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EC number: 412-830-4 | CAS number: 1823-59-2 ODPA
- 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:
- 07.11.-18.12.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-oxydiphthalic anhydride
- EC Number:
- 412-830-4
- EC Name:
- 4,4'-oxydiphthalic anhydride
- Cas Number:
- 1823-59-2
- Molecular formula:
- C16H6O7
- IUPAC Name:
- 5-[(1,3-dioxo-1,3-dihydro-2-benzofuran-5-yl)oxy]-1,3-dihydro-2-benzofuran-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in Exp I: 3-5000 µg/plate
Concentration range in Exp II: 1.0-2500 µg/plate
According to the results of the pre-experiment - Vehicle / solvent:
- Solvent: Dimethylsulfoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- A. dest
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-NOPD
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabilic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation) in Experiment I and pre-incubation in
Experiment II.
DURATION
- Exposure duration: 48h at 37°C
NUMBER OF REPLICATIONS: 3
ACCEPTANCE CRITERIA:
A test is considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100 and TA 102)
- the negative control plates (A. dest.) with and without S9 mix are within the historical control data
range of the test facility
- corresponding background growth on solvent control, negative control and test plates is observed.
- the positive controls show a distinct enhancement of revertant rates over the control plate
- at least five different concentrations of each tester strain are analyzable - Rationale for test conditions:
- these are according to the OECD guideline 471
- Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean
values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one
tester strain with or without metabolic activation
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher as co
mpared to the reversion rate of the solvent control
A test item producing neither a dose related increase in the number of revertants nor a reproducible
biologically relevant positive response at any of the dose groups is considered to be non-mutagenic
in this system. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the
interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- 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:
- 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 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No biologically relevant increases in revertant colony numbers of any of the five tester strains were
observed
Any other information on results incl. tables
Positive controls produced the expected increases in the number of revertants.
Applicant's summary and conclusion
- Conclusions:
- The test item is considered to be non-mutagenic in this bacterial reverse mutation assay
- Executive summary:
In the current study the potential of the test item to induce gene mutations according to the plate
incorporation test (experiment I) and the pre-incubation test (experiment II) was assessed in the Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102 with and without matabolic activation, and according to OECD TG 471 and in compliance to GLP.
In two independent experiments several concentrations of the test item were used.
The concentrations, including the controls, were tested in triplicate.
The following concentrations of the test item were prepared and used in the experiments:
Exp. I: 3.16, 10.1, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
Exp. II: 1.0, 3.16, 10.0, 31.6, 100, 316, 1000 and 2500 μg/plate
No precipitation of the test item was observed in any tester strain used in experiment I and II (with
and without metabolic activation).
Toxic effects of the test item were noted in all of the five tester strains evaluated in experiment I and II.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were
observed at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.
In experiment I in the tester strain TA98 a mutation factor of 2.0 was observed at a concentration of 3.16 μg/plate (with metabolic activation).
However, the correspondant revertant colony number was within the range of the historical negative control data and no dose-response relationship was observed. Thus, the effect was considered as not biologically relevant.
All criteria of validity were met.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
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