[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The available information on the constituents and the presence of unknown constituents in the substance demonstrates that the mutagenicity/genotoxicity endpoint for the registered substance is inconclusive. Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary mechanisms. At present, based on the available information, the substance  does not meet the mutagenicity classification criteria of the CLP regulation (See attachment for full assessment).

 

Link to relevant study records

Reference

Endpoint:

genetic toxicity in vitro, other

Remarks:

An assessment based on all available information available for the constituents.

Type of information:

other: Assessment

Adequacy of study:

weight of evidence

Study period:

2022

Reliability:

other: Assessment based on available information

Rationale for reliability incl. deficiencies:

other: Assessment based on available information

Principles of method if other than guideline:

An assessment was performed based on the information available for the constituents (see thee attachment for the details)

Type of assay:

other: All data available in the literature for constituents were taken into consideration

Remarks on result:

other: At present, based on the available information, the substance  does not meet the mutagenicity classification criteria of the CLP regulation

Conclusions:

The available information on the constituents and the presence of unknown constituents in the substance demonstrates that the mutagenicity/genotoxicity endpoint for the registered substance is inconclusive. Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary mechanisms. At present, based on the available information, the substance  does not meet the mutagenicity classification criteria of the CLP regulation (See attachment for full assessment).

Executive summary:

An assessment was performed based on the available information on the constituents present in the registered substance.

 

Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary mechanisms. Another constituent ZnS cannot be evaluated directly as the database for mutagenicity is limited for this constituent. Other similar Zn salts showed conflicting results in various mutagenicity assays both in vitro and in vivo. Another known constituent CaO was shown to be negative in various mutagenicity/genotoxicity assay.

 

Overall, the available information on the constituents and the presence of unknown constituents in the substance demonstrates that the mutagenicity/genotoxicity endpoint for the registered substance is inconclusive. Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary mechanisms. At present, based on the available information, the substance  does not meet the mutagenicity classification criteria of the CLP regulation (See attachment for full assessment).

 

Endpoint conclusion

Endpoint conclusion:

no study available (further information necessary)

Mode of Action Analysis / Human Relevance Framework

Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary or indirect mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary / indirect mechanisms.

Justification for classification or non-classification

An assessment was performed based on the available information on the constituents present in the registered substance.

 

Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary mechanisms. Another constituent ZnS cannot be evaluated directly as the database for mutagenicity is limited for this constituent. Other similar Zn salts showed conflicting results in various mutagenicity assays both in vitro and in vivo. Another known constituent CaO was shown to be negative in various mutagenicity/genotoxicity assay.

 

Overall, the available information on the constituents and the presence of unknown constituents in the substance demonstrates that the mutagenicity/genotoxicity endpoint for the registered substance is inconclusive. Carbon black and silica, which are the major constituents of the registered substance, appear to be genotoxic through secondary mechanisms of toxicity; however, these two constituents cannot be concluded to be mutagenic due to the availability of conflicting data. The in vitro tests might not be able to detect mutagenicity through secondary mechanisms. At present, based on the available information, the substance  does not meet the mutagenicity classification criteria of the CLP regulation (See attachment for full assessment).