Materials for reclaim, precious metal production by-products

Endpoint summary

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 "Materials for reclaim, precious metal production by-products" 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

"Materials for reclaim, precious metal production by-products" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, precious metal production by-products" 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 "Materials for reclaim, precious metal production by-products".

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:

"Materials for reclaim, precious metal production by-products" (Reclaim 2 - Reclaim 4) possesses skin sensitisation potential in accordance with Guidance on the application of the CLP criteria, Version 4.0 - November 2013. Hence, "Materials for reclaim, precious metal production by-products" (Reclaim 2 - Reclaim 4) 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 "Materials for reclaim, precious metal production by-products", 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 metal production by-products" 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 four different grades of "Materials for reclaim, precious metal production by-products" (Reclaim 1 – Reclaim 4) 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 Sens. 1 (Reclaim 2 -4)) and two C&L entries for respiratory sensitisation (no C&L (Reclaim 1 -3) and respiratory sensitiser Resp.Sens. 1 (Reclaim 4)) 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 "Materials for reclaim, precious metal production by-products" is available. Since, "Materials for reclaim, precious metal production by-products" composition profile 2 till composition profile 3 (Reclaim 2 - Reclaim 3) contains at least one constituent ≥ 1 % (i.e., nickel) 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 "Materials for reclaim, precious metal production by-products" - composition profile 1 (Reclaim 1 ) and composition profile 4 (Reclaim 4), please refer to the IUCLID endpoint summaries "sensitisation - Materials for reclaim, precious metal production by-products (Reclaim1) and "sensitisation - Materials for reclaim, precious metal production by-products (Reclaim 4).

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 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 "Materials for reclaim, precious metal production by-products" 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

"Materials for reclaim, precious metal production by-products" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Materials for reclaim, precious metal production by-products" 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 "Materials for reclaim, precious metal production by-products".

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:

"Materials for reclaim, precious metal production by-products" (Reclaim 1 - Reclaim 3) does not contain any constituent ≥ 0.1 % (w/w) that induces 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 "Materials for reclaim, precious metal production by-products", 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 "Materials for reclaim, precious metal production by-products" is available. Since, "Materials for reclaim, precious metal production by-products" (Reclaim 2 - Reclaim 3) does not contain any constituent ≥ 0.1 % (w/w) that itself is classified for respiratory sensitisation, the substance must not be classified as respiratory sensitiser.

Justification for classification or non-classification

Skin sensitisation

"Materials for reclaim, precious metal production by-products" (Reclaim 2 - Reclaim 3) possesses a skin sensitisation potential in accordance with Regulation (EC) 1272/2008. Hence, "Materials for reclaim, precious metal production by-products" (Reclaim 2 - Reclaim 3) does require classification as skin sensitiser in accordance with Regulation (EC) 1272/2008 Cat. 1 (H317).

Respiratory sensitisation

Furthermore, "Materials for reclaim, precious metal production by-products" (Reclaim 2 - Reclaim 3) does not contain any constituent ≥ 0.1 % (w/w) that itself is classified for respiratory sensitisation. Hence, the substance must not be classified as respiratory sensitiser in accordance with Regulation (EC) 1272/2008.