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EC number: 456-880-5 | CAS number: 439685-79-7
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 November - 16 December 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD Guideline 471 with minor deviations: no data on number of cells per culture
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no data on number of cells per culture
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material: Mexoryl SBF
- Physical state: Thick brownish paste (very sticky)
- Analytical purity: 92 %
- Lot/batch No.: 003D001
- Date of receipt: 18 November 2005
- Expiration date of the lot/batch: October 2006
- Storage condition of test material: Stored at +4 °C and protected from light
Constituent 1
Method
- Target gene:
- His+ for S. typhimurium
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: see table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % (v/v) S9 mix; S9 fraction prepared from liver homogenates of rats induced with Aroclor 1254 (500 mg/kg bw) by intraperitoneal route
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 10, 100, 500, 1000, 2500 and 5000 µg/plate, with and without S9 mix in TA 98, TA 100 and TA 102 strains (direct plate incorporation method)
Mutagenicity tests:
- Experiment 1: 312.5, 625, 1250, 2500 and 5000 μg/plate, with and without S9 mix in all 5 strains (direct plate incorporation method)
- Experiment 2: 312.5, 625, 1250, 2500 and 5000 μg/plate, with S9 mix (preincubation method) and without S9 mix (direct plate incorporation method) in all 5 strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water for injections
- Batch No.: GVD21A
- Source: Fresenius-Kabi, Sèvres, France
Formulation procedure:
- Prior to use, the test item was maintained at room temperature for 2-3 h, before manipulation.
- Test item was dissolved in the vehicle at a concentration of 50 mg/mL for the preliminary toxicity test and both mutagenicity experiments. The preparations were made immediately before use.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injections
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (1 µg/plate in TA 100 and TA 1535); 9-aminoacridine (50 µg/plate in TA 1537); 2-nitrofluorene (0.5 µg/plate in TA 98); mitomycin C (0.5 µg/plate in TA 102)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injections
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine (2 µg/plate in TA 100, TA 1535, TA 1537 and TA 98); 2-Anthramine (10 µg/plate in TA 102)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: All five strains of Salmonella typhimurium were supplied by B.N. Ames' Laboratory (University of California, Berkeley, USA).
METHOD OF APPLICATION: In agar (direct plate incorporation and preincubation method)
DURATION
- Preincubation period: 60 minutes at 37 °C
- Incubation period: 48-72 h at 37 °C for both direct plate incorporation and preincubation methods
NUMBER OF REPLICATIONS:
- Preliminary experiment: 1 plate/dose
- Mutagenicity experiments: 3 plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: Evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
OTHER: After 48 to 72 h of incubation at 37 °C, revertants were scored with an automatic counter (Cardinal counter, Perceptive Instruments, Suffolk, UK). - Evaluation criteria:
- - A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result.
- Reference to historical data along with biological relevance was considered during the evaluation. - Statistics:
- None
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Test substance was freely soluble in the vehicle at 50 mg/L and non toxic at the doses used (10, 100, 500, 1000, 2500 and 5000 µg/plate).
MUTAGENICITY TESTS:
- No precipitate was observed in the petri plates when scoring the revertants at any dose-level.
- No toxicity was noted towards all the strains used, both with and without S9 mix.
- Test item did not induce any noteworthy increase in the number of revertants, both with and without S9 mix, in any of the five strains.
OTHERS:
- Sterility of the S9 mix was checked before the beginning and at the end of each experiment and was found to be satisfactory. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See file attached
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, Mexoryl SBF is not considered as mutagenic in S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102). - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were exposed to Mexoryl SBF at the following concentrations:
Preliminary toxicity test: 10, 100, 500, 1000, 2500 and 5000 µg/plate, with and without S9 mix in TA 98, TA 100 and TA 102 strains (direct plate incorporation method).
Mutagenicity tests:
- Experiment 1: 312.5, 625, 1250, 2500 and 5000 μg/plate, with and without S9 mix in all 5 strains (direct plate incorporation method).
- Experiment 2: 312.5, 625, 1250, 2500 and 5000 μg/plate, with S9 mix (preincubation method) and without S9 mix (direct plate incorporation method) in all 5 strains.
Metabolic activation system used in this test was10 % (v/v) S9 mix. S9 fraction was prepared from liver homogenates of rats induced with Aroclor 1254 (500 mg/kg bw) by intraperitoneal route. Vehicle control and positive control groups were also included in mutagenicity tests.
The test substance did not induce precipitation or toxicity at any of the doses used either in the preliminary toxicity test or mutagenicity tests. The positive and vehicle controls induced the appropriate responses in the corresponding strains. Mexoryl SBF showed no substantial increases in revertant colony numbers over control count obtained with any of the tested strains at any concentrations in either presence or absence of S9 mix
Under the test conditions, Mexoryl SBF is not considered as mutagenic in this bacterial system.
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