Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

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: Automatic calculation with MeCLas tool

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:

Skin sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.

GLP compliance:

no

Remarks:

other quality assurance was applied

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

 According to MeClas the substance is classified as Skin sensitiser Cat 1 - H317.

Conclusions:

The study provides a conservative estimate of the Acute Oral toxicity. The substance is classified as Skin sensitiser Cat 1 - H317.

Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Substance specific information for the UVCB substance“Matte leaching residue"is not available for the endpoint "Sensitisation". 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 generic concentration limits of ingredients of the mixture classified as skin sensitizer that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.4.3.3 “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.

Calculation of C&L for composition profile 1 – 3 of“Matte leaching residue" results only inone C&L entry (i.e., Skin Sens. 1) for “Skin Sensitisation”.

Migrated from Short description of key information:
No information on animal testing of “Matte leaching residue" is available. Since, “Matte leaching residue" contains a constituent ≥ 0.1 % (i.e., cobalt and/or nickel sulfate) that may cause skin sensitisation (Skin Sens. 1); the substance must be classified as being a skin sensitiser “Skin Sens. 1 (H317)”. It is noted that no sub-categorisation was performed.

 

Respiratory sensitisation

Link to relevant study records

Reference

Endpoint:

respiratory sensitisation, other

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: Automatic calculation with MeCLas tool

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:

Respiratory sensitisation potential of the UVCB potential was determined by classifying based on Mixture rules from EU CLP (additivity formula of classified components to derive hazard class). The classification criteria were used to estimate effects.

GLP compliance:

no

Remarks:

other quality assurance was applied

According to MeClas the substance is classified as Respiratory sensitiser Cat.1 - H334.

Conclusions:

The study provides a conservative estimate of the Respiratory Sensitisation. The substance is classified as Respiratory sensitiser Cat.1 - H334.

Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Substance specific information for the UVCB substance“Matte leaching residue"is not available for the endpoint "Sensitisation". 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 generic concentration limits of ingredients of the mixture classified as respiratory sensitiser that trigger classification of the mixture and respective rules of Regulation (EC) 1272/2006 section 3.4.3.3 “Classification of mixtures when data are available for all components or only for some components of the mixture” with the MeClas tool. This approach has been presented and discussed with ECHA in several meetings.

Calculation of C&L for composition profile 1 – 3 of “Matte leaching residue" results only inone C&L entry (i.e., Respir. Sens. 1) for “Respiratory Sensitisation”.

Migrated from Short description of key information:
No information on animal testing of “Matte leaching residue" is available. “Matte leaching residue" contains at least one constituent ≥ 0.1 % (w/w) (i.e., cobalt and/or nickel sulfate) that may cause respiratory sensitisation “Resp.Sens. 1” (H334). Hence, the UVCB meets classification criteria for respiratory sensitisation “Resp.Sens. 1” (without sub-categorising) in accordance with Regulation (EC) 1272/2008.

Justification for classification or non-classification

Skin sensitisation

“Matte leaching residue”possesses a skin sensitisation potential and requires classification as skin sensitiser in accordance with Regulation (EC) 1272/2008 Skins. Sens. 1 (H317: May cause an allergic skin reaction.).

Respiratory sensitisation

Furthermore,“Matte leaching residue” contains at least one constituent ≥ 0.1 % (w/w) (i.e., cobalt and/or nickel sulfate) that may cause respiratory sensitisation Resp. Sens.1 (H334). Hence, the substance meets classification criteria for respiratory sensitisation “Resp.Sens. 1” (without sub-categorising) and requires labelling with H334 (may cause allergy or asthma symptoms or breathing difficulties if inhaled) in accordance with Regulation (EC) 1272/2008.