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EC number: 838-724-1 | CAS number: 94568-76-0
- 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:
- 11 - 26 Jul 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- - Only one plate was used per concentration - 2-Aminoanthracene was used as the sole indicator for the efficacy of the S9-mix
- GLP compliance:
- no
- Remarks:
- in-house safety study
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine
- EC Number:
- 838-724-1
- Cas Number:
- 94568-76-0
- Molecular formula:
- C12H17N
- IUPAC Name:
- 1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for the E.coli strain)
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:
- Type and composition of metabolic activation system:
- source of S9: Oriental Yeast Co., Ltd (Lot no. 12041901) - Test concentrations with justification for top dose:
- First experiment: 15, 50, 150, 500, 1500, 5000 μg/plate with and without metabolic activation (recommended maximum test concentration for soluble non-cytotoxic substances according to OECD 471)
Additional tests; 15.6, 31.3, 62.5, 125, 250, 500 μg/plate with metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: As the test substance does not dissolve in water at 50 mg/mL or higher, but did dissolve in DMSO at 50 mg/mL or higher and a 5% solution was stable for 24 hours at room temperature, DMSO was chosen as the solvent.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other:
- Remarks:
- 1) TA 100 0.01 µg/plate, TA 98 0.1 µg/plate (-S9);
2) TA 1537 1.0 µg/plate (-S9);
3) TA 100 1.0 µg/plate TA 1535 TA 1537 2.0 µg/plate WP2uvrA10 µg/plate TA 98 0.5 µg/plate (+S9)
- a "negative control" not further specified was used
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): 1st experiment: one plate / dose; 2nd experiment: two plates / dose
- Number of independent experiments: 2 (in the second experiment, only the strain with a positive outcome was tested again)
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added: 0.1 mL/plate; preincubation
The test substance was weighed, prepared and tested under yellow light.
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 20 min at 37 °C
- Exposure duration/duration of treatment: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: decrease in the number of revertant colonies per plate - Evaluation criteria:
- Criteria for a positive result were dose dependency and a two-fold or greater increase in the number of revertant colonies in the group treated with the test substance compared to the number of revertant colonies in the negative control group. Otherwise the result was judged to be negative. If a positive result was found, comparative activity value was calculated.
- Statistics:
- Mean values were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1st experiment: at 150 - 5000 μg/plate; 2nd experiment 250 and 500 µg/plate; precipitation in the 1st experiment at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1st experiment: at 150 - 5000 μg/plate; precipitation in the 1st experiment at 1500 µg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Remarks:
- 1st experiment: at 500 - 5000 μg/plate; precipitation in the 1st experiment at 1500 µg/plate and higher (-S9) and at 5000 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Remarks:
- 1st experiment: at 150 - 5000 µg/plate (-S9) and 500 - 5000 μg/plate (+S9); precipitation in the 1st experiment at 1500 µg/plate and higher (-S9) and at 5000 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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
- Remarks:
- 1st experiment: at 150 - 5000 μg/plate; precipitation in the 1st experiment at 1500 µg/plate and higher (-S9) and at 5000 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- 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:
- cytotoxicity
- Remarks:
- 1st experiment: at 500 - 5000 μg/plate; precipitation in the 1st experiment at 1500 µg/plate and higher (-S9) and at 5000 µg/plate (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test substance does not dissolve in water at 50 mg/mL or higher.
- Precipitation: Precipitation of the test substance (oil droplets) was observed in the first experiment at 1500 µg/plate and higher (-S9). No precipitation was observed in the second experiment.
STUDY RESULTS:
In the first experiment, there was a two-fold or greater increase in the number of revertant colonies observed for TA100 strain (+S9) compared to the negative control, and the increase was seen to be dose-dependent. The increase in the number of revertant colonies observed for TA100 strain (-S9), TA1535 strain (±S9), WP2 uvrA strain (±S9), TA98 strain (±S9) and TA1537 strain (±S9) were less than two-fold compared to the negative control. The positive controls induced a two-fold or greater increase in the number of revertant colonies compared to the negative control for each strain, showing the study was properly executed.
