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Description of key information

No information on animal testing of "Material for reclaim, precious metal with or without support" on acute toxicity is available. The C&L of "Material for reclaim, precious metal with or without support" (Reclaim 2) 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, Reclaim 2 meets classification criteria for acute toxicity via ingestion and inhalation but does not require classification as acute toxic after skin contact. 
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. The converted acute toxicity point estimate value for acute toxicity, inhalation route is 1500 mg/m³ in accordance with EU CLP Guidance Annex I Table 3.1.2.

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 "Material for reclaim, precious metal with or without support" 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

"Material for reclaim, precious metal with or without support" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Material for reclaim, precious metal with or without support" 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 "Material for reclaim, precious metal with or without support".

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, "Material for reclaim, precious metal with or without support" (Reclaim 2 and Reclaim 3) should be classified as acute toxic via oral route Category 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 represent test results.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Material for reclaim, precious metal with or without support", 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 "Material for reclaim, precious metal with or without support" 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:
> 1 - <= 5 mg/L air
Based on:
test mat.
Remarks on result:
other: calculation

"Material for reclaim, precious metal with or without support" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Material for reclaim, precious metal with or without support" 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 "Material for reclaim, precious metal with or without support".

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, "Material for reclaim, precious metal with or without support" (Reclaim 2) should be classified as acute toxic Acute Tox. 4 and labelled with H332 (harmful if inhaled) 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 "Material for reclaim, precious metal with or without support", 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 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 "Material for reclaim, precious metal with or without support" 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

"Material for reclaim, precious metal with or without support" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of "Material for reclaim, precious metal with or without support" 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 "Material for reclaim, precious metal with or without support".

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, 2Material for reclaim, precious metal with or without support" 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 "Material for reclaim, precious metal with or without support", 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

Additional information

Substance specific information for the UVCB substance "Materials for reclaim, precious metals with or without support" is not available for the endpoint "Acute Toxicity". 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 “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 MeClas tool.

In total three different grades of "Materials for reclaim, precious metals with or without support" (Reclaim 1 - Reclaim 3) were identified by the consortium. Thus, for "Materials for reclaim, precious metals with or without support" three C&L entries (i.e., no classification (Reclaim 1), harmful if swallowed and inhaled (Reclaim 2) and harmful if swallowed and toxic if inhaled (Reclaim 3), respectively) for acute toxicity were calculated. Each group is described in a separate endpoint study record and endpoint summary.

Justification for classification or non-classification

The available information indicates that "Material for reclaim, precious metal with or without support" (Reclaim 2) is harmful via ingestion and inhalation, but not acute toxic or harmful via the dermal route. Reclaim 2 requires classification as harmful if swallowed (Acute Tox. 4, H302) and harmful if inhaled (Acute Tox. 4, H332) according to Regulation (EC) 1272/2008. Classification of "Material for reclaim, precious metal with or without support" (Reclaim 2) for acute toxicity via the dermal 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.

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