Registration Dossier

No information on animal testing of Flue dust, precious metal refining is available. However, Flue dust, precious metal refining composition profile 1 till composition profile 3 (Flue dust 1 – Flue dust 3) contain constituents ≥ 0.1 % which are classified as a Carc. 1A carcinogen (As2O3, NiSO4). Hence, Flue dust 1 – Flue dust 3 must be classified to induce cancer (Carc. 1A, H350).

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 genotoxicity of "Flue dust, precious metal refining" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.6.3.1 “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

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.

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. "Flue dust, precious metal refining" with the composition profiles 1 – 3 (Flue dust 1 – Flue dust 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (, Flue dust 1 and Flue dust 3: NiSO4; Flue dust 2: As2O3) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds - Annex VI of Regulation (EC) 1272/2008 + self-classification for carcinogenicity). Hence, Flue dust 1 – Flue dust 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 "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.

Endpoint conclusion:

adverse effect observed

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 genotoxicity of "Flue dust, precious metal refining" was determined by using the “Classification criteria for mixtures” of Regulation (EC) 1272/2006 section 3.6.3.1 “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

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.

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. "Flue dust, precious metal refining" with the composition profiles 1 – 3 (Flue dust 1 – Flue dust 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (, Flue dust 1 and Flue dust 3: NiSO4; Flue dust 2: As2O3) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds - Annex VI of Regulation (EC) 1272/2008 + self-classification for carcinogenicity). Hence, Flue dust 1 – Flue dust 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 "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.

Endpoint conclusion:

adverse effect observed

Endpoint conclusion:

no adverse effect observed

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.

Flue dust, precious metal refining with the composition profiles 1 – 3 (Flue dust 1 – Flue dust 3) does contain constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (Flue dust 1 and Flue dust 3: NiSO4; Flue dust 2: As2O3) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds - Annex VI of Regulation (EC) 1272/2008 + self-classification for carcinogenicity). Hence, Flue dust 1 – Flue dust 3 is considered to induce cancer and must be classified as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Substance specific information for the UVCB substance "Flue dust, precious metal refining" 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 Flue dust, precious metal refining (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 (carcinogenicity Carc. 1A) for carcinogenicity was calculated.

Justification for selection of carcinogenicity via oral route endpoint:
Flue dust 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:
Flue dust 1 and Flue dust 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.