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EC number: 308-496-3 | CAS number: 98072-44-7 The dust obtained from the refining of materials from primary and secondary sources containing gold, iridium, osmium, palladium, platinum, rhenium, ruthenium and silver. Composed primarily of lead with traces of other metals.
- 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
No information on animal testing of Flue dust is available. However, "Flue dust, precious metal refining" (Flue dust 1 - Flue dust 3) with a lead and lead compound content of ≥ 0.5% is considered to be toxic to specific target organ following repeated dose application via oral route and should be labelled with STOT-RE 1; H372 (specific concentration limits of lead compounds; see "justification for classification and non-classification" below), in accordance with Regulation (EC) 1272/2008.
Further, "Flue dust, precious metal refining" (Flue dust 1 and Flue dust 3) contains >0.1 % nickel sulfate in the composition profile. Nickel sulfate meets the classification criteria for STOT RE 1 via the inhalation route and is therefore included in C&L calculation with MeClas. Flue dust composition profile 2 contains up to 10 % NiO which is also classified as STOT-RE 1.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- 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: calculation tool MeClas (www.meclas.eu) is used
- 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:
- The C&L for toxic to specific target organ after repeated dose application of Flue dust was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).
- GLP compliance:
- no
- Critical effects observed:
- not specified
- Conclusions:
- General note:
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification are as follows:
STOT RE 1; H372: C ≥ 0.5%
STOT RE 2; H373: 0.05% ≤ C < 0.5%
Therefore, the following C&L driver is identified for Flue dust, precious metal refining (Flue dust 1 - Flue dust 3) for the oral route:
(i):classification driver lead and lead compound (oral route, systemic effects)
Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and/or on the presence of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since Flue dust, precious metal refining with the composition profiles 1 - 3 (Flue dust 1 - Flue dust 3) include lead/lead compounds with a content >=0.5%, Flue dust, precious metal refining (Flue dust 1 - Flue dust 3) must be classified as STOT-RE 1 (oral route) in accordance with Regulation (EC) 1272/2008. - Executive summary:
The described MeClas-based-calculation provides a conservative estimate of toxicological effects of Flue dust, precious metal refining, derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.
Reference
Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal refining may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of Flue dust, precious metal refining.
MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.
From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.
The following data were used as input of MeClas:
1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.
2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- 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: calculation tool MeClas (www.meclas.eu) is used
- 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:
- The C&L for toxic to specific target organ after repeated dose application of Flue dust was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.9.3.4.1 “Classification of mixtures when data are available for all components or only for some components of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).
- GLP compliance:
- no
- Critical effects observed:
- not specified
- Conclusions:
- General note:
According to the self-classification of nickel sulfate the specific concentration limits (SCL) for STOT RE classification (inhalation) are as follows:
STOT RE 1; H372: C ≥ 1%
STOT RE 2; H373: 0.1% ≤ C < 1%
Therefore, the following C&L driver is identified for "Flue dust, precious metal refining" (Flue dust 1 - Flue dust 3) for the inhalation route:
(i):classification driver: nickel sulfate (inhalation route, local effects)
(II) classification driver: nickel oxide (inhalation route, local effects)
Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and/or on the presence of a constituent ≥ 10 % classified as STOT-RE 2, respectively. Since "Flue dust, precious metal refining" with the composition profiles 1 and 3 (Flue dust 1 and Flue dust 3) include nickel sulfate with a content >=1%, Flue dust, precious metal refining (Flue dust 1 and Flue dust 3) must be classified with regard to the described SCL values as STOT-RE 1 (inhalation route) in accordance with Regulation (EC) 1272/2008.
Flue dust 2 may contain 1 - 10% NiO and thus has to be classified for STOT-RE 1 (inhalation route) as well in accordance with Regulation (EC) 1272/2008. - Executive summary:
The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Flue dust, precious metal refining", derived on basis of the mixture C&L rules set forth in Regulation (EC) 1272/2008 using mineralogical information from a representative/worst case sample.
