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EC number: 800-884-5 | CAS number: 1154308-86-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- EC Number:
- 800-884-5
- Cas Number:
- 1154308-86-7
- Molecular formula:
- C11 H23 N1 O2
- IUPAC Name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- Details on test material:
- - Name of test material (as cited in study report): Additol® SXW 6246/90 Coating Additives
- Physical state: Amber Liquid
- Analytical purity: 94.67% (+5.33% water)
- Batch no.: 210129777
- Expiration date of Batch no. 210129777: 28 February 2013
- Storage condition of test material: Ambient, Dark
- Composition of test material, percentage of components: Amides, C8-12, N-(hydroxyethyl) 90622-90-5 (94.67%) and Water 7732-18-5 (5.33%)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 (10%)
- Test concentrations with justification for top dose:
- 17, 50, 167, 500, 1667 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility and acceptable solvent for use with Ames test.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate. Both direct plate incorporation method and preincubation method used
DURATION
- Preincubation period: 20 mins
- Exposure duration: Total exposure 3 days
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Condition of background lawn. - Evaluation criteria:
- S. typhimurium strains TA 1535, TA 1537, and TA 98 and for E. coli WP2uvrA, 2 fold increase over mean concurrent vehicle control value.
S. typhimurium strain TA 100, a 1.5 fold increase over mean concurrent control value. - Statistics:
- No
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
- Remarks:
- at 5000 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- at 5000 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- at 5000 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- at 5000 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- at 5000 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: None
- Other confounding effects: None
RANGE-FINDING/SCREENING STUDIES: Yes
COMPARISON WITH HISTORICAL CONTROL DATA: Not required
ADDITIONAL INFORMATION ON CYTOTOXICITY: In the first test, conducted by the Direct Plate Incorporation Method, toxicity to the bacteria was observed as a thinning of the background lawn of microcolonies, +/- a reduction in revertant colony numbers. This observation was made at the highest concentration of 5000 µg per plate in all strains in the absence of S9 mix and in strains TA 1535, TA 1537 and TA 100 in the presence of S9 mix.
In the second test, conducted by the Pre-incubation Method, toxicity was observed in all the bacterial strains at the 2 highest concentrations of 1667 and 5000 µg per plate, in both the absence and the presence of S9 mix. - Remarks on result:
- other: no mutagenic potential
- Remarks:
- all strains/cell types tested
Any other information on results incl. tables
Tables in attachment (background material).
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the substance was determined to be non-mutagenic in the reverse mutation assay with and without metabolic activation
- Executive summary:
An in vitro study was conducted to investigate the potential of test substance to induce gene mutations Salmonella typhimurium strains, according to OECD Guideline 471, in compliance with GLP. The test substance was tested for mutagenic activity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in Escherichia coli WP2uvrA. Two independent tests were conducted on agar plates in triplicate in the absence and presence of an Aroclor 1254 induced rat liver S9 preparation and the co-factors required for mixed-function oxidase activity (S9 mix). The first test was conducted by the Direct Plate Incorporation Method, while the second test was conducted by the Pre-incubation Method. The test substance was dissolved and diluted in dimethylsulphoxide and was dosed at concentrations ranging from 17 to 5000 µg per plate in both the absence and the presence of S9 mix. The highest concentration represented the maximum concentration recommended by the guideline. Concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the S9 mix. No evidence of mutagenic activity was obtained with any strain in either test. The highest concentrations of the test substance were toxic to the bacteria, especially in the second test based on Pre-incubation Method. No precipitation of the test substance was observed at any of the tested concentrations. Under the conditions of the study, the substance was determined to be non-mutagenic in the reverse mutation assay with and without metabolic activation (Riach, 2012).
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