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EC number: 947-782-8 | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The study examines the potential for Reactions product of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid to cause gene mutations in a reverse mutation assay 'Ames Test' using stains of Salmonella typhimurium and Escherichia coli. The study is GLP compliant and is performed according to OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test" and the EU method B13/14 of Commission Regulation. The organisms used in the study are as follows: Salmonella typhimurium (Strains: TA1537; TA98; TA1535; TA100) and Escherichia coli. (Strains:WP2uvrA). The study includes a valid solvent control, negative control and positive control. Controls and test item experiments are performed in triplicate. The results from the experiment show that Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid does not cause gene mutation in any of the bacterial strains used in this experiment.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11/07/2017 - 12/11/2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 0001230562
- Expiration date of the lot/batch: 08/06/2019
- Purity test date: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark.
- Stability under test conditions: Assumed to be stable.
- Solubility and stability of the test substance in the solvent/vehicle: Assumed to be stable and solubility measured (best solvent was tetrahydrofuran).
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None assumed.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: N/A
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: Disolved in solution up to a maximum concentration of 200 mg/mL.
- Final preparation of a solid: Disolved in tetrahydrofuran.
FORM AS APPLIED IN THE TEST: Dissovled in tetrahydrofuran. - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: frame shift mutations
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: base-pair substitutions
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Additional strain / cell type characteristics:
- other: base-pair substitution
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- The maximum concentration was 5000 µg/plate (the maximum recommended dose level).
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tetrahydrofuran.
- Justification: test item had highest solubility in this solvent. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: The plate incorporation method and the pre-incubation method.
DURATION
- Preincubation period: 48 hours.
- Exposure duration: 48 hours .
- Expression time (cells in growth medium): 48 hours .
- Selection time (if incubation with a selection agent): Automated (except at 5000 ug/plate where it was performed manually) at approximately 48 hours.
- Fixation time (start of exposure up to fixation or harvest of cells): N/A.
SELECTION AGENT (mutation assays): reverse mutation.
NUMBER OF REPLICATIONS: 3.
NUMBER OF CELLS EVALUATED: cells growth per plate per bacterial strain per treatment type. - Rationale for test conditions:
- The study was based on the in vitro technique described by Ames et al., (1975), Maron and Ames (1983) and Mortelmans and Zeiger (2000), in which mutagenic effects are determined by exposing mutant strains of Salmonella typhimurium to various concentrations of the test item.
- Evaluation criteria:
- The following criteria were used to determine a positive interaction:
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 (Cariello and Piegorsch, 1996)).
It is stated that a test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- Dunnetts Regression Analysis (* = p < 0.05) to indicate statistical significance.
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
The study examines the potential for Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid to cause gene mutations in a reverse mutation assay 'Ames Test' using stains of Salmonella typhimurium and Escherichia coli. The study is GLP compliant and is performed according to OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test" and the EU method B13/14 of Commission Regulation. The organisms used in the study are as follows: Salmonella typhimurium (Strains: TA1537; TA98; TA1535; TA100) and Escherichia coli. (Strains:WP2uvrA). The study includes a valid solvent control, negative control and positive control. Controls and test item experiments are performed in triplicate. The results from the experiment show that Reaction products of stearic acid, diethylenetriamine and N-aminoethylethanolamine and acetic acid does not cause gene mutation in any of the bacterial strains used in this experiment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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