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EC number: - | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Ames test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 18 April, 1989 to 08 May, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- S. Typhimurium TA102 and/or E.coli WP2 strains not included; conducted according to old version of Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- the version of the OECD guideline should be specified: OECD 471 (1983).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- EC Number:
- 263-038-9
- EC Name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- Cas Number:
- 61789-18-2
- Molecular formula:
- C(n+3) H(2n+10) N Cl (n=8-18)
- IUPAC Name:
- Quaternary ammonium compounds, cocoalkyl trimethyl, chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Batch: 01263LA
- Description: Clear, colourless liquid, contained in a glass screw-capped bottle. It was stored at room temperature and protected from light until required. The test substance was identified as a 33% aqueous solution.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 1, 3, 10, 32 and 100 µg/plate for both with and without S9-mix
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Tested with TA 1535, TA 100 in the absence of S-9 mix
- Untreated negative controls:
- yes
- Remarks:
- Solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Tested for TA 1535 in the presence and absence of S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Tested for TA 1537 in the absence of S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Tested for TA 98 in the absence of S9-mix
- Untreated negative controls:
- yes
- Remarks:
- Solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Tested for TA 1537, TA 100 and TA 98 in the presence and absence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (pour-plate method)
DURATION
- Incubation period: 48 h at approximately 37°C
NUMBER OF REPLICATIONS: Three
DETERMINATION OF CYTOTOXICITY
- Method: Number of revertant colonies were counted, either manually or with a Biotran II automatic colony counter. Total colonies on nutrient plates were counted in the same way. Growth of the background lawn of non-revertant cells on minimal plates were verified. - Evaluation criteria:
- The number of the revertants per plate of the tester strain is compared to the control.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary toxicity test: Yes
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance is not considered to be mutagenic in the presence and absence of exogenous metabolic activation.
- Executive summary:
A study was conducted to determine the mutagenic potential of test substance, Coco TMAC (active ingredient 33%), according to OECD 471 and EPA OPPTS 870.5265 Guidelines, in compliance with GLP. Using pour-plate assays, the test substance was examined for mutagenic activity in four strains of Salmonella typhimurium: TA 100, TA 1535, TA 1537 and TA 98 in the absence and in the presence of S9-mix. The test concentrations included 0, 1, 3, 10, 32 and 100 µg/plate (i.e., equivalent to 0, 0.33, 0.99, 3.3, 10.56 and 33 µg/plate). No increase in reversion to prototrophy was obtained with any of the bacterial strain at any concentration level either in the presence or absence of S9-mix. Further, inhibition of growth, observed as thinning of the background lawn of non-revertant cells, occurred in all strains following exposure to the test substance at 100 µg/plate.Appropriate positive control chemicals (with S-9 mix where required) induced marked increases in revertant colony numbers with all strains, confirming sensitivity of the cultures and activity of the S-9 mix. Under the test conditions, the test substance was not mutagenic with and without metabolic activation (May, 1989).
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