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Toxicological information

Endpoint summary

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Description of key information

No information on animal testing of "Flue dust, precious metal refining" on acute toxicity is available. The C&L of Flue dust, precious metal refining composition profile 2 (Flue dust 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 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. For information on C&L for Flue dust composition profile 1, please refer to the IUCLID endpoint summary "acute toxicity - Flue dust 1" and "acute toxicity - Flue dust 3".

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:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for acute oral toxicity of "Flue dust, precious metal refining" (Flue dust 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”. 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

Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal 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 Flue dust, precious metal 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, "Flue dust, precious metal refining" (Flue dust 2) should be classified as acute toxic oral route 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 "Flue dust, precious metal refining", 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:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for acute inhalation toxicity of "Flue dust, precious metal refining" (Flue dust 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”. 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

Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal 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 Flue dust, precious metal 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, "Flue dust, precious metal refining" (Flue dust 2) should be classified for acute inhalation toxicity 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 "Flue dust, precious metal refining" (Flue dust 2), 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:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for acute dermal toxicity of Flue dust, precious metal refining 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

Flue dust, precious metal refining is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of Flue dust, precious metal 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 Flue dust, precious metal 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, Flue dust, precious metal refining should not be classified for acute dermal toxicity as defined in Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of Flue dust, precious metal refining, 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 "Flue dust, precious metal refining" 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 Flue dust grades (Flue dust 1 – Flue dust 3) were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. Thus, for "Flue dust, precious metal refining" three C&L entries (i.e., no C&L (Flue dust 1), harmful if swallowed and inhaled (Flue dust 2), and toxic if swallowed (Flue dust 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 Flue dust composition profile 2 is harmful via ingestion and inhalation, but not acute toxic or harmful via the dermal route. Flue dust 2 requires classification as harmful if swallowed (Category 4) and harmful if inhaled (Category 4) according to Regulation (EC) 1272/2008. Classification of Flue dust 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 any adverse health effects, including reversible and irreversible, were not observed immediately or delayed after exposure.