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EC number: 606-203-6 | CAS number: 1902-01-8
- 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
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The Ames II Assay is a liquid version of the classical Ames test. It is performed in microwell plates using a modified fluctuation test protocil. Beside the traditional tester strain TA 98, a set of 6 his- mutant strains TA 7001- TA 7006 (Ames II tester strains was developed) The principle of the assa is that mutations are detected by the reversion of mutations present in the amino acid requiring bacterial strains. This leads to a restoration of the functional capability of the bacteria to synthesize the essential amino acid and thus the ability to grow in the absence of the amino acid required by the parent strains. In the Ames II assay this growth leads to an accumulation of catabolites from the metabolic activity of revertants dropping down the pH and, thus, turning the purple Ames II reversion indicator medium yellow.
- GLP compliance:
- no
- Remarks:
- but partially compliant
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- sodium (2R)-2,4-dihydroxy-3,3-dimethyl-butanoate
- Cas Number:
- 60979-68-2
- Molecular formula:
- C6 H11 Na O4
- IUPAC Name:
- sodium (2R)-2,4-dihydroxy-3,3-dimethyl-butanoate
- Details on test material:
- - Name of test material (as cited in study report): Natriumpantoat roh, ber. 100%
- Physical state: yellowish liquid
- Composition of test material, percentage of components: 20% main component, 65% water, 14% NaCl
- Lot/batch No.: B 671 Mischprobe
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- His
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ames II exposure medium and Ames II reversion indicator medium
- Properly maintained: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000, 5000, 10000 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: good solubility of the test material
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- - S9
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- - S9
- Positive control substance:
- other: 2-amino anthracene
- Remarks:
- + S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 90 minutes
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent): 48 hours
SELECTION AGENT (mutation assays): histidine
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
relative total growth and clearing or diminution of the backround lawn leading from trubid to non-turbid purple wells.
OTHER: - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met :
• A dose-related increase in the number of positive wells by a factor of about 2 (calculated primarily on the basis of baseline data) in at least one tester strain either without S-9 mix or after adding a metabolizing system .
A test substance is generally considered non-mutagenic in this test if :
• The number of revertant wells for all tester strains were within the historical negative control range under all experimental conditions .
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 98, TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance did not lead to an increase in the number of revertant wells either without S-9 mix or after adding a metabolizing system.
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