Lead bullion, Platinum Group Metals rich

Carcinogenicity

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" does not contain any constituent ≥ 0.1 % which is classified as a Carc. 1A or Carc. 1B carcinogen but contains ≥ 1 % nickel powder, respectively, that is classified as a Carc. 2 carcinogen. Hence, "Lead bullion, Platinum Group metals rich" must be classified to induce cancer (Carc. 2). 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity

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 considering carcinogenicity of "Lead bullion, Platinum Group metals rich" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.6.3.1.1 “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

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:

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively. "Lead bullion, Platinum Group metals rich2 does not contain any constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B but constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., nickel powder). Hence "Lead bullion, Platinum Group metals rich" is considered to induce cancer and must be classified as carcinogenic Carc. 2 (H351), 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:

no adverse effect observed

Carcinogenicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

carcinogenicity

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 considering carcinogenicity of "Lead bullion, Platinum Group metals rich" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.6.3.1.1 “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

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:

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively. "Lead bullion, Platinum Group metals rich2 does not contain any constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B but constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., nickel powder). Hence "Lead bullion, Platinum Group metals rich" is considered to induce cancer and must be classified as carcinogenic Carc. 2 (H351), 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

Carcinogenicity: via dermal route

Link to relevant study records

Reference

Endpoint:

carcinogenicity

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 considering carcinogenicity of "Lead bullion, Platinum Group metals rich" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.6.3.1.1 “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

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:

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively. "Lead bullion, Platinum Group metals rich2 does not contain any constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B but constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., nickel powder). Hence "Lead bullion, Platinum Group metals rich" is considered to induce cancer and must be classified as carcinogenic Carc. 2 (H351), 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:

no adverse effect observed

Justification for classification or non-classification

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively. "Lead bullion, Platinum Group metals rich" does not contain any constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B but constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., nickel powder). Hence, "Lead bullion, Platinum Group metals rich" is considered to induce cancer and does require classification as carcinogenic Carc. 2 (H351), in accordance with Regulation (EC) 1272/2008.

Additional information

Substance specific information for the UVCB substance "Lead bullion, Platinum Group metals rich" is not available for the endpoint "Carcinogenicity". 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 carcinogen that trigger classification of the mixture” and respective rules of Regulation (EC) 1272/2006 section 3.6.3.1 “Classification of mixtures when data are available for all ingredients or only for some ingredients 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., carcinogenic Carc. 2) for carcinogenicity were calculated.

Justification for selection of carcinogenicity via inhalation route endpoint:
i.e., nickel powder