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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
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 skin sensitisation 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 3.4.3.3.1 “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
Type of study:
other: calculation

"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.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
"Material for reclaim, precious metal with or without support" (Reclaim 2 - Reclaim 3) possesses skin sensitisation potential (Co, NiO, Pd compounds) in accordance with Guidance on the application of the CLP criteria, Version 4.0 - November 2013. Hence, "Material for reclaim, precious metal with or without support" (Reclaim 2 - Reclaim 3) does require classification as skin sensitiser Skin Sens. 1 (H317) 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 (sensitising)
Additional information:

Substance specific information for the UVCB substance "Materials for reclaim, precious metals with or without support" is not available for the endpoint "Sensitisation". 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.

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 Reclaim two C&L entries for Skin Sensitisation (no classification (Reclaim 1) and skin sensitising Skin Sens. 1 (Reclaim 2 - 3)) were calculated. Each group is described in a separate endpoint study record and endpoint summary.


Migrated from Short description of key information:
No information on animal testing of "Material for reclaim, precious metal with or without support" is available. Since, "Material for reclaim, precious metal with or without support" composition profile 2 and 3 (Reclaim 2 and Reclaim 3) contains at least one constituent ≥ 1 % (i.e., Co, NiO, Pd compounds) that itself is classified for skin sensitisation; the substance must be classified as being a skin sensitiser, Skin Sens. 1 (H317). It is noted that no sub-categorisation was included.

For information on C&L for "Material for reclaim, precious metal with or without support" - composition profile 1 (Reclaim 1 ), please refer to the IUCLID endpoint summaries "sensitisation -Material for reclaim, precious metal with or without support (Reclaim1).

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation
Remarks:
other:
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 respiratory sensitisation 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 3.4.3.3.1 “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

"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.

Interpretation of results:
sensitising
Conclusions:
"Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) contains at least one constituent (Co) ≥ 0.1 % (w/w) that may cause respiratory sensitisation Resp.Sens. 1A (H334). Hence, the substance must be classified as respiratory sensitiser Resp.Sens. 1 (H334) 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 (sensitising)
Additional information:

Substance specific information for the UVCB substanceMaterials for reclaim, precious metals with or without supportis not available for the endpoint "Sensitisation". 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.

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 Reclaim two C&L entries for respiratory sensitisation (no C&L (Reclaim 1) and respiratory sensitiser Cat. 1 (Reclaim 2 and 3)) were calculated. Each group is described in a separate endpoint study record and endpoint summary.


Migrated from Short description of key information:
No information on animal testing of "Material for reclaim, precious metal with or without support" is available. "Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) contains at least one constituent (Co) ≥ 0.1 % (w/w) that is classified for respiratory sensitisation Resp. Sens. 1A (H334). Hence, the substance must be classified as respiratory sensitiser Resp. Sens. 1 (H334) in accordance with Regulation (EC) 1272/2008.

Justification for classification or non-classification

Skin sensitisation

"Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) possesses skin sensitisation potential in accordance with Guidance on the application of the CLP criteria, Version 4.0 - November 2013. Hence, "Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) does require classification as skin sensitiser Skins. Sens. 1 (H317) in accordance with Regulation (EC) 1272/2008 .

Respiratory sensitisation

Furthermore, "Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) contains at least one constituent (Co) ≥ 0.1 % (w/w) that is classified for respiratory sensitisation Resp.Sens. 1A (H334). Hence, the substance must be classified as respiratory sensitiser Resp.Sens. 1 (H334) in accordance with Regulation (EC) 1272/2008.

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