Registration Dossier

Administrative data

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 "Residues, precious metal refining cementation" 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

„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.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
"Residues, precious metal refining cementation" possesses a skin sensitisation potential in accordance with Guidance on the application of the CLP criteria, Version 4.0 - November 2013. Hence, "Residues, precious metal refining cementation" (Residues 1 and Residues 2) does require classification as skin sensitiser in accordance with Regulation (EC) 1272/2008 Skin Sens. 1 (H317).
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 (sensitising)
Additional information:

Substance specific information for the UVCB substance "Residues, precious metal refining cementation" 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 two different grades of "Residues, precious metal refining cementation" (Residues 1 – 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 one C&L entry for Skin Sensitisation (Skin Sens. 1) was calculated.

Migrated from Short description of key information:
No information on animal testing of "Residues, precious metal refining cementation" is available. Since, Residues composition profile 1 (Residues 1) contains a constituent ≥ 0.1 % (i.e., nickel) that may cause skin sensitisation (Skin Sens. 1A); the substance must be classified as being a skin sensitiser, Skin Sens. 1 (H317). It is noted that no sub-categorisation was performed.

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 "Residues, precious metal refining cementation" (Residues 1) 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

„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.

Interpretation of results:
not sensitising
Conclusions:
"Residues, precious metal refining cementation" (Residues 1) does not contain any constituent ≥ 0.1 % (w/w) that may cause respiratory sensitisation. Hence, the substance must not be classified as respiratory sensitiser 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:
no adverse effect observed (not sensitising)
Additional information:

Substance specific information for the UVCB substance "Residues, precious metal refining cementation" 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 two different grades of "Residues, precious metal refining cementation" (Residues 1 – 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 two C&L entries for respiratory sensitisation (no C&L and respiratory sensitiser Resp. Sens. 1) 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 "Residues, precious metal refining cementation" is available. Since, "Residues, precious metal refining cementation" (Residues 1) does not contain any constituent ≥ 0.1 % (w/w) that may cause respiratory sensitisation, the substance must not be classified as respiratory sensitiser.

Justification for classification or non-classification

Skin sensitisation

"Residues, precious metal refining cementation" (Residues 1) possesses a skin sensitisation potential in accordance with Guidance on the application of the CLP criteria, Version 4.0 - November 2013. "Hence, Residues, precious metal refining cementation" (Residues 1) does require classification as skin sensitiser in accordance with Regulation (EC) 1272/2008 Skin Sens. 1 (H317).

Respiratory sensitisation

Furthermore, "Residues, precious metal refining cementation" (Residues1) does not contain any constituent ≥ 0.1 % (w/w) that may cause respiratory sensitisation. Hence, the substance must not be classified as respiratory sensitiser in accordance with Regulation (EC) 1272/2008.