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EC number: 607-997-7 | CAS number: 26776-30-7
- 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:
- 2007-08-15 to 2007-08-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- Remark: Both TA 102 and E.coli WP2 were not tested (not required by applied version of guideline).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane
- EC Number:
- 607-997-7
- Cas Number:
- 26776-30-7
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane
- Test material form:
- other: viscous liquid
- Details on test material:
- - Appearance: clear, colorless
- Physical state: viscous liquid
Constituent 1
Method
- Target gene:
- mutated gene loci responsible for histidine auxotrophy
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 98, TA100, TA 102, TA 1535, TA 1537
- Additional strain / cell type characteristics:
- other: histidine auxotroph
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 fraction, prepared from male Sprague Dawley rats
- Test concentrations with justification for top dose:
- 20 to 5000 µg/plate
- Vehicle / solvent:
- dimethyl sulfoxide, DMSO (CAS No. 67-68-5)
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethylen glycol dimethylether (EGDE)
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- details see below
- Positive control substance:
- other: without metabolic activation: 4-Nitro-1,2-phenylene (TA 98; TA 1537), Nitrofurantoin (TA100), Sodium azide (TA 1535), Mitomycin C (TA 102); with metabolic activation: Aminoanthracene
- Details on test system and experimental conditions:
- Ames test
SYSTEM OF TESTING
- Metabolic activation system: Aroclor 1254-induced rat liver S9 fraction, prepared from male Sprague Dawley rats
ADMINISTRATION:
- Dosing:
Plate incorporation test: 50/158/500/1581/5000 µg/plate (+/- metabolic activation)
- Number of replicates: 2
- Repeat: preincubation
- Application: solvent ethylen glycol dimethylether (EGDE)
- Positive and negative control groups and treatment:
positive without metabolic activation:
TA 98: 4-Nitro-1,2-phenylene diamine (0.5 µg/plate in dimethyl sulfoxide)
TA 100: Nitrofurantoin (0.2 µg/plate in dimethyl sulfoxide)
TA 102: Mitomycin C (0.2 µg/platein deionized water)
TA 102: Cumene hydroperoxide (50 µg/plate in dimethyl sulfoxide) in plate preincubtion trials
TA 1535: Sodium azide (10 µg/plate in dimethyl sulfoxide)
TA 1537: 4-Nitro-1,2-phenylene diamine (10 µg/plate in dimethyl sulfoxide)
positive with metabolic activation and activity of metabolic system: all strains: 2-aminoanthracene (2.5 µg/plate in dimethyl sulfoxide)
negative: solvent control, 100 µl/plate (pre-incubation: 50 µl/plate)
- Pre-incubation: 20 minutes at 37 °C incubation 48 hours at 37 °C - Evaluation criteria:
- CRITERIA FOR EVALUATING RESULTS:
- negative controls and to be within the expected range, as defined by published data
- positive controls had to show sufficient effects, as defined by the laboratories experience
- titer determinations had to demonstrate sufficient bacterial density in the suspension
Results and discussion
Test results
- 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
- Remarks:
- doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXIC EFFECTS:
- With metabolic activation: None
- Without metabolic activation: None
The positive controls w ere functional.
PRECIPITATION CONCENTRATION: Precipitation occurred at the dose 1581 µ per plate and above
CYTOTOXIC CONCENTRATION (including effects on background lawn):
- Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects - Remarks on result:
- other: other:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
no other results
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test. - Executive summary:
The test item was tested for its ability to induce reverse mutations in an in vitro bacterial system.
Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 were treated with 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane by the Ames test plate incorporation as well as the preincubation method. Five dose levels covering the range between 50 and 5000 µg/plate, in triplicate both with and without the addition of a metabolizing system were employed.
All five bacterial strains exhibited mutagenic response to the appropriate positive control substances. Solvent controls were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range.
Mutagenic activity of the test compound to one or more of the tester strains was not observed in either experiment with and without metabolic activation. Therefore, the test item was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
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