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EC number: 686-853-5 | CAS number: 46921-17-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-12-04 to 2009-12-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP, OECD Guideline 471
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- EC Number:
- 686-853-5
- Cas Number:
- 46921-17-9
- Molecular formula:
- C16H31NO
- IUPAC Name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
- Details on test material:
- Other name of 4,4-Dimethyl-2-undecyl-2-oxazoline : cycloceramide
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Physical state : Liquid
Purity : 96%
Storage conditions : 4°C, keep away from daylight and moisture
Method
- Target gene:
- All the bacterial strains used in the Ames test carry a mutant gene that prevents them from synthetizing an essential amino acid (histidine in the case of S.typhimurium).
These strains carry additional mutations which increase their sensitivity to different types of mutagens. All S.typhimurium strains used in the test carry the rfa mutation.
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:
- Chemical. Without metabolic activation S9(-): TA98 : 2-nitrofluorene; TA100 : Sodium Azide; TA102 : Mitomycin C; TA1535 : Sodium Azide; TA1537 : 9-aminoacridine With metabolic activation S9(+): For all Strains : 2-aminoanthracene
- Test concentrations with justification for top dose:
- 5 concentrations (F1 to F5) starting at 5.00µL/plate (F1), based on the solubility profile of the test item (The test item was found to be soluble in corn oil at a concentration of 50µL/mL).
Concentrations F2 to F5 were prepared by 1:3 serial dilutions from the selected F1 concentration. - Vehicle / solvent:
- Without metabolic activation :
TA98 : DMSO
TA100 : H2O
TA102 : H2O
TA1535 : H2O
TA1537 : DMSO
With metabolic activation :
For all Strains : DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- with vehicle as negative control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Corresponding to the negative control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Details on test system and experimental conditions:
- Number of replicate : 3
Number of doses : 5 concentrations (µL/plate) (F1 to F5). F1 = 5,00; F2 = 1,67; F3 = 0,56; F4 = 0,19; F5 = 0,06 and reference item controls.
Negative control : Yes, with vehicle as negative control (H2O or DMSO).
Metabolic activation system : with and without (S9) under the direct incorporation (main study) and the pre-incubation (confirmatory study) procedures.
In the direct incorporation procedure the mixture was immediately poured over a minimal agar medium plate and incubated at 37ºC for 48 hours. Whereas in the pre-incubation procedure, the mixture was incubated for 20 min at 37ºC prior to be poured over the minimal agar medium plate. - Rationale for test conditions:
- The test item was found to be soluble in corn oil at a concentration of 50uL/mL.
5 concentrations (F1 to F5) starting at 5.00uL/plate, based on the solubility profile of the test item.
Concentrations F2 to F5 were prepared by 1:3 serial dilutions from the selected F1 concentration. - Evaluation criteria:
- A result is considered positive whenever the number of revertants of the test item treated plates is increased when compared to the solvent treated plates according to the following criteria:
(See table below in the section "Any other information on materials and methods incl. tables
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Direct incorporation (main test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Pre-incubation (confirmatory test)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- as negative controls
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The bacterial reverse mutation test for the test item Cycloceramide® was considered valid as the following criteria were met:
- The mean solvent control counts complied with Vivotecnia historical data for each strain.
- The mean reference item control counts complied with Vivotecnia historical data for each strain. - Remarks on result:
- other:
- Remarks:
- NON MUTAGENIC / NON PRO-MUTAGENIC
Any other information on results incl. tables
A result is considered positive whenever the number of revertants of the test item treated plates is increased when compared to the solvent treated plates according to the following criteria:
species | strain | criteria |
S. typhimurium | TA98 | 2 fold |
S. typhimurium | TA100 | 2 fold |
S. typhimurium | TA102 | 2 fold |
S. typhimurium | TA1535 | 3 fold |
S. typhimurium | TA1537 | 3 fold |
Applicant's summary and conclusion
- Conclusions:
- Based on the results obtained in this study, it can be concluded that the test item does not induce point mutations or frame-shifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure. None of the concentrations assayed for the test item showed an increase in the R value either with or without S9 metabolic activation regardless of the procedure.
Therefore, the test item Cycloceramide® is considered to be NON MUTAGENIC / NON PRO-MUTAGENIC under the experimental conditions assayed. - Executive summary:
The bacterial reverse mutation test (Ames test) assesses the mutagenic or promutagenic potential of the test item Cycloceramide® in the Salmonella typhimurium TA 1535, 1537, 98, 100 and 102 bacterial strains. The test was performed in accordance with OECD Guideline 471 for the Testing of Chemicals (Bacterial Reverse Mutation Test. Adopted 21st July 1997) and the test Method B13/B14 of Commission Directive 2000/32/EC.
No cytotoxic activity was observed by the test item in the bacterial system.
Five test item concentrations ranged between 5.00 and 0.06 uL/plate were assayed.
None of the concentrations assayed for the test item showed an increase in the R value either with or without S9 metabolic activation regardless of the procedure.
No dose response for the test item Cycloceramide® was observed in none of the tested bacterial strains.
Based on the results obtained in this study, it can be concluded that the test item does not induce point mutations or frame-shifts in the genome of the bacterial strains with or without metabolic activation regardless of the procedure.
Therefore, the test item Cycloceramide® is considered to be NON MUTAGENIC / NON PRO-MUTAGENIC
under the experimental conditions assayed.
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