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EC number: 948-406-5 | CAS number: -
- 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:
- 28-03-2019 to 13-05-2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3a,4,7,7a-tetrahydro-1H-indene
- EC Number:
- 221-260-3
- EC Name:
- 3a,4,7,7a-tetrahydro-1H-indene
- Cas Number:
- 3048-65-5
- Molecular formula:
- C9H12
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-1H-indene
- Reference substance name:
- 4-vinylcyclohexene
- EC Number:
- 202-848-9
- EC Name:
- 4-vinylcyclohexene
- Cas Number:
- 100-40-3
- Molecular formula:
- C8H12
- IUPAC Name:
- 4-vinylcyclohexene
- Reference substance name:
- Cyclopentadiene
- EC Number:
- 208-835-4
- EC Name:
- Cyclopentadiene
- Cas Number:
- 542-92-7
- Molecular formula:
- C5H6
- IUPAC Name:
- cyclopenta-1,3-diene
- Reference substance name:
- cis-1,2-Divinylcyclobutane
- Cas Number:
- 2422-85-7
- Molecular formula:
- C8H12
- IUPAC Name:
- cis-1,2-Divinylcyclobutane
- Reference substance name:
- Ethylbenzene
- EC Number:
- 202-849-4
- EC Name:
- Ethylbenzene
- Cas Number:
- 100-41-4
- Molecular formula:
- C8H10
- IUPAC Name:
- ethylbenzene
- Reference substance name:
- 5-vinylnorborn-2-ene
- EC Number:
- 221-259-8
- EC Name:
- 5-vinylnorborn-2-ene
- Cas Number:
- 3048-64-4
- Molecular formula:
- C9H12
- IUPAC Name:
- 5-vinylbicyclo[2.2.1]hept-2-ene
- Reference substance name:
- Cycloocta-1,5-diene
- EC Number:
- 203-907-1
- EC Name:
- Cycloocta-1,5-diene
- Cas Number:
- 111-78-4
- Molecular formula:
- C8H12
- IUPAC Name:
- cycloocta-1,5-diene
- Reference substance name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- EC Number:
- 201-052-9
- EC Name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- Cas Number:
- 77-73-6
- Molecular formula:
- C10H12
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene,
- Reference substance name:
- 3a,4,7,7a-tetrahydro-4-methyl-1H-indene
- EC Number:
- 231-021-5
- EC Name:
- 3a,4,7,7a-tetrahydro-4-methyl-1H-indene
- Cas Number:
- 7413-02-7
- Molecular formula:
- C10H14
- IUPAC Name:
- 4-methyl-3a,4,7,7a-tetrahydro-1H-indene
- Reference substance name:
- Combination of: 6-(cyclohex-3-en-1-yl)bicyclo[2.2.1]hept-2-ene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4-methanonaphthalene 6-vinyl-1,4,4a,5,6,7,8,8a-octahydro-1,4-methanonaphthalene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene 2,2'-bi(bicyclo[2.2.1]heptane-5,5'-diene) 3a,4,4a,5,8,8a,9,9a-octahydro-1H-5,8-methanocyclopenta[b]naphthalene 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene
- Molecular formula:
- C13H18 to C14H18
- IUPAC Name:
- Combination of: 6-(cyclohex-3-en-1-yl)bicyclo[2.2.1]hept-2-ene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4-methanonaphthalene 6-vinyl-1,4,4a,5,6,7,8,8a-octahydro-1,4-methanonaphthalene 2-vinyl-1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene 2,2'-bi(bicyclo[2.2.1]heptane-5,5'-diene) 3a,4,4a,5,8,8a,9,9a-octahydro-1H-5,8-methanocyclopenta[b]naphthalene 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene
- Reference substance name:
- 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene OR 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4:5,8-dimethanofluorene
- Molecular formula:
- C14H18 to C15H18
- IUPAC Name:
- 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4-methanofluorene OR 4,4a,4b,5,8,8a,9,9a-octahydro-1H-1,4:5,8-dimethanofluorene
- Reference substance name:
- 3a,4,4a,5,8,8a,9,9a-octahydro-4,9:5,8-dimethano-1H-benz[f]indene
- EC Number:
- 230-512-1
- EC Name:
- 3a,4,4a,5,8,8a,9,9a-octahydro-4,9:5,8-dimethano-1H-benz[f]indene
- Cas Number:
- 7158-25-0
- Molecular formula:
- C15H18
- IUPAC Name:
- 3a,4,4a,5,8,8a,9,9a-octahydro-1H-4,9:5,8-dimethanocyclopenta[b]naphthalene
- Reference substance name:
- Tetramers of cyclopentadiene and 1,3-butadiene
- Molecular formula:
- C16H24 to C20H24
- IUPAC Name:
- Tetramers of cyclopentadiene and 1,3-butadiene
- Test material form:
- liquid
- Details on test material:
- Light brown liquid.
