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EC number: 210-513-3 | CAS number: 617-45-8
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to international accepted guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acid D,L-aspart
- EC Number:
- 210-513-3
- EC Name:
- Acid D,L-aspart
- Cas Number:
- 617-45-8
- Molecular formula:
- C4H7NO4
- IUPAC Name:
- aspartic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Test item D,L-aspartic acid
Alternative name D,L-aszparaginsav cfn. 100% Hat.
Batch No. S27170N
Physical state Solid
Loss on drying 13.5%
Active ingredient in dry substance 98.3%
Chloride ion 200 μg / g
Manufacturing date 20 July 2012
Expiry date 20 January 2014
Storage 15-30°C
Dose correction factor 1.176
Constituent 1
Method
- Target gene:
- In addition to histidine or tryptophan mutation, each strain has additional mutations which enhance its sensitivity to mutagens. The uvrB (uvrA) strains are defective in excision repair, making them more sensitive to the mutagenic and lethal effects of a wide variety of mutagens because they cannot repair DNA damages. The presence of rfa mutation increases the permeability of the bacterial lipopolysaccharide wall for larger molecules. The plasmid pKM101 (TA98, TA100) carries the muc+ gene which participates in the error-prone "SOS" DNA repair pathway induced by DNA damage. This plasmid also carries an ampicillin resistance transfer factor (R-factor) which is used to identify its presence in the cell. The Escherichia coli strain used in this test (WP2uvrA) is also defective in DNA excision repair.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Frozen stock cultures of all strains were prepared from the disc cultures immediately. The identification codes and expiry dates of the actual applied
stock cultures were the following:
Salmonella typhimurium TA98; 111005 Expiry date: 05 October 2013
Salmonella typhimurium TA100; 111005 Expiry date: 05 October 2013
Salmonella typhimurium TA1535; 111005 Expiry date: 05 October 2013
Salmonella typhimurium TA1537; 111005 Expiry date: 05 October 2013
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Frozen stock cultures of all strains were prepared from the disc cultures immediately. The identification codes and expiry dates of the actual applied
stock culture were the following:
Escherichia coli WP2 uvrA; 111005 Expiry date: 05 October 2013
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Justification of concentrations: Choice of the concentrations was done on the basis of a Solubility Test and a concentration Range Finding Test (Informatory Toxicity Test). The D,L-aspartic acid concentrations planned for the main experiments: 5000, 1581, 500, 158 and 50 μg/plate.
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide; Ultrapure water
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine; 2-aminoanthracene
Results and discussion
Test resultsopen allclose all
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- 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'.
Any other information on results incl. tables
Based on the solubility test, the stock solution with a concentration of 5 mg/mL was prepared in ultrapure water and diluted in 6 steps by factor of approximately √10. The revertant colony numbers and the inhibition of the background lawn of auxotrophic cells of two of the tester strains (Salmonella typhimurium TA98, TA100) were determined at the concentrations of 5000, 1581, 500, 158, 50, 15.8 and 5 μg/plate of the test item. The revertant colony numbers of vehicle control plates with and without S9 Mix were in line the corresponding historical control data ranges. The positive control treatments showed the expected, biological relevant increases in induced revertant colonies in both tester strains. In comparison with the revertant colony numbers of the vehicle control plates sporadic changes slightly lower or higher revertant colony counts were observed in both strains examined at the test item.
In comparison with the revertant colony numbers of the vehicle control plates sporadic changes, slightly higher revertant colony counts were observed in S. typhimurium TA98 in the concentration range of 5000-15.8 μg/plate, without metabolic activation (-S9 Mix), furthermore in TA100 at the concentration of 5000 μg/plate, with addition of metabolic activation (+S9 Mix). These obtained changes were considered as reflecting the biological variability of the applied test system. The observed revertant colony numbers remained in the vehicle control data range, however were below the corresponding historical control data range (without any biological significance) in S. typhimurium TA100, in the concentration range of 500-15.8 μg/plate, in absence (-S9 Mix) and at the concentration level of 5 μg/plate in presence of metabolic activation (+S9 Mix). The experimental results (revertant colony numbers per plate, mutation factors, standard deviations) are summarised in Table 8 (Appendix I) and in Tables 11-12 (Appendix II).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The reference mutagen treatments (positive controls) showed the expected, biological relevant increases in induced revertant colonies in all experimental phases, in all tester strains. The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. In conclusion, the test item D,L-aspartic acid has no mutagenic activity on the applied bacterium tester strains under the test conditions used in this study.
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