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EC number: 263-170-7 | CAS number: 61791-38-6
- 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-norcoco alkyl derivs.
- EC Number:
- 263-170-7
- EC Name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-norcoco alkyl derivs.
- Cas Number:
- 61791-38-6
- Molecular formula:
- an exact molecular formula cannot be provided for an UVBC, most representative example: C16H32N2O
- IUPAC Name:
- 2-(2-heptadecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol; 2-(2-pentadecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol; 2-(2-tridecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol; 2-(2-undecyl-4,5-dihydro-1H-imidazol-1-yl)ethan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Identification: 1H-Imidazole-1-Ethanol, 4,5-Dihydro-2-NorcocoAlkyl Deriv.
CAS No: 61791-38-6
EC No: 263-170-7
Physical state/Appearance: Orange coloured viscous liquid
Batch Number: FPAC1717924
Purity: 100%
Expiry Date: 29 April 2021
Storage Conditions: Room temperature in the dark
No correction for purity was required.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Test for Mutagenicity: Experiment 1 – Plate Incorporation Method
The test item was tested using the following method. The maximum concentration was 5000 µg/plate (the OECD TG 471 maximum recommended dose level). Eight concentrations of the test item (1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method.
Test for Mutagenicity: Experiment 2 – Pre-Incubation Method
The dose range used for Experiment 2 was determined by the results of Experiment 1 and was as follows:
Salmonella strains (without S9): 0.15, 0.5, 1.5, 5, 15, 50, 150 µg/plate.
E.coli strain WP2uvrA (with and without S9) and all Salmonella strains (with S9): 0.5, 1.5, 5, 15, 50, 150, 500 µg/plate.
Seven test item concentrations per bacterial strain were selected in Experiment 2 in order to achieve both four non-toxic dose levels and the toxic limit of the test item following the change in test methodology from plate incorporation to pre-incubation. - Vehicle / solvent:
- dimethyl formamide
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene (2AA)
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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
- Untreated negative 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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
- Untreated negative 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Experiment 1 (plate incorporation)
The maximum dose level of the test item in the first experiment was selected as the OECD TG 471 recommended dose level of 5000 μg/plate.
The test item induced a toxic response in the first mutation test with weakened bacterial background lawns initially noted in the absence of S9-mix from 150 μg/plate (all Salmonella strains) and 500 μg/plate (WP2uvrA). In the presence S9-mix, weakened bacterial background lawns were noted from 500 μg/plate (all tester strains).
No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of metabolic activation (S9-mix).
There were no biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix). Small, statistically significant increases in revertant colony frequency were observed at 1.5 μg/plate (TA100 dosed in the absence of S9-mix) and 15 μg/plate (TA98 dosed in the presence of S9-mix). However these responses were withinthe in-house historical vehicle/untreated control ranges for the tester strains and were, therefore considered of no biological relevance.
Experiment 2 (pre-incubation)
Based on the results of Experiment 1, the toxic limit of the test item was employed as the maximum concentration in the second mutation test.
The test item induced a stronger toxic response in the second mutation test with weakened bacterial background lawns initially noted in the absence of S9-mix from 15 μg/plate (all Salmonella strains) and 150 μg/plate (WP2uvrA). In the presence of S9-mix, weakened bacterial background lawns were initially noted from 150 μg/plate (all Salmonella strains) and at 500 μg/plate (WP2uvrA).
No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of metabolic activation (S9-mix).
There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix).
Applicant's summary and conclusion
- Conclusions:
- In this Reverse Mutation Assay ‘Ames Test’ using strains of Salmonella typhimurium and Escherichia coli (OECD TG 471) the test item 1H-Imidazole-1-Ethanol, 4,5-Dihydro-2-Norcoco Alkyl Deriv. did not induce an increase in the frequency of revertant colonies at any of the dose levels used either with or without metabolic activation (S9-mix). Under the conditions of this test 1H-Imidazole-1-Ethanol, 4,5-Dihydro-2-Norcoco Alkyl Deriv. was considered to be non-mutagenic.
- Executive summary:
Under the conditions of this test 1H-Imidazole-1-Ethanol, 4,5-Dihydro-2-Norcoco Alkyl Deriv. was considered to be non-mutagenic.
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