Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-417-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-09-02 to 2019-10-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 1997-07-21
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP certificate signed 2017-10-06
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Chromium tin calcium silicon sphene
- EC Number:
- 701-417-7
- Cas Number:
- 68187-12-2
- Molecular formula:
- Ca(x)Cr(y)Sn(1-y)SiO5 0,7≤x≤1,0 0
- IUPAC Name:
- Chromium tin calcium silicon sphene
- Test material form:
- solid: particulate/powder
- Details on test material:
- - OLD EC Name: Chrome tin pink sphene
- C.I. name: PIGMENT RED 233
- NEW EC Name: Chromium tin calcium silicon sphene
- Substance type: inorganic pigment
- Physical state: solid, odourless powder with a pink colour
- Stability under test conditions: Stable under normal conditions.
- Storage condition of test material: Keep the container tightly closed. Keep container in an adequately ventilated storage.
Constituent 1
Method
- Target gene:
- hisD (TA 98), hisG (TA 100, TA 1535), hisC (TA 1537), and trpE (WP2 uvr A pKM101)
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: Post-mitochondrial fraction from livers of rodents treated with Aroclor. Supplied by Moltox (Trinova Biochem, Germany).
- quality controls of S9: metabolic capability, sterility, and enzymatic activity - Test concentrations with justification for top dose:
- - 0.02, 0.06, 0.19, 0.56, and 1.67 mg/plate
- The top concentration was based on the solubility profile of the test item. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: two experiments (plate incorporation and preincubation)
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Bacteria were growing in the late exponential or early stationary phase of growth.
- Test substance added in agar (plate incorporation; first experiment) and preincubation (second experiment)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 minutes
- Exposure duration/duration of treatment: 48 hours
- Harvest time after the end of treatment (sampling/recovery times): Colonies were counted immediately after the 48-hour exposure period.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: Cytotoxicity evaluation of the test item was based on the decrease in the number of revertant colonies, or a clearing or diminution of the background lawn.
METHODS FOR MEASUREMENTS OF GENOTOXICIY
- Methods: The number of revertant colonies per plate was counted and recorded by an automatic colony counter. - Rationale for test conditions:
- - The test item was soluble in DMSO at a concentration of 16.7 mg/mL, with no precipitation signs being observed in the assay final mixture with PBS. Nevertheless, precipitation signs were observed in the assay final mixture with PBS at concentrations of 16.7 mg/mL. Therefore, the concentration selected for the cytotoxicity assay was 16.7 mg/mL (1.67 mg/plate).
- No test item related cytotoxic activity was observed in the bacterial system (TA 100) over the concentration range tested between 0.02-1.67 mg/plate. - Evaluation criteria:
- - The criteria used for determining a positive result take into account a dose-response effect in the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system.
- A result is considered positive whenever the number of revertants of the test item-treated plates is increased when compared to the solvent-treated plates according to the following criteria: Species Strain Mutagenic Ratio (R) cut-off point: Fold increase in revertant colony number above vehicle control: 2-fold (TA 98, TA 100, and WP2 uvr A pKM101), and 3-fold (TA 1535 and TA 1537) - Statistics:
- Not mandatory for this assay.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- BACTERIAL REVERSE MUTATION ASSAY
- No test item related cytotoxic activity was observed at any of the concentrations tested.
- Precipitation signs were observed in the assay final mixture with PBS at concentrations of 16.7 mg/mL. Therefore, the top concentration selected for the main experiment was 16.7 mg/mL (1.67 mg/plate).
- None of the concentrations assayed for the test item showed an increase in the R value (number of revertant colonies in treatment vs. vehicle control) either with or without S9 metabolic activation regardless of the procedure.
- No dose response exceeding the threshold for the test item was observed in any of the tested bacterial strains.
- The revertant colonies in the vehicle control cultures were well within the historical control data range demonstrating the validity of the assay.
- The positive control mutagens induced distinct increases in the revertant colony number above the threshold values demonstrating the sensitivity of the assay and the metabolic activity of the S9 mix.
Applicant's summary and conclusion
- Conclusions:
- The test item Chromium tin calcium silicon sphene (Pigment Red 233) does not induce point mutations or frameshifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure over the concentration range tested.
Therefore, the test item Chromium tin calcium silicon sphene (Pigment Red 233) is considered to be non-mutagenic under the experimental conditions assayed.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.