Lead bullion, Platinum Group Metals rich

Endpoint summary

Description of key information

No information on animal testing of "Lead bullion, Platinum Group metals rich" on acute toxicity is available. The C&L was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. Applying these rules the converted acute toxicity point estimate value for acute toxicity, oral route is 500 mg/kg bw in accordance with EU CLP Guidance Annex I Table 3.1.2. No C&L for acute inhalation toxicity and toxicity via skin is required.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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 acute oral toxicity of "Lead bullion, Platinum Group metals rich" was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Dose descriptor:

other: Acute Toxicity Estimate (ATE)

Effect level:

> 300 - <= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: calculation

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:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to MeClas, "Lead bullion, Platinum Group metals rich" should be classified as Acute Tox. 4 and labelled with H302 (harmful if swallowed) as defined in Regulation (EC) 1272/2008.

The converted acute toxicity point estimate value for acute toxicity, oral route in accordance with EU CLP Guidance Annex I Table 3.1.2 is 500 mg/kg bw. It is noted that this value is designed to be used in the calculation of the ATE for classification on a mixture based on its components and do not represend test results.

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:

adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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 acute inhalation toxicity of "Lead bullion, Platinum Group metals rich" was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Dose descriptor:

other: Acute Toxicity Estimate (ATE)

Effect level:

> 5 mg/L air

Based on:

test mat.

Remarks on result:

other: calculation

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:

According to MeClas, "Lead bullion, Platinum Group metals rich" should not be classified as acute toxic via inhalation as defined in Regulation (EC) 1272/2008.

The converted acute toxicity point estimate value for acute toxicity, inhalation route in accordance with EU CLP Guidance Annex I Table 3.1.2 is 1.5 mg/L. It is noted that this value is designed to be used in the calculation of the ATE for classification on a mixture based on its components and do not represend test results.

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

Dose descriptor:

discriminating conc.

Value:

5 000 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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 acute dermal toxicity of "Lead bullion, Platinum Group metals rich" was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. For detailed information for classification strategy of UVCBs please refer to IUCLID section 13 (attachment “PMC Classification method”).

GLP compliance:

no

Dose descriptor:

other: Acute Toxicity Estimate (ATE)

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: calculation

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:

According to MeClas, "Lead bullion, Platinum Group metals rich" does not meet the classification criteria for acute toxicity via exposure to skin as defined in 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

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Substance specific information for the UVCB substance "Lead bullion, Platinum Group metals rich" as such is not available for the endpoint "Acute Toxicity". 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 “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture” with the aid of 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., harmful if swallowed) for acute toxicity were calculated.

Justification for classification or non-classification

The available information indicates that "Lead bullion, Platinum Group metals rich" is harmful via ingestion, but not acutely toxic or harmful via the dermal and inhalation route. Lead bullion, Platinum Group metals rich requires classification as harmful if swallowed (Acute Tox. 4) according to Regulation (EC) 1272/2008. Classification of "Lead bullion, Platinum Group metals rich" for acute toxicity via the dermal and inhalation route is not required according to Regulation (EC) 1272/2008.

Specific target organ toxicant (STOT) - single exposure: oral, inhalation and dermal
The classification criteria according to Regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure are not met since no adverse health effects, including reversible and irreversible, were observed immediately or delayed after exposure.