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Description of key information

No information on animal testing for skin and eye irritation of "Lead bullion, Platinum Group metals rich" 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, "Lead bullion, Platinum Group metals rich" does not contain any constituent ≥ 1 % (w/w) (in sum) classified as Skin Corr. 1A, 1B and 1C and/or ≥ 10 % (w/w) (in sum) classified as Skin Irrit. 2, the UVCB substance "Lead bullion, Platinum Group metals rich" does not require classification as eye irritating or corrosive substance.
Furthermore, since, "Lead bullion, Platinum Group metals rich" 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 "Lead bullion, Platinum Group metals rich" does not meet classification criteria for eye irritation/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 "Lead bullion, Platinum Group metals rich" was determined by using the “theory of additivity” of Regulation (EC) 1272/2006 section 3.2.3.3.2 “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

Lead bullion, Platinum Group metals rich refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Lead bullion, Platinum Group metals rich 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 Lead bullion, Platinum Group metals rich 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 classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The UVCB substance "Lead bullion, Platinum Group metals rich" does not possess a skin irritation potential (theory of additivity was applied) and does not meet classification criteria as skin irritating substance according to Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Lead bullion, Platinum Group metals rich", 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 "Lead bullion, Platinum Group metals rich" was determined by using the “theory of additivity” of Regulation (EC) 1272/2006 section 3.2.3.3.2 “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

Lead bullion, Platinum Group metals rich refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Lead bullion, Platinum Group metals rich 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 Lead bullion, Platinum Group metals rich 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 classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The UVCB substance "Lead bullion, Platinum Group metals rich" does not possess an eye irritation potential (theory of additivity was applied) and does not meet classification criteria as eye irritating substance according to Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Lead bullion, Platinum Group metals rich", 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 of "Lead bullion, Platinum Group metals rich" is not available for the endpoint "Irritation/Corrosion". In order to meet the requirements for Annex VII - Annex X of Regulation (EC) 1907/2006, read across information from any constituent 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 using the “theory of additivity" (Regulation (EC) No 1272/2008, section 3.2.3. and 3.3.3) with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.

For "Lead bullion, Platinum Group metals rich" one C&L entry (i.e., no C&L) for irritation/corrosion was calculated, since either the individual constituents are not classified for irritation/corrosion or the sum of individual constituents that are classified for irritation/corrosion are not above the cut-off values given in Regulation (EC) 1272/2008.

Justification for classification or non-classification

Skin irritation:
The UVCB substance "
Lead bullion, Platinum Group metals rich" does not possess a skin irritation potential (theory of additivity was applied) and does not meet classification criteria as skin irritating substance according to Regulation (EC) 1272/2008.

Eye irritation:
The UVCB substance "
Lead bullion, Platinum Group metals rich" does not possess an eye irritation potential (theory of additivity was applied) and does not meet classification criteria as eye irritating substance according to Regulation (EC) 1272/2008.

Respiratory irritation:

The generic term respiratory tract irritation (RTI) covers two different effects: (i) sensory irritation and (ii) local cytotoxic effects. The classification is usually covered under the endpoint specific target organ toxicity- single exposure (endpoint IUCLID 7.2) and - repeated exposure (endpoint IUCLID 7.5). Please refer to the endpoint summaries on acute toxicity and repeated dose toxicity for further information.

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