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Diss Factsheets
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EC number: 250-701-2 | CAS number: 31565-19-2
- 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
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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:
- 20 December 1993 - 28 March 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- yes
- Remarks:
- analysis of the test substance mixtures was not performed
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Analysis for stability, uniformity and concentration verification was not performed.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isooctyl acetate
- EC Number:
- 250-701-2
- EC Name:
- Isooctyl acetate
- Cas Number:
- 31565-19-2
- Molecular formula:
- C10H20O2
- IUPAC Name:
- Acetic acid, isooctyl ester
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon Chemical Company Lot Number: 111991
- Expiration date of the lot/batch: 31 October 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in DMSO
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Dr. B. N. Ames, Department of Biochemistry, University of California, Berkeley, California.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenate from the livers of Aroclor 1254 pretreated Sprague Dawley rats (S9)
- Test concentrations with justification for top dose:
- 50, 100, 200, 400, 600 ug/plate initial assay
In a pretoxicity test, toxicity as either a reduction in the number of revertant colonies or a reduction in the background lawn, was observed beginning at test concentration 500 ug/plate with and without metabolic activation. Based on these results 600 ug/plate was selected as the high dose. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The vehicle was considered, under the conditions of the assay, to be stable for the duration of the assay in that it performed in a manner consistent with data from previous studies.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- other: 2-Aminoanthracene and N-Methyl-N-Nitro-N-Nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: three - Evaluation criteria:
- An individual dose is considered positive if the mean colony count on the test plates is equal to or greater than three times the mean number of spontaneous revertants on the vehicle control plates. A positive result for the assay is defined as a reproducible dose-related increase in the number of revertant colonies over at least 3 concentrations of test material including at least one positive dose.
- Statistics:
- The mean plate count and standard deviation for each dose point were determined.
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
To determine the highest dose of test substance to be used in the assay a dose range from 1 to 10,000 ug/plate was tested in TA98. An increase in revertant colonies was not observed at any of the concentrations tested. Toxicity, seen as either a reduction in the number of revertant colonies or a reduction in the background lawn, was observed beginning at test concentration 500 ug/plate with and without metabolic activation. Based on these results, test concentrations of 50 to 600 ug/plate were tested in the initial assay. Due to toxicity in the initial assay a repeat assay was performed using test concentrations of 25 to 400 ug/plate.
In the initial mutagenesis assay, neither a positive response nor a dose related increase was observed for any of the tester strains. Toxicity, either a reduction in the number of revertant colonies or a reduction in the background lawn, was observed for all tester strains with and without metabolic activation. In the repeat mutagenesis assay, neither a positive response nor a dose related increase was observed for any of the tester strains. Toxicity, either a reduction in the number of revertant colonies or a reduction in the background lawn, was observed for all tester strains with and without metabolic activation, except for TA1535 with (+ S9) metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Neither a positive dose nor a dose related increase was observed for any of the tester strains with or without metabolic activation in either the initial or repeat assays. Under the conditions of the assay, MRD-93-688 was not mutagenic for the Salmonella test strains at doses up to and including 600 ug/plate.
- Executive summary:
The microbial mutagenesis assay (Ames Assay), developed by B. N. Ames and coworkers (1975) is a test for the ability of a compound to cause reverse mutation at the histidine locus in bacteria (from nutritional histidine dependence to histidine independence). Five special tester strains of Salmonella typhimurium, which were sensitive to frameshift or base pair mutagens, were employed. Positive test results are considered to provide presumptive evidence of mutagenic potential in mammalian species.
This assay was conducted to determine if Exxate 800 (MRD-93-688) was capable of causing reverse mutations in these special tester strains of bacteria with and without metabolic activation.
The test substance was diluted in DMSO, A toxicity pretest was performed to determine the highest concentration of test substance to be used in the initial assay. Test concentrations of 1 to 10,000 fig/plate were tested with and without metabolic activation in tester strain TA98.
The test substance did not induce an increase in revertant colonies at any of the concentrations tested. Toxicity, seen as either a reduction in the number of revertant colonies or a reduction in the background lawn, was observed beginning at test concentration 500 ug/plate with and without metabolic activation.
Based on these results, test concentrations of 50 to 600 ug/plate were tested in the initial assay. A repeat assay was performed using test concentrations of 25 to 400 ug/plate.
Neither a positive dose nor a dose related increase was observed for any of the tester strains with or without metabolic activation. Therefore, Exxate 800 (MRD-93-688) was not considered to be mutagenic under the various conditions of testing.
Toxicity, as seen by either a reduction in the number of reverent colonies or reduction in the background lawn; was observed for all five tester strains with and without metabolic activation in both the initial and repeat assays, except for tester strain TA1535 with metabolic activation in the repeat assay.
Both the negative and positive controls responded in an appropriate manner.
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