Reference
Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal refining may contribute (as 'relevant' component) to the UVCB toxicity. With knowledge of the composition, mineralogical information and knowledge of corresponding toxicity of the various chemical species, the respective mixture rules in accordance with Regulation (EC) 1272/2008 are used to calculate the C&L of Flue dust, precious metal refining.
MeClas was used to automatically calculate the classification of the UVCB substance. The calculation tool is based on a database containing the human and environmental hazard information for each component relevant for classification. The information on the representative mineralogical composition (distribution pattern for each constituent of the UVCB substance) is incorporated into MeClas as well.
From the derived hazard category (output of MeClas) the corresponding human health (HH) toxicity value was deduced.
The following data were used as input of MeClas:
1. Classification from individual components according to Annex VI of the CLP regulation (Regulation (EC) 1272/2008) and the 2nd ATP to this regulation, unless additional information on self-classification was used.
2. Percentage of the components in the UVCB: individual total element concentrations (percentages based on total substance amount) were recalculated into percentage of the classified chemical species (i.e. substance), taking into account the distribution pattern of the respective element in its present various mineral forms if such information was available.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Substance specific information for the UVCB substance "Flue dust, precious metal refining" is not available for the endpoint "Repeated Dose 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 the mixture classified as a specific target organ toxicant that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.9.3.4.“Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool.
In total three different "Flue dust, precious metal refining" grades (Flue dust 1 – Flue dust 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Flue dust, precious metal refining" one C&L entry (STOT RE 1, oral and inhalation rout) for repeated dose toxicity were calculated.
Justification for classification or non-classification
General notes:
According to the self-classification of lead compounds the specific concentration limits (SCL) for STOT RE classification (oral) are as follows:
STOT RE 1; H372: C ≥ 0.5 %
STOT RE 2; H373: 0.05 % ≤ C < 0.5 %
According to the self-classification of nickel sulfate the specific concentration limits (SCL) for STOT RE classification (inhalation) are as follows:
STOT RE 1; H372: C ≥ 1 %
STOT RE 2; H373: 0.1 % ≤ C < 1 %
Therefore, the following C&L driver were identified for Flue dust, precious metal refining:
(i) classification driver: lead and lead compounds (oral route):
(ii):classification driver: nickel sulfate (inhalation route, local effects)
(iii) classification driver: nickel oxide (inhalation route, local effects)
Flue dust – composition profile 1 - 3:
Classification of UVCB substances as being toxic to specific target organs after repeated dose application is based on the presence of a constituent ≥ 1 % classified as STOT-RE 1 and of a constituent ≥ 10 % classified as STOT-RE 2, respectively. However, for lead compounds there are specific concentration limits given for STOT RE classification assigned by the lead industry. According to Regulation (EC) 1272/2008 “specific concentration limits” should take precedence over any other concentration limits for the purpose of classification. Hence, the SCLs for lead compounds are used also for C&L of Flue dust. Since "Flue dust, precious metal refining" (Flue dust 1 - Flue dust 3) contains lead and lead compounds in concentrations relevant for C&L (lead compounds ≥0.5 %), "Flue dust, precious metal refining" meets classification criteria for STOT-RE 1 (oral route) and requires labelling with H372 (causes damage to organs), in accordance with Regulation (EC) 1272/2008.
Further, "Flue dust, precious metal refining" with the composition profiles 1 and 3 (Flue dust 1 and Flue dust 3) contains nickel sulfate with a content >=1 %. Thus, "Flue dust, precious metal refining" (Flue dust 1 and Flue dust 3) must be classified with regard to the described SCL values as STOT-RE 1 (H372, inhalation route) in accordance with Regulation (EC) 1272/2008.
Flue dust 2 may contain 1 - 10 % NiO and thus has to be classified for STOT-RE 1 (H372, inhalation route) as well 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.
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