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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 424-970-3 | 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:
- 4 October - 18 October 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 29 December 1992
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 424-970-3
- EC Name:
- -
- Cas Number:
- 166255-23-8
- Molecular formula:
- C16-H14-O3.C6-H16-O3-Si
- IUPAC Name:
- Triethoxysilylpropyl Dibenzoyl Resorcinol
- Test material form:
- solid
- Details on test material:
- Appearance: light yellow solid lumps (2-3 cm)
Constituent 1
- Specific details on test material used for the study:
- Storage conditions: room temperature
Method
- Target gene:
- Histindine and tryptophan
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9-homogenate
- Test concentrations with justification for top dose:
- First assay: 0, 62, 185, 556, 1667 and 5000 µg/ plate.
Second assay: 0, 156, 313, 625, 1250 and 2500 µg/ plate. - Vehicle / solvent:
- Solvent: DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- The Salmonella typhimurium strains were provided by Dr. B.N. Ames (University of California Berkeley, USA).
Two mutagenicity assays were performed. The plate-incorporation method with the histidine-requiring S. typhimurium mutants TA 1535, TA 1537, TA 98 and TZ 100 and the tryptophan-requiring Escherichia coli mutant WP2 uvrA as indicator strain was applied.
To 2 mL molten top agar containing 0.6% agar, 0.5% NaCl and 0.05 mM L-histidine,HCl/0.05 mM biotin, maintained at 46ºC were added subsequently: 0.1 mL of a fully grown culture of the appropriate strain, 0.1 mL of the appropriate test substance solution or of the negative or positive control substance, and 0.5 mL S9-mix for metabolic activation or 0.5 mL sodium phosphate 100 mM (pH 7.4) for without metabolic activation. The ingredients were thoroughly mixed and the mix was immediately poured onto minimal glucose agar plates (1.5% agar in Vogel and Bonner medium E with 2% glucose). All determinations were made in triplicate. The plates were incubated at ca. 37ºC for three days. Subsequently, the his+ revertants were observed. Cytotoxicity was defined as a reduction in the number of revertant colonies and/or a clearing of the background lawn of bacterial growth. - Rationale for test conditions:
- A preliminary test to assess the toxicity of the test substance to the bacteria was not performed, as no cytotoxicity was expected. Instead, the toxicity test was incorporated into the first mutagenicity assay.
- Evaluation criteria:
- A response is considered to be positive if the mean number of revertant colonies on the test plate was increased two-fold or more compared to that on the vehicle control.
A test substance is considered to be mutagenic if a concentration-related increase or if a positive response reproducible in two independent assays is observed.
A test substance is considered to be not mutagenic in the bacterial gene mutation test if it produces neither a dose-related increase in the mean number if revertant colonies nor a reproducible positive response at any of the test points.
Historical data on the bacterial reverse mutation test (including positive and negative controls) are included in the report. - Statistics:
- Not performed.
Results and discussion
Test resultsopen allclose all
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Detailed results are attached below.
After addition of the test substance to the plates a white precipitation was observed, especially at the highest concentrations.
SDBR was slightly toxic to the TA 1535 and TA 98 strains in the absence of S9 at the highest concentration tested (5000 µg/plate) as evidenced by a decrease in the mean number of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- The results of an Ames study performed according to EC guidelines (with and without metabolic activation) did not indicate mutagenic properties of SDBR.
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.