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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

predicted 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:

Genetic toxicity 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

Type of assay:

other: prediction from hazard class

Remarks on result:

not measured/tested

According to MeClas the substance is classified as Mutagenic Cat.2 - H341.

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified as Mutagenic Cat.2 - H341.

Executive summary:

The study provided a conservative estimate, 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.

Reference 2

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

predicted from hazard class

Type of information:

calculation (if not (Q)SAR)

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:

Mutagenic toxicity 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

Type of assay:

other: prediction from hazard class

Remarks on result:

not measured/tested

According to MeClas the substance is classified Mutagenic Cat. 2 - H341.

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for as mutagenic Cat.2 - H341.

Executive summary:

The study provided a conservative estimate, 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.

Reference 3

Endpoint:

in vitro cytogenicity / micronucleus study

Remarks:

predicted from hazard class

Type of information:

calculation (if not (Q)SAR)

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:

Mutagenic toxicity 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

Type of assay:

other: prediction from hazard class

Remarks on result:

not measured/tested

According to MeClas the substance is classified Mutagenic Cat. 2 - H341.

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified for as mutagenic Cat.2 - H341.

Executive summary:

The study provided a conservative estimate, 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.

Genetic toxicity in vivo

Link to relevant study records

Reference

Reference 1

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

calculation (if not (Q)SAR)

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:

Genetic toxicity 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

Type of assay:

other: prediction from hazard class

Sex:

not specified

Genotoxicity:

not specified

Toxicity:

not specified

According to MeClas the substance is classified as Mutagenic Cat.2 - H341.

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified as Mutagenic Cat.2 - H341.

Executive summary:

The study provided a conservative estimate, 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.

Reference 2

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

calculation (if not (Q)SAR)

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:

Genetic toxicity 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

Type of assay:

other: prediction from hazard class

Sex:

not specified

Genotoxicity:

not specified

Toxicity:

not specified

According to MeClas the substance is classified as Mutagenic Cat.2 - H341.

Conclusions:

Good quality study with result derived on basis of the Classification outcome (Mixture toxicity rules) from the reasinable worst case sample of the substance (maximum of typicals across industry as defined in IUCLID section 1.2/4.23). The analysed UVCB sample is classified as Mutagenic Cat.2 - H341.

Executive summary:

The study provided a conservative estimate, 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.

Additional information

Substance specific information for the UVCB substance " Matte leaching residue" is not available for the endpoint "Genetic 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 “generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture.” and respective rules of Regulation (EC) 1272/2006 section 3.5.3.1. “Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture” with the MeClas tool.

In total three different “ Matte leaching residue” were identified by the consortium that could be grouped according to their calculated C&L resulting from the individual composition. However, for “ Matte leaching residue" only one C&L entry (i.e., mutagen Muta. 2) for genetic toxicity was generated, since all composition profiles contains nickel sulfate ≥ 1% relevant for C&L as Muta. 2.

Justification for selection of genetic toxicity endpoint
i.e., nickel sulfate

Short description of key information:
No information on animal testing of “ Matte leaching residue” is available. “ Matte leaching residue” contains one constituent ≥ 1 % (w/w) classified as mutagen Muta. 2 (NiSO4), but no constituent ≥ 0.1 % (w/w) classified as mutagen Muta. 1A/B. In conclusion, “ Matte leaching residue” requires classification as Muta. 2 (H341) in accordance with Regulation (EC) 1272/2008.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

“ Matte leaching residue” contains one constituent ≥ 1 % (w/w) classified as mutagen Muta. 2 (NiSO4), but no constituent ≥ 0.1 % (w/w) classified as mutagen Muta. 1A/B. In conclusion,“ Matte leaching residue” requires classification as Muta. 2 (H341) in accordance with Regulation (EC) 1272/2008.