Waste solids, precious metal refining

Carcinogenicity

Description of key information

"Material for reclaim, precious metal with or without support" with the composition profiles 1 - 3 (Reclaim 1 - Reclaim 3) contains constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (NiO) and constituents ≥ 0.1 % classified for carcinogenicity Carc. 1B (Cd). 

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 "Material for reclaim, precious metal with or without support" 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

„Material for reclaim, precious metal with or without support“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Material for reclaim, precious metal with or without support“ 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 “Material for reclaim, precious metal with or without support”.

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:

Material for reclaim, precious metal with or without support (Reclaim 1 - Reclaim 3):

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. "Material for reclaim, precious metal with or without support" with the composition profiles 1 - 3 (Reclaim 1 - Reclaim 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (NiO) and constituents ≥ 0.1 % classified for carcinogenicity Carc. 1B (Cd). Hence, "Material for reclaim, precious metal with or without support" (Reclaim 1 - Reclaim 3) is considered to induce cancer and must be classified as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Material for reclaim, precious metal with or without support", 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 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 "Material for reclaim, precious metal with or without support" 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

„Material for reclaim, precious metal with or without support“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Material for reclaim, precious metal with or without support“ 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 “Material for reclaim, precious metal with or without support”.

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:

Material for reclaim, precious metal with or without support (Reclaim 1 - Reclaim 3):

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. "Material for reclaim, precious metal with or without support" with the composition profiles 1 - 3 (Reclaim 1 - Reclaim 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (NiO) and constituents ≥ 0.1 % classified for carcinogenicity Carc. 1B (Cd). Hence, "Material for reclaim, precious metal with or without support" (Reclaim 1 - Reclaim 3) is considered to induce cancer and must be classified as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Material for reclaim, precious metal with or without support", 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 "Material for reclaim, precious metal with or without support" 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

„Material for reclaim, precious metal with or without support“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Material for reclaim, precious metal with or without support“ 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 “Material for reclaim, precious metal with or without support”.

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:

Material for reclaim, precious metal with or without support (Reclaim 1 - Reclaim 3):

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. "Material for reclaim, precious metal with or without support" with the composition profiles 1 - 3 (Reclaim 1 - Reclaim 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (NiO) and constituents ≥ 0.1 % classified for carcinogenicity Carc. 1B (Cd). Hence, "Material for reclaim, precious metal with or without support" (Reclaim 1 - Reclaim 3) is considered to induce cancer and must be classified as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Material for reclaim, precious metal with or without support", 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

Material for reclaim, precious metal with or without support (Reclaim 1 - Reclaim 3):

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. "Material for reclaim, precious metal with or without support" with the composition profiles 1 - 3 (Reclaim 1 - Reclaim 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (NiO) and constituents ≥ 0.1 % classified for carcinogenicity Carc. 1B (Cd, Reclaim 3 only). Hence, "Material for reclaim, precious metal with or without support" (Reclaim 1 -

Reclaim 3) is considered to induce cancer and must be classified as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Additional information

Substance specific information for the UVCB substance "Materials for reclaim, precious metals with or without support" 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 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 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.

In total three different grades of "Materials for reclaim, precious metals with or without support" (Reclaim 1 - Reclaim 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Materials for reclaim, precious metals with or without support" one C&L entry (carcinogenic Cat. 1) for carcinogenicity was calculated.

Justification for selection of carcinogenicity via inhalation route endpoint:
i.e. NiO