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Diss Factsheets
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EC number: 947-057-6 | 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
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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:
- 17 October 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted similarly to OECD 471 Guideline with deviations: purity of test substance; evaluation criteria not reported ; E. Coli strain not tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- purity of test substance; evaluation criteria not reported ; E. Coli strain not tested
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride
- EC Number:
- 274-033-6
- EC Name:
- 2-hydroxy-3-[(1-oxodocosyl)oxy]propyltrimethylammonium chloride
- Cas Number:
- 69537-38-8
- Molecular formula:
- C28H58NO3.Cl
- IUPAC Name:
- 3-(docosanoyloxy)-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Reference substance name:
- 2-methylpentane-2,4-diol
- EC Number:
- 203-489-0
- EC Name:
- 2-methylpentane-2,4-diol
- Cas Number:
- 107-41-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-methylpentane-2,4-diol
- Test material form:
- solid
- Remarks:
- white waxy solid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Date of receipt: 26 August 1980
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction was prepared from liver homogenates of male Wistar rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 0.06, 0.19, 0.56, 1.67 and 5.0 mg/ 0.1 ml H2O/ plate, with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water
- Appropriate solutions of the test material were prepared in glass distilled water immediately before use.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: hycanthone methanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM
- Salmonella typhimurium mutants used viz. S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were provided by Dr. B.N. Ames, Berkeley, California, USA.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 37 °C for 3 days
NUMBER OF REPLICATIONS:
3 plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was evaluated by background lawn of bacterial growth.
OTHER:
- Colonies (revertants which are histidine independent) were counted and the background lawn of bacterial growth was examined microscopically.
- S9, S9 mix and test product was checked for sterility. - Rationale for test conditions:
- The dose range used in the mutagenesis assay was based on a preliminary test performed to assess the toxicity of the compound for the bacteria.
- Evaluation criteria:
- No data
- Statistics:
- None
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The dose levels used in the study were based on the solubility of the test substance in water: 5 % (w/v) was soluble, while 10 % was not soluble.
CYTOTOXICITY:
There were no signs that chemical toxicity interfered with the mutagenicity testing; the background lawn of bacterial growth in control and test plates was comparable.
MUTAGENICITY
- Test substance up to 5 mg/plate did not increase the numbers of his+ revertants with any of the five tester strains, either in the presence or in the absence of S9 mix.
Any other information on results incl. tables
See "Attached background material" section for table of results
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, test substance is not considered as mutagenic in S. typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) strains.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed similarly to the OECD Guideline 471, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) were exposed to test substance at the following concentrations using plate incorporation method: 0.06, 0.19, 0.56, 1.67 and 5.0 mg/plate, with and without metabolic activation
S9 fraction prepared from liver homogenates of male Wistar rats induced with Aroclor 1254. Vehicle and positive control groups were also included in mutagenicity tests.
No evidence of toxicity was observed up to 5.0 mg/plate with or without metabolic activation and the background lawn of bacterial growth in control and test plates was comparable. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation.
Under the test conditions, test substance is not considered as mutagenic in this bacterial system.
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