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EC number: 500-240-0 | CAS number: 68958-77-0
- 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:
- From 10 March, 2004 to 26 March, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride
- EC Number:
- 500-240-0
- EC Name:
- 4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride
- Cas Number:
- 68958-77-0
- Molecular formula:
- UVCB, major component represented by di-functionalised BADGE (HPA-SA-BADGE-SA-HPA): C41H52O16 Other constituents present at >10%: Mono-functionalised BADGE (BADGE-SA-HPA): C35H44O14 Dimers (HPA-SA-BADGE-SA-BADGE-SA-HPA): C66H82O24
- IUPAC Name:
- 2-Propenoic acid, monoester with 1,2-propanediol, polymer with 2-(chloromethyl)oxirane, dihydro-2,5-furandione and 4,4'-(1-methylethylidene)bis[phenol]
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- S. typhimurium: Histidine gene
E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (Aroclor-1254 induced rat liver S9-mix).
- Test concentrations with justification for top dose:
- Dose range finding test: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
Mutation assay: 33, 100, 333, 1000 and 3330 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Test substance was soluble in DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (5 µg/plate in saline for TA 1535)
- Remarks:
- Without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine (60 µg/plate in water for TA1537)
- Remarks:
- Without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: daunomycin (4 µg/plate in saline for TA 98)
- Remarks:
- Without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: methylmethanesulfonate (650 µg/plate in DMSO TA100)
- Remarks:
- Without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitroquinoline-N-oxide (10 µg/plate in DMSO for WP2uvrA)
- Remarks:
- Without metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene in DMSO for all tester strains
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar
DURATION:
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
COLONY COUNTING: The revertant colonies (histidine independent C.q. tryptophan independent) were counted automatically with a Protos model 50000 colony counter or manually, if less than 40 colonies per plate were present. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually.
DETERMINATION OF CYTOTOXICITY
- Method: Reduction of the bacterial background lawn, increase in the size of the microcolonies and reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test substance on the plates was determined. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces at least a 2-fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment. The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
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:
- no 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:
- no 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:
- no 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:
- no 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Dose range finding test: The test substance was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100,333, 1000, 3330 and 5000 µg/plate in the absence and presence of S9-mix.
-Precipitate: The test substance precipitated in the top agar at concentrations of 333 µg/plate and upwards. Precipitation on the plates was observed at the start and at the end of the incubation period at concentrations of 3330 and 5000 µg/plate.
Toxicity: A reduction in the number of revertants equal to the minimal value of the historical control data range is not considered biologically relevant and, therefore, will not be considered cytotoxic. No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
Mutation assay: Based on the results of the dose range finding test, the test substance was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix in two mutation assays. The first mutation experiment was performed with the strains TA1535, TA1537 and TA98 and the second mutation experiment was performed with the strains TA1535, TA1537, TA98, TA100 and WP2uvrA.
-Precipitate: The test substance precipitated in the top agar at concentrations of 333 µg/plate and upwards. Precipitation on the plates was observed at the start and end of the incubation period at the concentration of 3330 µg/plate.
Toxicity: In both mutation assays, there was no reduction in the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in all tester strains in the absence and presence of S9-mix.
Number of revertants: In the first mutation experiment an exceedingly low (3 revertants/plate vs historical mean of 7 revertants/plate) solvent control value resulted in a non-dose-related increase in responses observed at all test levels in tester strain TA1537 without metabolic activation. However, no similar 2-fold increase or any dose-related increases in revertants/plate were observed in TA1537 without metabolic activation in an independently repeated experiment
All other bacterial strains showed negative responses over the entire dose range, i.e. no dose related, two-fold, increase in the number of revertants in two independently repeated experiments. The negative and strain-specific positive control values were within our laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Refer to attached document under 'Attached background material' for details on results.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the substance was found to be non-mutagenic in the bacterial reverse mutation assay.
- Executive summary:
A study was conducted to determine the mutagenic potential of the test substance '4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride' according to OECD Guideline 471 and EU Method B.13/14 (Ames test), in compliance with GLP. Tester strains TA98, TA100, TA1535, TA1537 of Salmonella typhimurium and WP2uvrA of Escherichia coli were exposed to the test substance. The test was performed in two independent experiments in the presence and absence of Aroclor-1254 induced rat liver S9-mix. In the dose range finding test, the substance was tested up to concentrations of 5,000 µg/plate in the strains TA100 and WP2uvrA. The test substance precipitated as of 3,330 µg/plate. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. Based on the results of the dose range finding test, the test substance was tested in the first mutation assay at 33 to 3,330 µg/plate in the absence and presence of 5% (v/v) S9-mix in TA1535, TA1537 and TA98. In the second mutation assay, it was tested at the same concentration range in the absence and presence of 10% (v/v) S9-mix in TA1535, TA1537, TA98, TA100 and WP2uvrA. The test substance precipitated on the plates at 3,330 µg/plate. The bacterial background lawn was not reduced at any of the concentrations and no decrease in the number of revertants was observed. The test substance did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in WP2uvrA both in the absence and presence of S9-metabolic activation, as confirmed in an independently repeated experiment. In this study, the negative and strain-specific control values were within laboratory historical control data ranges, indicating that the conditions were adequate and the metabolic activation system functioned properly. Based on the results, it is concluded that the test substance is not mutagenic in theSalmonella typhimurium and the Escherichia coli reverse mutation assays (Verspeek, 2004).
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