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EC number: 262-114-9 | CAS number: 60239-68-1
- 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:
- From February 28, 2017 to March 23, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)undec-10-enamide
- EC Number:
- 262-114-9
- EC Name:
- N,N-bis(2-hydroxyethyl)undec-10-enamide
- Cas Number:
- 60239-68-1
- Molecular formula:
- C15H29NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)undec-10-enamide
- Test material form:
- liquid
- Details on test material:
- The test substance is the reaction product of 10-undecenoicacid methyl ester with diethanolamine (DEA). The methanol formed in the process is removed by distillation. The final product is a clear liquid at 20 °C and 101.3 kPa.
Constituent 1
- Specific details on test material used for the study:
- Batch no.: S016419544
Purity: 90.60%
Apearance: yellow, clear liquid
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal preparation derived from Aroclor 1254-induced rat liver (S9-mix)
- Test concentrations with justification for top dose:
- Six concentrations ranging from 3.16 to 1000 μg/plate (3.16, 10.0, 31.6, 100, 316 and 1000 μg per plate) based on a preliminary test where cytotoxicity was observed from 1000 µg/plate and onwards.
- Vehicle / solvent:
- DMSO (as well as ethanol and water)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- - The potential of the test substance to induce gene mutations was examined in 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
(Plates: 3 per concentration and experiment; the final cell density was approximately 10E08 - 10E09 cells/mL.)
- The test substance was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted starting at a concentration of 1000 μg/plate in both experiments. Hence, 1000 μg per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
- Main study
Six concentrations ranging from 3.16 to 1000 μg test substance/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation. - Rationale for test conditions:
- Preliminary test
- Evaluation criteria:
- Bacteria colonies were counted employing the Biosys Biocount 5000 system. Occurrence of test substance precipitation would have been documented after visual inspection of the cultures with the unaided eye. Cytotoxicity is defined as reduction in the number of colonies by more than 50% compared to the solvent control and/or a scarce background lawn.
- Statistics:
- p ≤ 0.05, U-test according to MANN and WHITNEY compared to the solvent control
(concentration-related increase over the range tested in the number of the revertants per plate, reproducibility)
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella t. TA98, TA00, TA102, TA1535 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the highest dose of 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Cytotoxicity
In the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the top concentration of 1000 μg/plate in all test strains.
- Mutagenicity
No increase in revertant colony numbers as compared with control counts was observed for the test substance, tested up to the cytotoxic concentration of 1000 μg/plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).
- The positive control substances showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system. The results of the negative and positive control cultures are within the range of the historical data.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance did not induce any increase in the number of revertants and was therefore considered not mutagenic in Salmonella typhimurium.
- Executive summary:
A study was conducted to determine the in vitro genetic toxicity of the tes substance according to OECD Guideline 471 and EU Method B13/14, in compliance with GLP. The potential of the test substance to induce gene mutations was examined in 5 Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test. The test substance was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 μg/plate were tested. Pronounced cytotoxicity was noted starting at a concentration of 1000 μg/plate in both experiments. Hence, 1000 μg per plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test. In the main study, six concentrations ranging from 3.16 to 1000 μg test substance/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the top concentration of 1000 μg/plate in all test strains. No increase in revertant colony numbers as compared with control counts was observed for the test substance, tested up to the cytotoxic concentration of 1000 μg/plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test). The positive control substances showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system. The results of the negative and positive control cultures are within the range of the historical data. Under the study conditions, the test substance did not induce any increase in the number of revertants and was therefore considered not mutagenic in Salmonella typhimurium (Spruth, 2017).
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