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EC number: 800-253-4 | CAS number: 1419212-73-9
- 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:
- 16-01-2013 to 19-03-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guidelines, under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- 2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole
- EC Number:
- 800-253-4
- Cas Number:
- 1419212-73-9
- IUPAC Name:
- 2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole
- Reference substance name:
- Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products
- IUPAC Name:
- Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products
- Reference substance name:
- Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction
- IUPAC Name:
- Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction
- Reference substance name:
- Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from
- IUPAC Name:
- Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from
- Test material form:
- liquid: viscous
- Details on test material:
- Name of test material (as cited in study report): Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from"
Substance type: UVCB
Purity : 100%
Storage conditions : Room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
- Target gene:
- Salmonella typhimurium: histidine
E-coli: tryptophan
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 from rats induced with Phenobarbitone/ß-Naphthoflavone
- Test concentrations with justification for top dose:
- Salmonella species: 1.5, 5, 15, 50, 150, 500 and 1500 ug/plate with and without metabolic activation in preincubation and plate incorporation assay
E. coli: 50, 150, 500, 1500 and 5000 ug/plate with and without metabolic activation in plate incorporation assay; 15, 50, 150, 500, 1500 and 5000 ug/plate with and without metabolic activation in preincubation assay - Vehicle / solvent:
- acetone (100 mg/mL)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA100, TA1535 and WP2uvrA without metabolic activation
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA1537 without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA100, TA1535, TA 1537 and WP2uvrA with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA98 without metabolic acivation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- Positive controls:
- yes
- Remarks:
- for TA98 with metabolic activation
- Positive control substance:
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st test in agar (plate incorporation); 2nd test preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 hours at 37°C
NUMBER OF REPLICATIONS: 3/concentration
DETERMINATION OF CYTOTOXICITY
- Method: growth rate + presence of bacterial background lawn
COLONY COUNT:
Colony counter - Evaluation criteria:
- A test item will be considered mutagenic (positive) in the test system if one or more of these criteria are met
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response). - Statistics:
- Not specified according to UKEMS
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- reduction of bacterial background lawn at 1500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- presence of greasy precipitate did not hinder the evaluation at 1500 and 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results
negative without metabolic activation
negative with metabolic activation
The test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 as well as in E. coli WP2 uvr A both in presence and absence of metabolic activation. - Executive summary:
The test substance was tested in an Ames test at concentrations of 1.5 to 1500 ug/plate (cytotoxicity obeserved) in the salmonella strains TA98, TA100, TA1535 and TA1537. The concentrations in the test on E. coli WP2 uvr A were 15 -5000 ug/plate. At 1500 and 5000 ug/plate a greasy precipitate was observed, that did not hamper the evaluation. In a plate incorporation and a pre-incubation assay (both performed in triplicate) with and without metabolic activation, the test substance did not induce mutations (base-pair substitution and frame-shift type) in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537, as well as in E. coli WP2 uvr.
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