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EC number: 225-896-2 | CAS number: 5137-55-3
- 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 transformation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Gene mutation toxicity study of the test chemical
- Author:
- Inoue et al
- Year:
- 1 980
- Bibliographic source:
- Food and chemical toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vitro mammalian cell transformation assay was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cetalkonium chloride
- EC Number:
- 204-526-3
- EC Name:
- Cetalkonium chloride
- Cas Number:
- 122-18-9
- Molecular formula:
- C25H46NCl
- IUPAC Name:
- Cetyldimethylbenzylammonium chloride
- Details on test material:
- - Name of test material: cetyldimethylbenzylammonium chloride (CDBAC)
- IUPAC name: Benzylcetyldimethylammonium Chloride Hydrate
- Molecular formula: C25H46NCl
- Molecular weight: 396.098 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 98.4%
- Impurities (identity and concentrations): 1.6%
Constituent 1
Method
- Target gene:
- No data
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: In vitro mammalian cell transformation assay
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The standard complete culture medium used was Dulbecco’s modified Eagle medium supplemented with 2 mM+glutamine and 20% foetal bovine serum without any antibiotics. For dissociation of embryos and preparation of subcultures, 0.25% trypsin solution was used; i.e. 10 ml trypsin- EDTA solution (10 x) and 90 ml Ca2+- and Mg 2+-free solution (PBS).
- Properly maintained: No data
- Periodically checked for Mycoplasma contamination: No data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: No data - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- not specified
- Metabolic activation system:
- No data
- Test concentrations with justification for top dose:
- - Type and identity of media: The standard complete culture medium used was Dulbecco’s modified Eagle medium supplemented with 2 mM+glutamine and 20% foetal bovine serum without any antibiotics. For dissociation of embryos and preparation of subcultures, 0.25% trypsin solution was used; i.e. 10 ml trypsin- EDTA solution (10 x) and 90 ml Ca2+- and Mg 2+-free solution (PBS).
- Properly maintained: No data
- Periodically checked for Mycoplasma contamination: No data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: No data - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- Medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 3-methylcholanthrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 20 mins
- Exposure duration: 9 days
- Expression time (cells in growth medium): 9 days
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): 10 mins
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): Giemsa stain
NUMBER OF REPLICATIONS: Nine dishes were used for each dose level in all the experiments (in a few cases only eight or seven dishes were used for controls).
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- Criteria for transformation: Randomly oriented three-dimensional growth with extensive crossing over of the cells at the periphery of the colony was considered to be the endpoint of morphological transformation. The centres of transformed colonies usually exhibit dense piling-up of cells. Moreover, these cells usually have an increased ratio of nucleus to cytoplasm, are more basophilic, and are variable in size.
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: Pregnant Syrian golden hamsters embryo cell line
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No data
Any other information on results incl. tables
Table 1. In vitro cell transformation of the test compound and the respective control chemicals
Compound |
No. of transformed colonies/No. of surviving colonies |
|||||||||||||||
0.2% DMSO |
3MC (µg/mL) |
Dose of the test chemical (µg/mL) |
||||||||||||||
0.1 |
0.5 |
1.0 |
0 |
0.01 |
0.05 |
0.1. |
0.5 |
1 |
5 |
10 |
20 |
50 |
100 |
300 |
||
Test chemical |
0/603 |
0/538 |
1/527 |
0/500 |
0/620 |
0/583 |
0/606 |
0/576 |
0/496 |
- |
- |
- |
- |
- |
- |
- |
DMSO = Dimethylsulphoxide
MC = 3-Methylcholanthrene
Applicant's summary and conclusion
- Conclusions:
- The test chemical did not induce cell transformation in the Pregnant Syrian golden hamsters embryo cell line used and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
In vitro mammalian cell transformation assay was performed to determine the mutagenic nature of the test chemical. The test chemical was dissolved in DMSO as the solvent and used at dose level of 0, 0.01, 0.05, 0.1, 0.5, 1, 5, 10, 20, 50, 100 or 300µg/mL. Pregnant Syrian golden hamsters were killed on days 13 and 14 of gestation for preparation of target cells and feeder-layer cells respectively. Embryos without heads and viscera were minced with scissors,a nd trypsinized with 0.25% trypsin. Inocula of 10000000 embryo cells per 75-cm’ flask were incubated at 37°C in a humidified atmosphere of 10% CO2 in air. When they became confluent primary cultures were trypsinized, dispensed in lots of 5000000 cells in glass ampules, and stored in liquid nitrogen for use as target and feeder-layer cells. The assay takes 15 days from start to finish. On Day 0, an ampule of cryopreserved primary cells prepared as feeder-layer cells was rapidly thawed and plated in a 75-cm2 flask containing 20 ml of the culture medium. The medium was changed every day. On day 3, an ampule of cryopreserved primary cells prepared as target cells was also rapidly thawed and plated in a 75-cm2 flask. On day 4, the feeder cells which were shifting from a stage of logarithmic growth to a stationary phase were irradiated with 5000 R from a linear accelerator, trypsinized, and then plated at 6 x lo4 tells/60-mm dish in 2 ml of complete medium. On day 5, the target cells which were approximately 80 -90% confluent were trypsinized, and a suspension of 500 target cells in 2 ml of complete medium was then added to each of the dishes plated the day before with irradiated feeder-layer cells. On day 6, an appropriate dose of the test chemical in a volume of 4 ml was added, giving a total volume of 8 ml of medium in each dish. Nine dishes were used for each dose level in all the experiments (in a few cases only eight or seven dishes were used for controls). On day 14, the cultures werefixed with absolute methanol for 10min and stained with Giemsa solution for 45 min or more. The stained dishes were examined with a stereoscopic dissection microscope to count normal and transformed colonies. The exposure duration was 8 days. Concurrent solvent and negative control chemicals were also included in the study. The test chemical did not induce cell transformation in the Pregnant Syrian golden hamsters embryo cell line used and hence it is not likely to classify as a gene mutant in vitro.
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