on animal testing of “ Matte leaching residue” is
available. “ Matte leaching residue” contains one constituent ≥ 1 %
(w/w) classified as mutagen Muta. 2 (NiSO4), but no constituent ≥ 0.1 %
(w/w) classified as mutagen Muta. 1A/B. In conclusion, “ Matte leaching
residue” requires classification as Muta. 2 (H341) in accordance with
Regulation (EC) 1272/2008.
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
“ Matte leaching residue” contains one constituent ≥ 1 % (w/w) classified as mutagen Muta. 2 (NiSO4), but no constituent ≥ 0.1 % (w/w) classified as mutagen Muta. 1A/B. In conclusion,“ Matte leaching residue” requires classification as Muta. 2 (H341) 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.
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