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EC number: 224-623-4 | CAS number: 4430-31-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 October, 2012 - 01 February, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octahydro-2H-1-benzopyran-2-one
- EC Number:
- 224-623-4
- EC Name:
- Octahydro-2H-1-benzopyran-2-one
- Cas Number:
- 4430-31-3
- Molecular formula:
- C9H14O2
- IUPAC Name:
- octahydro-2H-1-benzopyran-2-one
- Test material form:
- liquid
1
Method
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene
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:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- - Dose range finding test:
TA 100 and WP2uvrA (without and with S9): 50, 150, 500, 1500 and 5000 µg/plate
- Experiment 1:
Due to cytotoxicity in TA 100, the following dose levels were used:
TA 98, TA 100, TA 1535 and TA 1537 (without and with S9): 15, 50, 150, 500, 1500 and 5000 µg/plate
WP2uvrA (without and with S9): 50, 150, 500, 1500 and 5000 µg/plate
- Experiment 2:
The test substance dose range was the same as experiment 1:
TA 98, TA 100, TA 1535 and TA 1537 (without and with S9): 15, 50, 150, 500, 1500 and 5000 µg/plate
WP2uvrA (without and with S9): 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The test substance was immiscible in sterile distllied water but was fully miscible in dimethyl sulphoxide at 50 mg/mL in solubility checks performed in house. Dimethyl sulphoxide was therefore selected as the vehicle.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (50 or 100 µL/plate DMSO)
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: With S9 2-aminoanthracene: 1 µg/plate for TA 100, 2 µg/plate for TA 1535 and TA 1537, 10 µg/plate for WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation. - Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to detrmine the overall result of the study:
1. A dose-related increase in mutant frequency over the range tested (De Serres and Shelby (1979)).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the abobe criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgement about test substance activity. Results of this type will be reported as equivocal.
Results and discussion
Test resultsopen allclose all
- Key result
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- but tested up to and including 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
- In TA 100 toxicity was observed at 5000 µg/plate, both in the absence and presence of S9 in the dose range finder. In strain WP2uvrA no toxicity was observed.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY (MAIN TEST):
- In all Salmonella strains toxicity was observed at 1500 and 5000 µg/plate in the absence of S9-mix and at 5000 µg/plate in the presence of S9-mix. No toxicity was noted to WP2uvrA dosed in the presence of S9-mix although weakened bacterial background lawns were noted to the same strain in the absence of S9-mix. These results were not indicative of toxicity sufficiently severe enough to prevent the test substance being tested up to and including the maximum recommended dose level of 5000 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent pre-incubation experiments, both in the absence and presence of S9-mix up to and including 5000 µg/plate. Adequate negative and positive controls were included. Toxicity was observed in all Salmonella strains at concentrations of 1500 and 5000 µg/plate in the absence of S9-mix and at concentration of 5000 µg/plate in the presence of S9-mix. In E.coli no toxicity was observed at the concentration of 5000 µg/plate in the presence of S9-mix and slight toxicity was observed at the concentration of 5000 µg/plate in the absence of S9-mix. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in E. coli strain WP2uvrA, both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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