Registration Dossier

Administrative data

Description of key information

No information on animal testing of “Slags, precious metal refining” on acute toxicity is available. The C&L for acute toxicity of “Slags, precious metal refining” - composition profile 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”. Furthermore, for specific target organ toxicity – single exposure the generic concentration limit of 20 % for STOT SE Cat. 3 classification was used. Applying these rules, “Slags, precious metal refining” - composition profile 2 meets classification criteria as specific target organ toxicant via single inhalation exposure but is not acutely toxic via ingestion, inhalation and by skin contact.

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 "Slags, 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

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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, “Slags, precious metal refining” - composition profile 2 does not meet classification criteria for acute toxicity via ingestion and does not required labelling in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of “Slags, 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

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 “Slags, 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:
> 5 mg/L air
Based on:
test mat.
Remarks on result:
other: calculation

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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, “Slags, precious metal refining” - composition profile 2 does not meet classification criteria for acute toxicity via inhalation exposure but requires classification as specific target organ toxicity via single exposure Cat. 3 and will be labelled with H335 - May cause respiratory irritation. The reason for classification is that “Slags, precious metal refining” - composition profile 2 consists of ≥ 20% CaO that is classified as STOT SE Cat. 3. This is the generic concentration limit (GCL) for STOT SE Cat. 3 classification relevant for mixtures in accordance with Regulation (EC) 1272/2008.
Executive summary:

The described MeClas-based-calculation provides a conservative estimate of toxicological effects of "Slags, 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 conc.
Value:
5 000 mg/m³

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 Slags, 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

"Slags, precious metal refining" is a complex metal containing UVCB substance with wide concentration ranges for each constituent. Each individual constituent of " Slags, 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 " Slags, 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, "Slags, precious metal refining" 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 "Slags, 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 "Slags, precious metal refining" 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.

In total, two different grades of " Slags, precious metal refining" (composition profile 1 – composition profile 2) were identified by the consortium that could be grouped according to their calculated C&L resulting from the specific composition profile. Thus, for " Slags, precious metal refining" two C&L entries (i.e., no C&L and “toxic if swallowed and toxic if inhaled”, respectively) for acute toxicity were generated. Each group is described in a separate endpoint study record and endpoint summary

Justification for classification or non-classification

The available information indicate that “Slags, precious metal refining” - composition profile 2 does not require classification as acutely toxic or harmful via ingestion, inhalation and after dermal exposure in accordance with Regulation (EC) 1272/2008.

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

Specific target organ toxicant (STOT) - single exposure: inhalation

“Slags, precious metal refining” - composition profile 2 requires classification as specific target organ toxicity via single exposure Cat. 3 and will be labelled with H335 - May cause respiratory irritation. The reason for classification is that “Slags, precious metal refining” - composition profile 2 consists of ≥ 20% CaO that is classified as STOT SE Cat. 3. This is the generic concentration limit (GCL) for STOT SE Cat. 3 classification relevant for mixtures in accordance with Regulation (EC) 1272/2008.