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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

No information on animal testing of “Lead bullion, Platinum Group metals rich” is available. However, “Lead bullion, Platinum Group metals rich” with a lead powder and nickel powder content of ≥ 1 % is considered to be toxic to specific target organs following repeated dosing via the oral route and meets classification criteria for STOT-RE 1; H372.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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 "Lead bullion, Platinum Group metals rich" 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

Lead bullion, Platinum Group metals rich refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Lead bullion, Platinum Group metals rich 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 Lead bullion, Platinum Group metals rich 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.

Conclusions:
Classification of UVCB substances as being toxic to specific target organs is based on the presence of one or more constituents ≥ 1 % classified for STOT RE 1 and the presence of one or more constituents ≥ 10 % classified for STOT RE 2. Since, "Lead bullion, Platinum Group metals rich" contains ≥ 1 % lead powder and nickel powder classified as STOT RE 1, "Lead bullion, Platinum Group metals rich2 meets the classification criteria for STOT RE 1 (H372) as required in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Lead bullion, Platinum Group metals rich", 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
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 "Lead bullion, Platinum Group metals rich" 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

Lead bullion, Platinum Group metals rich refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Lead bullion, Platinum Group metals rich 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 Lead bullion, Platinum Group metals rich 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.

Conclusions:
Classification of UVCB substances as being toxic to specific target organs is based on the presence of one or more constituents ≥ 1 % classified for STOT RE 1 and the presence of one or more constituents ≥ 10 % classified for STOT RE 2. Since, "Lead bullion, Platinum Group metals rich" contains ≥ 1 % lead powder and nickel powder classified as STOT RE 1, "Lead bullion, Platinum Group metals rich" meets the classification criteria for STOT RE 1 (H372) as required in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Lead bullion, Platinum Group metals rich", 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Substance specific information for the UVCB substance "Lead bullion, Platinum Group metals rich" 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 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 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. This approach has been presented and discussed with ECHA in several meetings.

For "Lead bullion, Platinum Group metals rich" one C&L entry (i.e., STOT RE 1) for repeated dose toxicity were calculated.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
i.e., lead powder

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
i.e., nickel powder

Justification for classification or non-classification

Classification of UVCB substances as being toxic to specific target organs is based on the presence of one or more constituents ≥ 1 % classified for STOT RE 1 and the presence of one or more constituents ≥ 10 % classified for STOT RE 2. Since, “Lead bullion, Platinum Group metals rich” contains ≥ 1% lead powder and nickel powder classified as STOT RE 1 (self-classification), “Lead bullion, Platinum Group metals rich” meets classification criteria for STOT RE 1 and requires labelling with H372 (causes damage to organs) as required in accordance with Regulation (EC) 1272/2008.