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:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for skin sensitisation of "Slags, precious metal refining" 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

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
"Slags, precious metal refining" - composition profile 1, applying the rules set forth in Regulation (EC) 1272/2008, possesses a skin sensitisation potential. Hence, "Slags, precious metal refining" - composition profile 1 requires classification as skin sensitiser, Skin Sens. 1 and requires labelling with H317 (May cause an allergic skin reaction). No further sub-categorising was performed.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Slags, 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
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Substance specific information for the UVCB substance "Slags, precious metal refining" 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.Due to the high number of constituents and variability in C&L of these constituents it was decided to use the classification information from the individual constituents and to calculate the resulting classification by usingthe generic concentration limits of ingredients of the mixture classified as a specific target organ toxicant that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.4.3.2 “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool.This approach has been presented and discussed with ECHA in several meetings.

In total, two different grades of " Slags, precious metal refining" (composition profile 1 – composition profile 2) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. Thus, for " Slags, precious metal refining" two C&L entries for skin sensitisation (i.e., skin sensitisation Skin Sens. 1 and no C&L) and one C&L entry (i.e., no C&L) for respiratory sensitisation were generated. 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 "Slags, precious metal refining" is available. Since, "Slags, precious metal refining" - composition profile 1 constituent ≥ 1 % (i.e., nickel) that releases skin sensitisation; 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 usedcalculation tool MeClas (www.meclas.eu) is used
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for respiratory sensitisation of "Slags, precious metal refining" 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

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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.

Interpretation of results:
not sensitising
Conclusions:
"Slags, precious metal refining" does not contain any constituent ≥ 0.1 % (w/w) that releases respiratory sensitization (Resp. Sens. 1 without further sub-categorisation). 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 "Slags, 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
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
No information on animal testing of "Slags, precious metal refining" is available. Since, "Slags, precious metal refining" - composition 1 does not contain any constituent ≥ 0.1 % (w/w) that releases respiratory sensitization (Skin Sens. 1 without further sub-categorisation), no classification as respiratory sensitisation is required for the UVCB substance.

Justification for classification or non-classification

Skin sensitisation

"Slags, precious metal refining" - composition profile 1 possesses a skin sensitisation potential in accordance with Guidance on the application of the CLP criteria, Version 4.0 - November 2013. Hence, "Slags, precious metal refining" - composition profile 1 requires classification as skin sensitiser, Skin Sens. 1 in accordance with Regulation (EC) 1272/2008 and requires labelling with H317 (May cause an allergic skin reaction).

 

Respiratory sensitisation

Furthermore, "Slags, precious metal refining" - composition profile 1 does not contain any constituent ≥ 0.1 % (w/w) that releases respiratory sensitisation. Hence, "Slags, precious metal refining" - composition profile 1 must not be classified as respiratory sensitiser in accordance with Regulation (EC) 1272/2008.