Registration Dossier

Administrative data

Description of key information

No information on animal testing for skin and eye irritation of "Residues, precious metals refining cementation" (Residues 1) is available. The approach followed on C&L of UVCB substances as irritant or corrosive to skin and eye in case where data are available on the constituents, but not on the UVCB substance as a whole, is based on the theory of additivity (CLP guideline, section 3.2.3.2.3.2, November 2013). Since, "Residues, precious metals refining cementation" (Residues 1) does not contain any constituent ≥ 1 % (w/w) (in sum) classified as skin corrosive Skin Corr. 1A, 1B and 1C and/or ≥ 10 % (w/w) (in sum) classified as skin irritant Skin Irrit. 2, the UVCB substance "Residues, precious metals refining cementation" (Residues 1) must not be classified to possess skin irritant properties or skin corrosion.
Furthermore, since, "Residues, precious metals refining cementation" (Residues 1) does not contain any constituent ≥ 1 % (w/w) (in sum) classified as Eye Damage 1 (in sum) and ≥ 3 % (w/w) (in sum) classified as Eye Irrit. 2, the UVCB substance "Residues, precious metals refining cementation" (Residues 1) must not be classified to possess eye irritant properties or eye corrosion.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
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 irritation/corrosion of "Residues, precious metal refining cementation" was determined by using the “theory of additivity” of Regulation (EC) 1272/2006 section 3.2.3.3. “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 classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The UVCB substance "Residues, precious metal refining cementation" (Residues 1) does not possess a skin irritation/coorosion potential in accordance with Guidance on the application of the CLP criteria Version 4.0 - November 2013 (theory of additivity was applied). Hence, "Residues, precious metal refining cementation" (Residues 1) does not require classification as skin irritant according to 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 irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
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 eye irritation/corrosion of "Residues, precious metal refining cementation" (Residues 1) was determined by using the “theory of additivity” of Regulation (EC) 1272/2006 section 3.2.3.3. “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 classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The UVCB substance "Residues, precious metal refining cementation" (Residues 1) does not possess an eye irritation/corrosion potential in accordance with Guidance on the application of the CLP criteria Version 4.0 - November 2013 (theory of additivity was applied).
Hence, "Residues, precious metal refining cementation" (Residues 1) does not require classification as eye irritant according to 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 irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Substance specific information for the UVCB substance "Residues, precious metals refining cementation" is not available for the endpoint "Irritation/Corrosion". 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 “theory of additivity" (Regulation (EC) No 1272/2008, section 3.2.3.and 3.3.3.with the MeClas tool.

In total two different grades of "Residues, precious metals 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, precious metals refining cementation" two C&L entry (Residues 1 no C&L and Residues 2 Skin corr/irr 1B, Eye dam. 1) for irritation/ corrosion were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

Skin irritation:
The UVCB substance "
Residues, precious metals refining cementation" (Residues 1) does not possess any skin irritation potential in accordance with Regulation (EC) 1272/2008 (theory of additivity was applied) anddoes not require classification as skin irritant according to Regulation (EC) 1272/2008.

Eye irritation:
The UVCB substance "
Residues, precious metals refining cementation"(Residues 1) does not possess an eye irritation potential in accordance with Regulation(EC) 1272/2008 (theory of additivity was applied) and does not require classification as eye irritant according to Regulation (EC) 1272/2008.

Respiratory irritation:

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) and repeated dose toxicity (endpoint 7.5) for further information.