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EC number: 451-900-9 | CAS number: 894406-76-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU- and/or OECD-guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Ltd
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- other: solid gel
- Details on test material:
- - Name of test material: Didecyldimethylammonium carbonate
Constituent 1
Method
- Target gene:
- The study was designed to assess the mutagenic potential of the test material using a bacterial/microsome test system, by exposing histidine auxotrophs of Salmonella typhimurium to various concentrations of the test material.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Prior to master stains being used, characterization checks were carried out to determined the amino-acid requirement, presence of rfa, R factors, uvrB mutation and spontaneous reversion rate.
In this assay, overnight sub-cultures of the appropriate coded stock cultures were prepared nutrient broth (Oxoid Limited; lot number 301083 04/08) and incubated at 37 °C for approximately 10 hours. Each culture was monitored spectrophotometrically for turbidity with titres determined by viable count analysis on nutrient agar plates.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Activated (phenobarbitone/beta-naphthoflavone, 80/100 mg/kg bw/day) rat liver microsomal S9 fraction
- Test concentrations with justification for top dose:
- - Concentrations used for cytotoxicity testing: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
- Concentrations used for genotoxicity testing:
without S9 mix: 0.15, 0.5, 1.5, 5, 15 and 50 µg/plate
with S9 mix: 0.5, 1.5, 5, 15, 50 and 150 µg/plate - Vehicle / solvent:
- - Vehicle used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- mitomycin C
- other: 2-Aminoanthracene; 1,8-Dihydroxyanthraquinone
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- In agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays):
- Histidine
NUMBER OF REPLICATIONS:
- 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- The test material should have induced a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
- Statistics:
- Dunnett's method of linear regression.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
A study was carried out according to EU Method B.13/14, OECD Guideline 471 (Bacterial Reverse Mutation Assay) and EPA OPPTS 870.5100. Salmonella typhimurium strains TA1535, TAl537, TA102, TA98 and TA100 were treated with test material using the Ames plate incorporation method at six dose levels in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10 % liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay ranged between 0.15 to 150 µg/plate in the first experiment. The experiment was repeated on a separate day using a similar dose range to Experiment 1, fresh cultures of the bacterial strains fresh test material formulations.
Additional dose levels were included to allow for test material induced toxicity, ensuring that a minimum of four non-toxic dose levels were achieved.
The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, sensitivity of the assay and the efficacy of the S9-mix were validated.
The test material caused a visible reduction in the growth of the bacterial background lawn to all of the tester strains initially at 50 and 15 µg/plate, with and without S9-mix, respectively. The test material was, therefore, tested up to the toxic limit. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any the bacterial strains, with any dose of the test material, either with or without metabolic activation.
In conclusion the test material was considered to be non-mutagenic under the conditions this test.
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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