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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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- 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:
- Reproductive 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
- Remarks on result:
- not measured/tested
- Reproductive effects observed:
- not specified
- Conclusions:
- The study provides a conservative estimate of reproductive toxicity. The analysed UVCB sample is classified as Reproductive Tox. Cat. 1A - H360.
- 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.
Reference
According to MeClas, the substance is classified as Reproductive Tox. Cat. 1A - H360.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
Substance specific information for the UVCB substance “Matte leaching residue" is not available for the endpoint "Toxicity to Reproduction" with respect to effects on fertility. 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 reproduction toxicants or for effects on or via lactation that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.7.3.1 “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 grades of “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., reproductive toxicant Repr. 1A) for
reproductive toxicity was generated, since all composition profiles
contains lead and lead compounds ≥ 0.3 % relevant for C&L as Repr. 1A.
Short description of key information:
No information on animal testing of “Matte leaching residue" is
available. However, “Matte leaching residue" contains lead and lead
compounds ≥ 0.3 % that may possess reproduction toxicity potential
(i.e., suspected of damaging fertility). However, “Matte leaching
residue" also contains nickel sulfate classified as reproductive
toxicant “Repr. 1B” (H360) with a content ≥ 0.3 %. Nevertheless, the
classification driver for “Matte leaching residue" is lead and lead
compounds that requires classification as reproductive toxicant “Repr.
1A” (H360).
Effects on developmental toxicity
Description of key information
No information on animal testing of “ Matte leaching residue" is available. However, “Matte leaching residue" contains lead and lead compounds ≥ 0.3 % that may possess reproduction toxicity potential (i.e., may damage the unborn child). However, “Matte leaching residue" also contains nickel sulfate classified as reproductive toxicant “Repr. 1B” (H360) with a content ≥ 0.3 %. Nevertheless, the classification driver for “Matte leaching residue" is lead and lead compounds that requires classification as reproductive toxicant “Repr. 1A” (H360).
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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:
- Developmental 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
- Species:
- other: MeClas calculation tool used
- Remarks on result:
- not measured/tested
- Remarks on result:
- not measured/tested
- Developmental effects observed:
- not specified
- Conclusions:
- The study provides a conservative estimate of developmental toxicity. The analysed UVCB sample is classified as Developmental Tox. Cat. 1 - H360.
- 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.
- Endpoint:
- developmental toxicity
- 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:
- Developmental 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
- Species:
- other: MeClas tool
- Remarks on result:
- not measured/tested
- Remarks on result:
- not measured/tested
- Developmental effects observed:
- not specified
- Conclusions:
- The study provides a conservative estimate of developmental toxicity. The analysed UVCB sample is classified as Developmental Tox. Cat. 1 - H360.
- 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.
Referenceopen allclose all
According to MeClas the substance is classified as Developmental Tox. Cat. 1 - H360
According to MeClas the substance is classified as Developmental Tox. Cat. 1 - H360
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- adverse effect observed
Additional information
Substance specific information for the UVCB substance “ Matte leaching residue" is not available for the endpoint "Toxicity to Reproduction" with respect to effects on developmental 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 reproduction toxicants or for effects on or via lactation that trigger classification of the mixture" and respective rules of Regulation (EC) 1272/2006 section 3.7.3.1 “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 grades of “ 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., reproductive toxicant Repr. 1A) for reproductive toxicity was generated, since all composition profiles contains lead and lead compounds ≥ 0.3 % relevant for C&L as Repr. 1A.
Justification for classification or non-classification
Reproductive toxicity classification of UVCB substances is based on the presence of a constituent ≥ 0.3 % classified for reproductive toxicity of “ Matte leaching residue" contains lead and lead compounds (Repr. 1A) and nickel sulfate (Repro. 1B) ≥ 0.3%. Hence, “ Matte leaching residue" is considered to induce reproductive toxicity, and requires classification as Repr. 1A (H360Df: may damage the unborn child, suspected of damaging fertility) based on lead and lead compounds in accordance with Regulation (EC) 1272/2008. There is not any evidence of effects on or via lactation for any constituents of “ Matte leaching residue." at a concentration ≥ 0.3 %.
Additional information
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.
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