Bacterial growth inhibition by the test substance was found at 150, 500 or 5000 µg/plate with or without metabolic activation (depending on the strain).
A second experiment was carried out to replicate the positive result for TA100 strain (+S9). The result was again a two-fold or greater increase in the number of revertant colonies compared to the negative control, and the increase was found to be dose-dependent. The positive controls induced two-fold or greater increases in the number of revertant colonies compared to the negative control for each strain, showing the study was properly executed. Bacterial growth inhibition by the test substance was found at 250 and 500 µg/plate.
Thus, the results of the experiments showed that the positive result for TA100 strain (+S9) is replicable (please refer to the result tables under 'any other information on results incl. tables' for detailed information).
HISTORICAL CONTROL DATA
- Positive historical control data: not given in study report
- Negative (solvent/vehicle): not given in study report
Any other information on results incl. tables
Table 1: Results of the first experiment
Metabolic activation Y/N | Dose of test substance (μg/plate) | Number of reverse mutations (colony count/plate) | |||||
Base pair substitution | Frame shift | ||||||
TA 100 | TA 1535 | WP2 uvrA | TA 98 | TA 1537 | |||
S9 mix (–) | Negative control | 86 | 10 | 31 | 14 | 4 | |
15 | 89 | 10 | 34 | 13 | 4 | ||
50 | 89 | 10 | 26 | 14 | 4 | ||
150 | 88* | 9* | 29 | 13* | 3 | ||
500 | 0* | 0* | 0* | 0* | 1* | ||
1500† | 0* | 0* | 0* | 0* | 0* | ||
5000† | 0* | 0* | 0* | 0* | 0* | ||
S9 mix (+) | Negative control | 130 | 9 | 34 | 21 | 17 | |
15 | 134 | 10 | 31 | 26 | 13 | ||
50 | 223 | 7 | 36 | 27 | 11 | ||
150 | 324* | 6* | 37 | 32 | 9 | ||
500 | 0* | 6* | 20* | 0* | 3* | ||
1500† | 0* | 0* | 0* | 0* | 0* | ||
5000† | 0* | 0* | 0* | 0* | 0* | ||
Positive controls | none | Name | AF-2 | NaN3 | AF-2 | AF-2 | ICR-191 |
Dose (µg/plate) | 0.01 | 0.5 | 0.01 | 0.1 | 1.0 | ||
Colony count / plate | 625 | 562 | 149 | 476 | 3220 | ||
none | Name | 2AA | 2AA | 2AA | 2AA | 2AA | |
Dose (µg/plate) | 1.0 | 2.0 | 10.0 | 0.5 | 2.0 | ||
Colony count / plate | 884 | 299 | 1098 | 319 | 135 |
* growth inhibition was noted
† precipitation was noted
Positive controls
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: Sodium azide
ICR-191: 6-chloro-9-[3-(2-chloroethylamino)-propylamino]-2-methoxyacridine dihydrochloride
2AA: 2-aminoanthracene
Table 2: Results of the second experiment
Metabolic activation Y/N | Dose of test substance (μg/plate) | Number of reverse mutations (colony count/plate) | |
Base pair substitution | |||
TA 100 | |||
S9 mix (–) | Negative control | 97 103 (100) | |
S9 mix (+) | Negative control | 128 115 (122) | |
15.6 | 126 130 (128) | ||
31.3 | 200 193 (197) | ||
62.5 | 247 223 (235) | ||
125 | 294 302 (298) | ||
250 | 224* 225* (225) | ||
500 | 0* 0* (0) | ||
Positive controls | none | Name | AF-2 |
Dose (µg/plate) | 0.01 | ||
Colony count / plate | 617 668 (643) | ||
none | Name | 2AA | |
Dose (µg/plate) | 1.0 | ||
Colony count / plate | 896 931 (914) |
Number in brackets is average value of colony count on each plate.
* growth inhibition was noted
Positive controls
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
2AA: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance 1,1,3-trimethylindan-4-amine has mutagenic potential (positive result).
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