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EC number: 306-238-4 | CAS number: 96690-44-7
- 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
- Study period:
- From 05 December, 2002 to 13 January, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- 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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Quaternary ammonium compounds, C12-14 (even-numbered)-alkylethyldimethyl, ethyl sulphates
- EC Number:
- 939-607-9
- Molecular formula:
- C18 H41 N1 O4 S1
- IUPAC Name:
- Quaternary ammonium compounds, C12-14 (even-numbered)-alkylethyldimethyl, ethyl sulphates
- Test material form:
- other: solid
Constituent 1
- Specific details on test material used for the study:
- - Physical state: whitish pieces
- Lot/batch No.: LC0780
- Storage conditions: at room temperature
- Date of manufacture: 27, September, 2002
- Date of analysis: 27, September, 2002
- Date of receipt: 27, November, 2002
- Description: Refer to appendex 1 of the attached report for more details (page 22)
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other:
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (purchased from Moltox (Molecular Toxicology, INC, Boone, NC 28607, USA) and obtained from the liver of rats treated with Aroclor 1254 (500 mg/kg) by the intraperitoneal route. The S9 fraction was preserved in sterile tubes at -80°C, until use)
- Test concentrations with justification for top dose:
- Preliminary test concentrations:10, 100, 500, 1000, 2500 and 5000 μg/plate for both with and without S9-mix
Main test concentrations: Experiments without S9 mix:
• 1.23, 3.7, 11.1, 33.3 and 100 μg/plate, for all tester strains in the first experiment,
• 0.41, 1.23, 3.7, 11.1 and 33.3 μg/plate, for all tester strains in the second experiment.
Experiments with S9 mix:
• 1.23, 3.7, 11.1, 33.3 and 100 μg/plate, for all tester strains in the first experiment,
• 3.7, 11.1, 33.3, 100 and 200 μg/plate, for all tester strains in the second experiment, except for the TA 1537 strain,
• 1.23, 3.7, 11.1, 33.3 and 100 μg/plate, for the TA 1537 strain in the second experiment. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide (DMSO), batch No. K30379650 214 (Merck Eurolab, Fontenay-Sous-Bois, France).
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:
- 1 μg/plate: for TA 1535 and 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:
- 9-aminoacridine
- Remarks:
- 50 μg/plate: for TA 1537 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:
- 2-nitrofluorene
- Remarks:
- 0.5 μg/plate: for TA 98 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:
- mitomycin C
- Remarks:
- 0.5 μg/plate: for TA 102 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:
- benzo(a)pyrene
- other: 2-anthramine
- Remarks:
- 2 μg/plate: for TA 1535, TA1537, TA 98 and TA 100 in the presence of S9 mix and 10 μg/plate: TA 102 in the presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation method) as well as preincubation method
DURATION
- Incubation period: 48 to 72 h at approximately 37°C
NUMBER OF REPLICATIONS: Three/dose
DETERMINATION OF CYTOTOXICITY
- Method: Number of revertant colonies were counted, with an automatic counter (Artek counter, model 880, OSi, 75015 Paris, France or cardinal counter, Perceptive instruments, Suffolk CB9 7 BN, UK) - Evaluation criteria:
- - Treatment of results
In each experiment, for each strain and for each experimental point, the number of revertants per plate was scored. The individual results and the mean number of revertants, with the corresponding standard deviation and ratio (mutants obtained in the presence of the test item/mutants obtained in the presence of the vehicle), are presented in tabular form.
- Acceptance criteria
This study is considered valid if the following criteria are fully met:
• the number of revertants in the vehicle controls is consistent with the historical data of the testing facility (appendix 1),
• the number of revertants in the positive controls is higher than that of the vehicle controls and is consistent with the historical data of the testing facility.
- Evaluation criteria
A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
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
- Remarks:
- A moderate to strong toxicity was noted in all tester strains mainly at concentration-levels ≥ 33.3 μg/plate (experiments without S9). A moderate to strong toxicity was noted in all tester strains mainly at concentration-levels ≥ 100 μg/plate (with S9).
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary toxicity test: Yes
Any other information on results incl. tables
Refer to the attached report (pages 15 to 19) for full details
Applicant's summary and conclusion
- Conclusions:
- Under the study 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 the test substance according to OECD 471 Guideline and EU Method B.13/14, in compliance with GLP. The test substance was examined for mutagenic activity in five strains of Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102, using the plate incorporation and pre-incubation methods. The studies were performed in the absence and presence of metabolic activation (S9-mix). The concentrations ranged from 1.23 to 100 µg/plate in first experiment and 0.41 to 200 µg/plate in second experiment. No increase in reversion to prototrophy was obtained with any of the bacterial strain at any concentration 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. Under the study conditions, the test substance was not considered to be mutagenic in the presence and absence of exogenous metabolic activation (Haddouck, 2003).
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