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EC number: 931-291-0 | 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:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1991 - May 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted equivalent to OECD Guideline 471 and according to GLP, but the study was not conducted with E.coli and/or with S. typhimurium TA102, which have an AT base pair at the primary reversion site.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- not conducted with E.coli and/or with S. typhimurium TA102
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Molecular formula:
- For two representative potential structures: C20H36N2O6Na2 : 446 and C18H35N2O4Na: 367
- IUPAC Name:
- Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- Sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- other: Aqueous solution
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Based on the dose finding preliminary toxicity test, the doses in the main test were chosen as 1.3, 6.4, 32, 160 and 800 µg/plate (related to active
component of the test article). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: Water is regarded as compatible with the Ames test. The minimum required solubility for the test article of 5% (corresponding with 5000 μg/plate) was reached.
Controls
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: Na-azide for TA100 and TA1535; 9-Aminoacridinehydrochloride monohydrate for TA1537 and 4-nitro-1,2-phenylene diamine for TA98. Metabolic activation by S9-mix was checked with 2-aminoanthracene for all strains.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
DETERMINATION OF CYTOTOXICITY
- Method: the number of colonies, the number of revertants and the background growth - Evaluation criteria:
- After an incubation for 48 hours at 37 degrees Celsius the colonies were counted by Artek Counter Model 982B. The validity of the automatic counts is secured by manual control counting at regular time intervals. The following criteria were used for the acceptance:
-The negative controls have to be within the the expected range as defined by literature data (Maron and Ames 1983)
-The positive controls have to show sufficient effects as defined by the laboratory's experience
-The titer determination must yield a sufficient bacterial density in the suspension - Statistics:
- Not applicable
Results and discussion
Test results
- 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Not reported
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Negative at up to cytotoxic concentration (800 µg/plate) with and without metabolic activation in the Salmonella typhimurium reverse mutation assay.This study was not conducted with E.coli and/or S. typhimurium TA102, thus not detecting certain oxidising mutagens, cross-linking agents and hydrazines.
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