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EC number: 413-850-6 | CAS number: 123968-25-2 SUMILIZER GS
- 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:
- 08.02.2010 - 20.04.2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate included in the full study report
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate
- EC Number:
- 413-850-6
- EC Name:
- 2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate
- Cas Number:
- 123968-25-2
- Molecular formula:
- C37H56O3
- IUPAC Name:
- 2-{1-[2-hydroxy-3,5-bis(2-methylbutan-2-yl)phenyl]ethyl}-4,6-bis(2-methylbutan-2-yl)phenyl prop-2-enoate
- Reference substance name:
- ZIKANOX-549
- IUPAC Name:
- ZIKANOX-549
- Details on test material:
- Name: ZIKANOX-549
Manufacturer & Supplier: ZIKO Ltd.
Manufactured: 2009-09-05
Date of Receipt: 2009-10-29
Lot No.: 10909001-001
Purity: 99.55 %
Storage Condition: Room Temperature
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: base pair substitution type
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: base pair substitution type
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: base pair substitution type
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: frame shift type
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: frame shift type
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- - Treatment of test item: Treatment of test item was assayed using pre-incubation method. 100 μL of test item, 0.5 mL of S9 mix (or sodium phosphate buffer, pH 7.49) and 0.1 mL of bacterial culture were added to each test tube of dry heat sterilization. This mixture was shaken for 20 minutes using shaking incubator (120 rpm), then was dispensed top agar and was poured onto minimal glucose agar plate (one tube per plate). Vehicle control groups were treated with vehicle only and each of positive control groups was treated with strain-specific positive controls. The solution of the highest concentration of test item (0.1 mL) and S9 mix (0.1 mL), without bacterial culture, were also plated to check sterility. After the top agar was solidified, the plates were inverted, and incubated at 37 °C for about 48 hours. Then the revertants were counted.
- Dose range-finding test: Dose range-finding test was performed with the five test strains at concentration levels of 50, 100, 500, 1000 and 5000 μg/plate both in the absence (S9-) and presence (S9+) mix, and then assayed in triplicate per concentration.
- Main test: 5000 μg/plate both in the absence (S9-) and presence (S9+) of S9 mix was selected as the highest cocentration of the main test considering the result of dose range-finding test. The test item of the highest concentration was serially two-fold diluted to make 5 concentration levels (312.5, 625, 1250, 2500 and 5000 μg/plate), and then assayed in triplicate per concentration - Vehicle / solvent:
- Vehicle (Negative Cotrol):
Name: Dimethyl sulfoxide (DMSO)
CAS No.: 67-68-5
Supplier: Sigma-Aldrich, Inc.
Lot No.: 108K01867
Purity: 99.5 %
Storage Condition: Room Temperature
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 4 different positive controls used in the test
- Positive control substance:
- sodium azide
- Remarks:
- Additional positive controls : 9-aminoacridine (S9-), 2-(2-furyl)-3-(5-nirto-2-furyl)acrylamide (S9-), 2-aminoanthracene (S9+)
Migrated to IUCLID6: S9-
- Details on test system and experimental conditions:
- * Positive control I (S9-) *
Name: Sodium azide (NaN3)
CAS No.: 26628-22-8
Supplier: Wako Pure Chemical Industries, Ltd.
Lot No.: DWL5550
Purity: 98 %
Storage condition: Room temperature
Application: TA1535 (0.5 μg/plate)
* Positive control II (S9-) *
Name: 9-aminoacridine (9-AA)
CAS No.: 90-45-9
Supplier: Sigma-Aldrich, Inc.
Lot No.: 106F06681
Purity: 98 %
Storage Condition: Room temperature
Application: TA1537 (80 μg/plate)
* Positive control III (S9-) *
Name: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
CAS No.: 3688-53-7
Supplier: Wako Pure Chemical Industries, Ltd.