Batch number 776809
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
impurity 1
Constituent 10
Constituent 11
Constituent 12
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: BIBRA (1987) and Trinova Biochem GmbH (2017)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Pre-prepared using standardised in house procedures. Lot no PB/βNF S9 28/10/18. Certificate of efficacy included in study report
- concentration or volume of S9 mix and S9 in the final culture medium : 10% then 0.5mL of mix per plate
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Yes - Test concentrations with justification for top dose:
- Plate incorporation method: 1.5, 5, 15, 50, 150, 500, 1500 and 5000µg/plate where top dose is maximum recommended dose in guideline
Pre-incubation method used results from plate incorporation method. Tested doses the same except for TA100 which used 0.5, 1.5, 5, 15, 50, 150, 500 and 1500µg/plate. Selection criteria was to achieve four non-toxic doses and see cytotoxicity at top dose - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- no
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate)
- Number of independent experiments : plate incorporation and pre-incubation methods used.
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 0.9 to 9.0E9 bacteria/mL
- Test substance added in medium; in agar (plate incorporation); preincubation; in suspension;
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48-72hrs
- Evaluation criteria:
- Dose related increase in mutation frequency, reproducible increases, biological relevance versus historic controls, increase >2x compared to concurrent solvent controls (TA98, 100, uvRA) and >3x fpr TA1535 and 1537 (especiall if outside of historic controls), statistical significance
- Statistics:
- As per UKEMS (Mahon, 1989) , confirmed usiing Dunnetts regression analysis where statisticlaly significant increases seen.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Reduced growth of background lawn from 1500µg/plate (both with and without S9 using pre-incubation method and 1500µg/plate and 500µg/plate with and without S9 respectively in the plate incorporation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Compared to concurrent solvent control: Plate incorporation method 24x and 51x increase with and without metabolic activation respectively , preincubation method 25x and 70x increase with and without metabolic activation respectively.
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Reduced growth of background lawn from 5000µg/plate and 500µg/plate with and without S9 respectively using pre-incubation method and 1500µg/plate and 150µg/plate with and without S9 respectively in the plate incorporation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Compared to concurrent solvent control: Plate incorporation method 35x and 40x increase with and without metabolic activation respectively, preincubation method 23x increase both with and without metabolic activation.
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Reduced growth of background lawn from 1500µg/plate both with and without S9 respectively using pre-incubation method and 150µg/plate both with and without S9 respectively in the plate incorporation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Compared to concurrent solvent control: Plate incorporation method 6.5x and 4.6x increase with and without metabolic activation respectively, preincubation method 5.3x and 13x increase with and without metabolic activation respectively.
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Reduced growth of background lawn from 500µg/plate both with and without S9 respectively using pre-incubation method and 500µg/plate and 50µg/plate with and without S9 respectively in the plate incorporation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Compared to concurrent solvent control: Plate incorporation method 16x and 4.6x increase with and without metabolic activation respectively, preincubation method 13x and 5.3x increase with and without metabolic activation respectively.
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Reduced growth of background lawn from 1500µg/plate both with and without S9 respectively using pre-incubation method and 5000µg/plate and 150µg/plate with and without S9 respectively in the plate incorporation method.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- Compared to concurrent solvent control: Plate incorporation method 8.3x and 25x increase with and without metabolic activation respectively, preincubation method 3.6x and 43x increase with and without metabolic activation respectively.
- Additional information on results:
- - Signs of toxicity: Cytotoxicity was taken to be a signficant reduction in the background lawn of more than 50%. Cytotoxicity seemed higher in the pre-incubation assay compared to the plate incorporation assay.
One statistically significant value was noted (WP2uvrA at 5µg/plate without S9). However, this was within the historical control range for the strain and was therefore considered not of biological relevance.
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic in bacterial reverse mutation assay
- Executive summary:
In a guideline and GLP bacterial reverse mutation assay, the UVCB substance THI-TM showed no evidence of mutagenic potential both with and without metabolic activation up to cytotoxic concentrations.
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