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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 617-901-5 | CAS number: 866607-35-4
- 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:
- 2007-06-23 to 2007-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Well documented study report, GLP compliant, and according to Japanese Guidelines for Screening Mutagenicity Testing Of Chemicals. No deviations from the study protocol were recorded.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [(2R,3R,4R,5S,6S)-3,4,5-tris(acetyloxy)-6-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)oxan-2-yl]methyl acetate
- EC Number:
- 617-901-5
- Cas Number:
- 866607-35-4
- Molecular formula:
- C32H33FO9S
- IUPAC Name:
- [(2R,3R,4R,5S,6S)-3,4,5-tris(acetyloxy)-6-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)oxan-2-yl]methyl acetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: solid
- Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: M0331013A, Tanabe Seiyaku co., Ltd.
- Expiration date of the lot/batch: Not specified
- Purity test date: Not specified
- Purity: 100%
- Appearance at ordinary temperature: white crytalline powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: stable at room temperature under light-shielded consitions
- Solubility and stability of the test substance in the solvent/vehicle: DMSO, 50 mg/mL
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not specified
Method
- Target gene:
- histidine locus (histidine-dependent S. typhimurium strains); tryptophan locus (tryptophan-dependent E.coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/5,6-benzoflavone induced rat liver (S9) from male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- Dose-finding assay: 0, 1.2, 4.9, 20, 78, 313, 1250, 5000 µg/plate
Main assay: 0, 20, 39, 78, 156, 313 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:The solvent was selected based on the following reasons. As the information from sponsor, the test chemical was reported to be hydrolyzed by water, and its solubility in DMSO was found to be 50 mg/mL or more. The preliminary test on solvent selection in the testing facility indicated that the test chemical was dissolved at 5% in DMSO and there were no form or heat production during the dissolution.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2AA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With S9-mix, all strains, 0.5 µg/plate (TA98), 1.0 µg/plate (TA100), 2.0 µg/plate (TA1535, TA1537), 10.0 µg/plate (WP2 uvrA)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- AF-2
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- Without S9-mix, 0.01 µg/plate (TA100, WP2 uvrA), 0.1 µg/plate (TA98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- NaN3
- Positive control substance:
- sodium azide
- Remarks:
- Without S9-mix, 0.5 µg/plate (TA1535)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- ICR-191
- Positive control substance:
- other: 6-Chloro-9-[3-(2-chloroethylamino)-propylamino]-2-methoxyacridine dihydrochloride
- Remarks:
- Without S9-mix, 1.0 µg/plate (TA1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation method
DURATION
- Preincubation period: 20 minutes (with shaking) - After preincubation, a 2.0 mL of top agar was added to the mixture and the resultant mixture was overlaid onto a minimum glucose agar plate. Agar soluion supplemented with 0.5 mM L-histidine and 0.5 mM D-biotin (S. typhimurium) or with 0.5 mM L-tryptophan (E. coli) at a volume ratio of 10:1 was used as a top agar.
- Exposure duration: 48h incubation - After incubation, the growth inhibition of the tester bacterial strain was examined with a stereoscopic microscope, and the revertant colonies were counted.
SELECTION AGENT (mutation assays): histidine (S. typhimurium); tryptophan (E. coli)
NUMBER OF REPLICATIONS: duplicate at each dose level; triplicate for negative control
NUMBER OF CELLS EVALUATED: Revertant colonies within a circle with about 80 mm diameter on a plate with 86 mm diameter were counted with an automatic colony counted (and corrected based on the uncounted area by using a personal computer). When the number of revertant colonies on a plate was 1500 or more, the accuracy of the automatic colony counter was lowered and the colonies were counted manually at 5 different places on a plate with a stereoscopic microscope and the average number of colonies was applied to the area-based correction.
DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition (dose-related)
OTHER:
- For all plates, the growth inhibition of bacterial strain was observed with a stereoscopic microscope (40-fold magnification) and the precipitation was observed by unaided eyes. - Evaluation criteria:
- When the number of revertant colonies on test chemical treatment plates is remarkably increased compared to the spontaneous level (i.e. twice or more of the solvent control value), with a dose-dependency and reproducibility, it is judged to be positive for mutagenicity. Otherwise, it is judged as negative.
- Statistics:
- No statistical analysis is performed for data analysis.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: no information on solubility in water of the test substance. As the information from the sponsor, the test chemical was reported to be hydrolyzed by water.
- Precipitation: White precipitates of the test chemical were observed by unaided eyes at 4.9 μg/plate and higher in the absence of S9 and at 313 μg/plate and higher in the presence of S9 (Dose-finding assay); White precipitates of the test chemical were observed by unaided eyes at 20 μg/plate and higher in the absence of S9 and at 156 μg/plate and higher in the presence of S9 (Main assay).
RANGE-FINDING/SCREENING STUDIES: In the dose-finding assay, the highest dose was set at 5000 μg/plate, and a total of 7 doses were set with a common ratio of 4. Based on these results, the highest dose in the main assay was set at 313 μg/plate, and a total of 5 doses with a common ratio of 2, including at lease one dose producing precipitation.
COMPARISON WITH HISTORICAL CONTROL DATA: Results were check with the laboratories historical control data. - Remarks on result:
- other: Dose-finding assay
Any other information on results incl. tables
Validity of assays
- Positive control chemicals increased revertant colonies more than twice of the solvent control value of each strain, indicating the assays were performed properly.
- No bacterial growth due to contamination was observed in the sterility test in both the range-finding assay and the main assay.
- The test chemical did not increase the number of revertant colonies 2-fold or more compared to the solvent control value both in the presence and absence of metabolic activation in any of the strains.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
Based on the above results, it was concluded that Ac-GTB was not mutagenic under the test conditions of this study.
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.