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EC number: 217-062-1 | CAS number: 1732-96-3
- 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:
- The study was conducted between 3 May 2007 and 20 June 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethylene bis[1,3-dihydro-1,3-dioxoisobenzofuran-5-carboxylate]
- EC Number:
- 217-062-1
- EC Name:
- Ethylene bis[1,3-dihydro-1,3-dioxoisobenzofuran-5-carboxylate]
- Cas Number:
- 1732-96-3
- Molecular formula:
- C20H10O10
- IUPAC Name:
- 2-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyloxy)ethyl 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylate
- Reference substance name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- EC Number:
- 209-008-0
- EC Name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- Cas Number:
- 552-30-7
- Molecular formula:
- C9H4O5
- IUPAC Name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- Reference substance name:
- not assignable
- IUPAC Name:
- not assignable
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- Substance referred to as RIKACID TMEG-100
Chemical name is given as 1,2,4-Benzenetricarboxylic acid, ester with 1,2-ethanediol, but substance is actually Ethylene bis[1,3-dihydro-1,3-dioxoisobenzofuran-5-carboxylate]
Lot No. 0020
CAS No. 71342-70-6
Appearance: Powder of white color
Purity: 99. 2%
Method
- Target gene:
- The histidine operon in the Salmonella typhimurium strains
The tryptophan operon in the Escherichia coli strains
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from the liver of rats induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- The preliminary dose range-finding test was performed at 5 dose levels of the test substance, 312.5, 625, 1250, 2500 and 5000 μg/plate including negative and strain-specific positive control groups.
As a result of preliminary dose range-finding test, cytotoxicity and deposition were not observed in all strains in the absence and presence of metabolic activation.
According to the preliminary dose range-finding test, the highest dose in bacterial reverse mutation test was selected as 5000 μg/plate in the absence and presence of metabolic activation and was sequentially diluted by a geometric ratio of 2 to produce 4 additional lower dose levels for respective strains accompanying a negative and positive control. - Vehicle / solvent:
- Through the preliminary solubility test to determine the solubility and dispersion properties of the test substance with reference to the information from the Sponsor, Dimethyl sulfoxide (DMSO, Lot No. : K33960231 504, Merck, USA) was chosen as a vehicle for this study.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5.0 µg/plate for strain TA98
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.5 µg/plate for strains TA100 and TA 1535
- Positive control substance:
- sodium azide
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 80.0 µg/plate for strain TA 1537
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.0 µg/plate for strain WP2uvrA
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.0 µg/plate for strains TA98 and TA100, 2.0 µg/plate for strains TA1535, TA 1537 and WP2uvrA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Cell density at seeding (if applicable): > 1 x 10^9
Each 100 μL of test substance solutions, negative control and positive control was placed in glass tubes sterilized by dry oven. 500 μL of 0.1 mol/L sodium phosphate buffer (pH 7.4) for the treatment in the absence of metabolic activation or 500 μL of
S9 mix for the treatment in the presence of .metabolic activation was added and followed by 100 μL of pre-incubated bacterial suspension (1 x 10^9 cells/mL). This mixture was incubated in a shaking water bath at at 37 °C for 20 minutes. Then, 2 mL of warmed top agar was added and mixed thoroughly with a vortex mixer. Finally, the mixture solution was poured into the minimal glucose agar plate and the overlaid agars were allowed to solidify. After solidification of the top agar, the minimal glucose agar plate was cultured in the incubator (DK-LI020-P, Daiki scientific Co., LTD., Korea) at 37 °C for 48 hours whilst turned over. Duplicate plate of each dose levels of the test substance in the absence and presence of metabolic activation including negative and strain-specific positive controls was used.
Confirmation test
The microbial contaminations were examined as follows.
The highest dose of the test substance or S9 mix was placed in sterilized glass tubes and incubated in a shaking water bath at 37 °C for 20 minutes. 2 mL of warmed top agar was added and mixed thoroughly with a vortex mixer. And, the mixture solution was poured into the nutrient broth agar plate and the overlaid agars were allowed to solidify. The plate was cultured at 37 °C for 48 hours whilst turned over.
Observation and measurement
(1) Colony counting
After the cultivation, the number of revertant colonies was automatically counted by the colony counter (ProtoCOL, SINBIOSIS, UK). If automatic counting is considered not to be performed accurately due to the deposition of the test substance and the growth inhibition of the test strain, the number of revertant colonies was counted macroscopically.
Individual plate count and the mean number of revertant colonies for preliminary dose range-finding test and the bacterial reverse mutation test were recoi:ded at all dose levels of the test substance.
(2) Observation of background lawn
Background lawn was examined by the microscope. - Evaluation criteria:
- The test substance was considered positive if the following conditions are met:
- The number of revertant colonies in each dose level was increased dose dependently at least twice as compared with that of the negative control groups in the absence and presence of metabolic activation. - Statistics:
- Other than the calculations of mean value and standard deviation for the number of colonies, no statistical analysis was not performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 100
- 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
- Species / strain:
- 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 applicable
- Positive controls validity:
- valid
- Additional information on results:
- The preliminary dose range-finding test was performed at 5 dose levels of the test substance, 312.5, 625, 1250, 2500 and 5000 μg/plate including negative and positive control groups.
As a result of preliminary dose range-finding test, cytotoxicity and deposition were not observed in all strains in the absence and presence of metabolic activation. According to the preliminary dose range-finding test, the highest dose in bacterial reverse mutation test was determined to 5 000 μg/plate in the absence and presence of metabolic activation and was sequentially diluted by a geometric ratio of 2 to produce 4 additional lower dose levels including a negative and positive control.
As a result, the number of revertant colonies in the test strains was not increased more than twice as compared with that of the negative control group in the absence and presence of metabolic activation. In addition, cytotoxicity and deposition were not observed in all strains in the absence and presence of metabolic activation. In the positive control, the number of the revertant colonies was significantly increased as compared with that of the negative control group.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test substance, RIKACID TMEG-100 did not showed the mutagenic potential under the conditions of this study.
- Executive summary:
This study was designed to examme the mutagenic potential of RIKACID TMEG-100 using Salmonella typhimurium (TA98, TAlOO, TA1535 and TA1537) and Escherichia coli (WP2uvrA(pKM101))strains.
The preliminary dose range-finding test was performed at 5 dose levels of the test substance, 312.5, 625, 1250, 2500 and 5000 μg/plate including negative and strain-specific positive control groups.
As a result of preliminary dose range-finding test, cytotoxicity and deposition were not observed in all strains in the absence and presence of metabolic activation.
According to the preliminary dose range-finding test, the highest dose in bacterial reverse mutation test was selected as 5000 μg/plate in the absence and presence of metabolic activation and was sequentially diluted by a geometric ratio of 2 to produce 4 additional lower dose levels for respective strains accompanying a negative and positive control.
As a result, the number of revertant colonies in all strains was not increased more than twice as compared with that of the negative control group in the absence and presence of metabolic activation.
The cytotoxicity and deposition were not observed in all strains in the absence and presence of metabolic activation.
In the positive control, the number of revertant colonies was increased as compared with that of the negative control group.
In conclusion, the test substance, RIKACID TMEG-100, did not show the mutagenic potential under the conditions of this study.
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