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EC number: 940-875-4 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008/06/24 to 2008/07/24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD 471 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Esterification products of dihydrofuran-2,5-dione, C16-24 (even numbered) alkenyl with propane-1,2,3-triol and propane-1,2,3-triol oligomers
- EC Number:
- 940-875-4
- Molecular formula:
- C3H8O3 - C99H182O20
- IUPAC Name:
- Esterification products of dihydrofuran-2,5-dione, C16-24 (even numbered) alkenyl with propane-1,2,3-triol and propane-1,2,3-triol oligomers
- Test material form:
- other: viscous amber liquid
- Details on test material:
- - Physical state: amber liquid or dark orange extremely viscous liquid
- Analytical purity: >99%
- Storage condition of test material: room temprature in the dark without dessicant
Constituent 1
Method
- Target gene:
- Histidine and tryptophan
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/beta-naphthoflavone induced S9
- Test concentrations with justification for top dose:
- 0, 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 ug/plate in the initial test
0, 50, 150, 500, 1500 and 5000 ug/plate in the confirmatory test - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- 1000 ug/plate for E.coli
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 1.0 ug/plate for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 1.0 ug/plate for TA100 and TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 1 ug/plate for Salmonella, 10 ug/plate for E.coli
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation;
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 to 72 hours
- Expression time (cells in growth medium):
NUMBER OF REPLICATIONS: 3 plates per dose level
NUMBER OF CELLS EVALUATED: at least 10E9 per mL
DETERMINATION OF CYTOTOXICITY
- Method: evaluation of the growth of the background lawn - Evaluation criteria:
- For a test article to induce a positive response in the assay, it must cause a dose-related increase in the mean number of revertants per plate in at least one tester strain. The mean number of revertants per plate at the peak of the dose response should be equal to or greater than 2.0 times the mean vehicle control values for tester strains TA98, TAlOO and WP2 uvrA (pKMlO1) and equal to or greater than 3.0 times the mean vehicle control values for tester strains TA1535 and TA1537.
- Statistics:
- None used
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Control data were within the range of the historical dataset.
Dose formulation analysis confirmed the concentrations of representative concentrations of the test item formulation series. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The summary tables of the results of the two experiments are given in the attachment.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test, at up to the maximum recommended dose level. - Executive summary:
The purpose of this study was to evaluate the mutagenic potential of GTS26437 by the Bacterial Mutation Test (GLP Ames). The study was conducted at BioReliance, Rockville, MD according to Good Laboratory Practice regulations with Emily W. Dakoulas, B.S., serving as the Study Director. The Study Director signed the protocol on 24 June 2008. The experimental period began on 26 June 2008 and ended on 24 July 2008.
The test article, GTS26437, was tested in the bacterial reverse mutation assay using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvrA (pKM101) in the presence and absence ofAroclor-induced rat liver S9. The assay was performed in two phases, using both the plate incorporation and the preincubation methods. The first phase, the initial mutagenicity assay via the preincubation method, was used to establish the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, the confirmatory mutagenicity assay via the plate incorporation method, was used to evaluate and confirm the mutagenic potential of the test article.
Dimethyl sulfoxide was selected as the solvent of choice based on the Sponsor’s request, solubility of the test article and compatibility with the target cells. Per the Sponsor, the solution was to be sonicated at a minimum of 20 minutes prior to use. In the solubility test, the test article formed a soluble and clear solution in dimethyl sulfoxide at approximately 400 mg/mL with sonication at approximately 25°C for 70 minutes.
In the initial mutagenicity assay, using the preincubation method, the maximum dose tested was 5000 ug per plate; this dose was achieved using a concentration of 100 mg/mL and a 50 uL plating aliquot. In the initial mutagenicity assay, the dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 ug per plate. No positive mutagenic responses were observed. Neither precipitate nor toxicity was observed. Non-dose responsive increases were observed with tester strain TA98 (1.9-fold) in the presence of S9 activation and with tester strain TA1537 (2.0-fold) in the absence of S9 activation. These were not considered indicative of mutagenic activity the responses were a result of the vehicle control value being on the low end of the acceptable range for TA98 and a single elevated plate count for TA1537. Based on the findings of the initial mutagenicity assay, the maximum dose plated in the confirmatory mutagenicity assay was 5000 ug per plate. In the confirmatory mutagenicity assay, using the plate incorporation method, no positive mutagenic responses were observed with any of the tester strains in the presence or absence of S9 activation. The dose levels tested were 50, 150, 500, 1500 and 5000 ug per plate. Neither precipitate nor toxicity was observed.
Under the conditions of this study, test article GTS26437 was concluded to be negative with Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 wrA (pKM101) in the presence and absence of Aroclor-induced rat liver S9.
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