Registration Dossier

Administrative data

Description of key information

No information on animal testing for skin and eye irritation of “Slags,  precious metal refining” 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). Hence, the UVCB substance “Slags, precious metal refining” - composition profile 2 meets classification criteria as Skin Irrit. 2 and has to be labelled with H315 (Causes skin irritation). Furthermore, “Slags, precious metal refining” - composition profile 2 requires classification as Eye Damage 1 in accordance with Regulation (EC) 1272/2008 and requires labelling with H318 (Causes serious eye damage). Since, “Slags, precious metal refining” - composition profile 2 contains ≥ 20 % calcium oxide that is classified as STOT SE Cat. 3 since calcium oxide provokes respiratory irritation, the UVCB substance requires classification as STOT SE 3, as well.

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:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for skin irritation/corrosion of “Slags, precious metal refining” was determined by using the “theory of additivity” of Regulation (EC) 1272/2006 section 3.2.3.3. “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

"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:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to MeClas “Slags, precious metals refining” - composition profile 2 meets classification criteria for Skin Irrit. 2 (theory of additivity was applied) and requires labelling with H315 (causes skin irritation) 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:
adverse effect observed (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:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
The C&L for eye irritation/corrosion of "Slags, precious metal refining" was determined by using the “theory of additivity” of Regulation (EC) 1272/2006 section 3.2.3.3. “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

"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:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The UVCB substance "Slags, precious metal refining" meets classification criteria for eye corrosion (theory of additivity was applied) and requires labelling with H318 (causes severe eye damage) 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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Substance specific information for the UVCB substance "Slags, precious metal refining" is not available for the endpoint "Irritation/Corrosion". 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 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.

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 for skin irritation (i.e., skin irritation Skin Irrit. 2 and skin corrosive Skin Corr. 1B) and one C&L entry (i.e., eye damaging) for eye irritation were generated. Each group is described in a separate endpoint study record and endpoint summary.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Skin irritation:
“Slags, precious metal refining” - composition profile 2 meets classification criteria for skin irritation Skin Irrit. (theory of additivity was applied) and requires labelling with H315 (causes skin irritation) as defined in Regulation (EC) 1272/2008.

Eye irritation:
“Slags, precious metal refining” - composition profile 2 meets classification criteria for Eye Damage 1 (theory of additivity was applied) and requires labelling with H318 (causes severe eye damage) as defined in 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 organs toxicity- single exposure (endpoint IUCLID 7.2) and - repeated exposure (endpoint IUCLID 7.5). However, since “Slags, precious metal refining” - composition profile 2 contains ≥ 20 % calcium oxide that is classified as STOT SE 3, since calcium oxide provokes respiratory irritation, the UVCB substance requires classification as STOT SE 3, as well. In conclusion, “Slags, precious metal refining” - composition profile 2 meets classification criteria as STOT SE 3 and requires labelling with H335 (May cause respiratory irritation).