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Diss Factsheets
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EC number: 692-713-4 | CAS number: 886588-62-1
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study is well documented but not according GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- R97-0491 Ames BN, McCann J, Yamasaki E. Methods for detecting carcinogens and
mutagens with the salmonella/mammalian-microsome mutagenicity test.
Mutat Res 1975; 31:347-364.
R99-2379 Gee P, Sommers CH, Melick AS, Gidrol XM, Todd MD, Burris RB, et al.
Comparison of responses of base-specific Salmonella tester strains with the
traditional strains for identifying mutagens: the results of a validation study.
Mutat Res 1998; 412:115-130.
R04-0638 Flueckiger-Isler S, Baumeister M, Braun K, Gervais V, Hasler-Nguyen N,
Reimann R, et al. Assessment of the performance of the Ames II assay: a
collaborative study with 19 coded compounds. Mutat Res Genet Toxicol
Environ Mutagen 2004; 558:181-197. - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (3R)-3-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)piperidin-1-ium (2S,3S)-3-carboxy-2,3-dihydroxypropanoate
- EC Number:
- 692-713-4
- Cas Number:
- 886588-62-1
- Molecular formula:
- C13 H14 N2 O2 . C4 H6 O6
- IUPAC Name:
- (3R)-3-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)piperidin-1-ium (2S,3S)-3-carboxy-2,3-dihydroxypropanoate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006 and TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- CD 713 TD was dissolved in dimethylsulfoxide DMSO (negative control). The highest test concentration 5000 μg/mL was not soluble in DMSO.
Therefore, 7 concentration levels from 1 to 2500 μg/mL were tested along with the appropriate negative and positive controls.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- other: 2-aminoanthracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no bacteriotoxicity up to the highest soluble concentration of 2500 μg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- Interpretation of results (migrated information):
negative
Based on the described results it is concluded, that CD 713 TD, when tested up to insoluble concentrations, caused neither base-pair substitutions
nor frameshift mutations in bacteria. No evidence of genotoxic activity was observed in a series of S. typhimurium tester strains (TA Mix and TA 98)
in the absence and presence of metabolic activation. The test article is, therefore, classified as "Ames II negative". - Executive summary:
The Ames II assay is a high throughput version showing a high correlation with the traditional Salmonella assay. Concurrently with positive and negative (vehicle) controls, the test article was tested over a concentration range from 1 to 2500 μg/mL medium with and without microsomal rat liver enzymes (Aroclor 1254-induced). The bacterial tester strains S. typhimurium TA Mix (TA 7001, TA 7002, TA 7003, TA 7004, TA 7005 and TA 7006, sensitive to base-pair substitution) and TA 98 (susceptible to frameshift mutagens) are histidine-auxotrophic and were exposed with the test substance for 90 minutes. Using the liquid fluctuation technique revertant growth was quantified colorimetrically in 384-well plates after 48 hours at 37°C.
Solubility and Toxicity
CD 713 TD showed neither precipitation nor bacteriotoxicity up to the highest soluble concentration of 2500 μg/mL. The highest planned test concentration of 5000 μg/mL was not soluble in DMSO.
Mutagenicity
CD 713 TD did not increase consistently the number of positive wells in the different tester strains with and without S9 mix as compared to the vehicle control. The negative control showed a mean number of positive wells for S. typhimurium TA Mix (TA 7001- 7006) and TA 98 similar to those described in the literature (≤8/48 wells).
Based on the described results it is concluded, that CD 713 TD, when tested up to insoluble concentrations, caused neither base-pair substitutions nor frameshift mutations in bacteria. No evidence of genotoxic activity was observed in a series of S. typhimurium tester strains (TA Mix and TA 98) in the absence and presence of metabolic activation. The test article is, therefore, classified as "Ames II negative".
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