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EC number: 700-641-2 | CAS number: 1261240-30-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- EC Number:
- 700-641-2
- Cas Number:
- 1261240-30-5
- Molecular formula:
- C37H46O5
- IUPAC Name:
- 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- Test material form:
- other: Crystalline powder
- Details on test material:
- CAS No.: 1261240-30-5
Major ingredients: 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
Lot/Batch No.: s25211001
Purity of active ingredient: 99-100 %
Physical description: White crystalline powder, non-sterile and odourless
Solvent and solubility: (g in 100 ml solvent at 25 degree C)
Toluene: 25
Acetone:35
Dicholomethane: > 50
Water: < 0.2
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- The test substance was exposed to the S9 mixture consisted of S9 fraction (Aroclor 1254-induced) and cofactor which was used to mimic the metabolic activation system. The S9 mixture was added at final concentration of 0.94% (v/v).
- Test concentrations with justification for top dose:
- 5; 2.5; 1.25; 0.625; 0.313 mg/plate
- Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- yes
- Remarks:
- Sterile water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- The positive control reference substances were selected on the basis of the type of bacterial strains used.
- Positive control substance:
- other: In the absence of S9: 2-nitrofluorene (2-NF), 1 µg/plate (TA 98); Sodium azide (SA), 1 µg/plate (TA 100); Mitomycin C (MMC), 0.2 µg/plate (TA 102); SA, 1 µg/plate (TA 1535); 9-aminoacridine (9-AA), 50 µg/plate (TA 1537).
- Remarks:
- Postive control substance: in the presence of S9: 2-aminoanthracene (2-AA), 1 µg/plate (TA 98); Benzo[a]pyrene (BP), 1 µg/plate (TA 100); 2-AA, 5 µg/plate (TA 102); 2-AA, 5 µg/plate (TA 1535); 2-AA, 5 µg/plate (TA 1537).
- Evaluation criteria:
- (1) The raw data of revertant colony values were represented with Mean+/- S.D.
(2) Cell toxicity determination
A cytotoxic effect was concluded when a decrease in revertant colonies over the negative/vehicle control was lower than 0.5-fold, loss of bacterial lawn, or pin colony appeared. Plates would be labeled and excluded from statistics while cytotoxic efect occurred.
(3) An increase in revertants over the negative control would be as the cut-off between a mutagenic and non-mutagenic response:
TA98, TA100 and TA 102: more than two-fold increase in revertants over the negative/vehicle control, then the test substance would be considered as a potential mutagen. TA 1535 and TA 1537: more than three-fold increase in revertants over the negative/vehicle control, then the test substance would be considered as a potential mutagen.
(4) If the test substance was considered as a potential mutagen, the raw data would be further analyzed by ANOVA to evaluate the difference between negative/vehicle control group and test substance groups, and p < 0.05 indicates the significant difference.
(5) If the data showed statistically significant, then to evaluate the dose-related response in the numbers of revertant colonies on the test substance groups as compared with the vehicle control group. Once dose-related response was confirmed, the test substance would be considered as a mutagen.
Strain: TA98, TA100, TA102; Revertants number: two-fold increase over the negative/vehicle control; Dose-dependent response: yes/no; Result: mutagenic/non-mutagenic.
Strain: TA1535, TA1537; Revertants number: trhee-fold increase over the negative/vehicle control; Dose-dependent response: yes/no; Result: mutagenic/non-mutagenic.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
(1) The genotyping of Salmonella typhimurium strains
The genotypes of five Salmonella typhimurium strains (TA98, TA100, TA102, TA1535 and TA1537) for this study swere identified. The result was organized in table 1 and Appendix D-1 of the report attached. HTe historic control data of bacterial reverse mutation test was listed in Appendix C of the report attached.
(2) Result of Dose Rang Finding Test in TA100
Five doses (5,2.5,1.25,0.625 and 0.313 mg/plate) of test substance were used, and no cytotoxic and mutagenic effects occurred. Based on the result, 5 mg/plate of test substance was determined as the highest dose for five strains bacterial reverse mutation test. All the raw data were organized in Table 2 and Appendix D-2 of the report attached.
(3) Result of Bacterial Reverse Mutation Test (5 strains)
Based on the result of dose range finding test, the concentration of 5 mg/plate of test substance was used as the highest dose and remaining four doses 2.5, 1.25, 0.625 and 0.313 mg/plate were used for bacterial reverse mutation test in five Salmonella typhimurium strains. This testing system was validated and authentic. The testing result organized in Table 3 and Appendix D-3 of the report attached. The numbers of revertant colony in negative control groups of each strain were in the range of historic control data. The revertant colonies in positive control group were more than two times (in TA98, TA100, and TA102) and three times (in TA1535 and TA1537) over negative control groups. No significant increase in the nubmers of revertant colonies was observed at all concentrations of testing strains in both presence and absence of S9 metabolic mixture, indicated the test substance did not present genotoxic effect.
Applicant's summary and conclusion
- Conclusions:
- negative with metabolic activation
negative without metabolic activation
According to the numbers of revertant colonies at all the testing conditions of the five strains used in this study (i.e. TA98, TA100, TA102, TA1535 and TA1537), the test substance did not present genotoxic effect at all concentrations of testing strains in the condition of both presence and absence of S9 metabolic mixture. In conclusion, test substance was non-genotoxic in the testing system applied in this study.
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