Lot No.: PAN0050
Purity: 98 %
Storage Condition: Room temperature
Application: TA98 (0.1 μg/plate), TA100 (0.01 μg/plate) and E.coli WP2uvrA (0.01 μg/plate)
* Positive control IV (S9+) *
Name: 2-aminoanthracene (2-AA)
CAS No.: 613-13-8
Supplier: Sigma-Aldrich, Inc.
Lot No.: S34773-358
Purity: 96 %
Storage Condition: Room temperature
Application: TA98 (0.5 μg/plate), TA100 (1.0 μg/plate), TA1535 (2.0 μg/plate), TA1537 (2.0 μg/plate) and E.coli WP2uvrA (10 μg/plate) - Evaluation criteria:
- It was judged to be positive if there was a reproducible increase in the number of colonies in a dose-dependant manner, at least in one test strain with or without the metabolic system, clearly exceeding 2 times of that of control.
Results and discussion
Test results
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- - Results were expressed as the mean numbers of colonies ± standard deviation form triplicate plates per dose.
- Growth of bacteria in the used preparation of test item and S9 mix, was not observed in the sterility test.
- There were no inhibition of microbial growth by test item in the form of extracted solution in all test strains. According to these results , 5000 μg/plate was determined as the highest concentration of the main test both in the absence (S9-) and presnece (S9+) of S9 mix.
- The main test was performed in the five test strains at concentration levels of 312.5, 625, 1250, 2500 and 5000 μg/plate both in the absence (S9-) and presence (S9+) of S9 mix. In all test strains, there was no increase in the number of revertant colonies compared to the negative control at any concentration of test item either in the presence or in the absence of metabolic activation system.
- Confirmation test was performed with the same method and concentration levels of the main test both in the absence (S9-) and presence (S9+) of S9 mix.
- The positive controls induced a marked increase in the number of revertant colonies compared to the negative control. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Refer to the attached full report.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Test item, ZIKANOX-549, was evaluated for its potential to induce reverse mutation in four histidine auxotroph strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and one tryptophan auxotroph strain of Escherichia coli (WP2uvrA).
DMSO was selected as vehicle control and the test item (ZIKANOX-549) was precipitated at all concentrations in the absence of S9 mix (S9-) and in the presence od S9 mix (S9+).
Considering the precipitation of test item and the growth inhibition in the dose range-finding test, the five concentrations of test item were selected between 312.5 and 5000 μg/plate (312.5, 625, 1250 and 5000 μg/plate). There was no contamination from the test item and S9 mix used in the main test and the number of viable cell counts of overnight cultures, estimated with optical density, was 1.0 ~ 3.5x10E9 cells/mL as its proper value.
In the main test, there was no significant increase in the number of revertant colonies as anticipated.
Therefore, it is considered that the test item, ZIKANOX-549, showed no evidence of mutagenic potential at the concentration range tested in five tested strains of Salmonella typhimurium, and in Escherichia coli strain WP2uvrA under the condition of this study. - Executive summary:
- The test item, ZIKANOX-549, was evaluated for its potential to induce reverse mutation in the histidine strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and one tryptophan auxotroph strain of Escherichia coli (WP2uvrA).
- The test item was dissolved and diluted with DMSO. Based on the dose range-finding test which was performed at concentrations of 50, 100, 500, 1000 and 5000 μg/plate (the highest concentration), the main test was performed where the final concentrations of test item ranged between 312.5, 625, 1250, 2500 μg/plate and 5000 μg/plate with negative and positive control in the absence and presence of metabolic activation system (S9 mix).
- In this study, there was no significant increase in the number of revertant colonies compared to its vehicle control at any dose in any of the strains. In addition, the antibacterial effects such as decrease in the number of colonies were also not observed in any of the strains. The positive controls induced a marked increase in the number of revertant colonies as anticipated.
- Therefore, these results of the bacterial reverse mutation assay showed that, under the conditions of this study, ZIKANOX-549, was not to induce a reverse bacterial mutation at the concentration tested.
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