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Description of key information

No information on animal testing of “Matte leaching residue" is available. However, “Matte leaching residue" contains constituents ≥ 0.1 % that are classified as a Carc. 1A carcinogen (As2O3, NiSO4). Hence, “Matte leaching residue" meets classification criteria for carcinogenicity and requires classification as “Carc. 1A”, H350 (May cause cancer).

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity, other
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:
Carcinogenicity 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 Carcinogen Cat. 1A - H350.

Conclusions:
The study provides a conservative estimate of carcinogenicity. The analysed UVCB sample is classified as Carcinogen Cat. 1A - H350.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Carcinogenicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
carcinogenicity, other
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:
Carcinogenicity 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 Carcinogen Cat. 1A - H350.

Conclusions:
The study provides a conservative estimate of carcinogenicity. The analysed UVCB sample is classified as Carcinogen Cat. 1A - H350.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Carcinogenicity: via dermal route

Link to relevant study records
Reference
Endpoint:
carcinogenicity, other
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:
Carcinogenicity 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 Carcinogen Cat. 1A - H350.

Conclusions:
The study provides a conservative estimate of carcinogenicity. The analysed UVCB sample is classified as Carcinogen Cat. 1A - H350.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

Carcinogenicity classification of UVCB substances is based on the presence of a constituent ≥ 0.1 % classified for carcinogenicity Carc. 1A or Carc. 1B and on the presence of a constituent ≥ 1 % classified for carcinogenicity Carc. 2, respectively.

Matte leaching residue" contains constituents ≥ 0.1 % classified for carcinogenicity Carc. 1A (NiSO4 (inhalation route); As2O3 (oral route)) and constituents ≥ 1 % classified for carcinogenicity Carc. 2 (i.e., lead and lead compounds). Hence, “ Matte leaching residue" is considered to induce cancer and must be classified as carcinogenic Carc. 1A (H350), in accordance with Regulation (EC) 1272/2008.

Additional information

Substance specific information for the UVCB substance Matte leaching residue" is not available for the endpoint "Carcinogenicity". 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 the mixture classified as carcinogen that trigger classification of the mixture” and respective rules of Regulation (EC) 1272/2006 section 3.6.3.1 “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 grades of 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., carcinogen Cat. 1A) for carcinogenicity was generated, since all composition profiles contains arsenic trioxide and nickel sulfate ≥ 0.1% relevant for C&L as Carc. Cat. 1A.


Justification for selection of carcinogenicity via oral route endpoint:
i.e., As2O3

Justification for selection of carcinogenicity via inhalation route endpoint:
i.e., NiSO4

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