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Toxicological information

Carcinogenicity

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Description of key information

No information on animal testing of "Residues, precious metal refining cementation" is available. However, "Residues, precious metal refining cementation" composition profile 2 (Residues 2) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (As2O3/arsenious acid, NiSO4) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds and Sb2O3, respectively). Hence, "Residues, precious metal refining cementation" (Residues 2) must be classified to induce cancer (Car. 1A). For information on C&L for "Residues, precious metal refining cementation" (Residues 1), please refer to the IUCLID endpoint summary "Carcinogenicity - Residues, precious metal refining cementation (Resides 1).

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 "Residues, precious metal refining cementation" 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

„Residues, precious metal refining cementation“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Residues, precious metal refining cementation“ 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 “Residues, precious metal refining cementation”.

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. "Residues, precious metal refining cementation" with the composition profile 2 (Residues 2) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (As2O3/arsenic acid, NiSO4) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds and Sb2O3, respectively). Hence, "Residues, precious metal refining cementation" (Residues 2) 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 "Residues, precious metal refining cementation", 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 "Residues, precious metal refining cementation" 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

„Residues, precious metal refining cementation“ is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of „Residues, precious metal refining cementation“ 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 “Residues, precious metal refining cementation”.

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. "Residues, precious metal refining cementation" with the composition profile 2 (Residues 2) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (As2O3/arsenic acid, NiSO4) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds and Sb2O3, respectively). Hence, "Residues, precious metal refining cementation" (Residues 2) 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 "Residues, precious metal refining cementation", 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

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. "Residues, precious metal refining cementation" with the composition profile 2 (Residues 2) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (As2O3/arsenic acid, NiSO4) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds and Sb2O3, respectively). Hence, "Residues, precious metal refining cementation" (Residues 2) 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 "Residues, precious metal refining cementation" 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 two different grades of "Residues, precious metal refining cementation" (Residues 1 and Residues 2) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Residues, precious metals refining cementation" two C&L entries (i.e., no C&L and carcinogenic Carc. 1A, respectively) for carcinogenicity were calculated. Each group is described in a separate endpoint study record and endpoint summary


Justification for selection of carcinogenicity via oral route endpoint:
Residues 2 with a As2O3 content ≥ 0.1 % is considered to induce cancer and meets classification criteria for Carc. 1A carcinogenicity in accordance with Regulation (EC) 1272/2008.

Justification for selection of carcinogenicity via inhalation route endpoint:
Residues 1 and Residues 3 with a NiSO4 content ≥ 0.1 % is considered to induce cancer and meets classification criteria for Carc. 1A carcinogenicity in accordance with Regulation (EC) 1272/2008.