Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
Administrative data
- 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
Data source
Reference
- Reference Type:
- other: Assessment report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
- 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
Test material
- Reference substance name:
- Unknown
- Cas Number:
- Unknown
- IUPAC Name:
- Unknown
- Reference substance name:
- Calcium oxide
- EC Number:
- 215-138-9
- EC Name:
- Calcium oxide
- Cas Number:
- 1305-78-8
- Molecular formula:
- CaO
- IUPAC Name:
- oxocalcium
- Reference substance name:
- Quartz (SiO2)
- EC Number:
- 238-878-4
- EC Name:
- Quartz (SiO2)
- Cas Number:
- 14808-60-7
- Molecular formula:
- SiO2
- IUPAC Name:
- Quartz
- Reference substance name:
- Zinc sulphide
- EC Number:
- 215-251-3
- EC Name:
- Zinc sulphide
- Cas Number:
- 1314-98-3
- Molecular formula:
- SZn
- IUPAC Name:
- thioxozinc
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- Silicon dioxide
- Reference substance name:
- Carbon
- EC Number:
- 231-153-3
- EC Name:
- Carbon
- Cas Number:
- 7440-44-0
- Molecular formula:
- C
- IUPAC Name:
- Carbon
- Test material form:
- solid: nanoform
- Remarks:
- Fine black powder
- Details on test material:
- - State of aggregation:
spherical particles clustered together to form loose aggregates in organic media.
- Particle size distribution:
median (d(50)) size of 27.51 nm at the major axis and 23.62 nm at the minor axis.
- Shape of particles:
Spheroid
- Surface area of particles:
136.368 m2 cm-3
- Coating:
none
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Results and discussion
- Remarks on result:
- other: At present, based on the available information, the substance does not meet the mutagenicity classification criteria of the CLP regulation
Applicant's summary and conclusion
- 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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