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EC number: 200-291-6 | CAS number: 56-84-8
- 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
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- Direct plate incorporation method.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Aspartic acid
- EC Number:
- 200-291-6
- EC Name:
- Aspartic acid
- Cas Number:
- 56-84-8
- Molecular formula:
- C4H7NO4
- IUPAC Name:
- aspartic acid
- Reference substance name:
- L-Asparaginsäure
- IUPAC Name:
- L-Asparaginsäure
- Reference substance name:
- S-(+) amino succinic acid
- IUPAC Name:
- S-(+) amino succinic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Supplier: Sponsor.
Batch No.: PRCA 015.
CAS No. 56-84-8.
Appearance: White, crystalline.
Purity: Approx. 99 %.
pH: 2.5 – 3.5 (4 g/L at 20 °C).
Melting range: 265 – 271 °C.
Solubility in water: 5 g/L at 25°C.
Conditions of storage: In the refrigerator, in the dark, may be used under light.
Date of expiry: 31 December 2002.
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- Microsomal fraction of rat liver, induced with Aroclor 1254.
- Test concentrations with justification for top dose:
- 62 to 5000 µg/plate.
- Vehicle / solvent:
- - Vehicle/solvent used: water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene; 1,8-dihydroxy-anthraquinone; 4-nitro-o-phenylenediamine; t-butyl-hydroperoxide
- Details on test system and experimental conditions:
- Preliminary toxicity test: Different concentrations of test substance solutions were mixed with phosphate buffer, bacteria (TA100) and top-agar, and spread over a plate with minimal agar. The plates were incubated at 37 °C for 2 days and the growth of the bacterial background and the density of revertant colonies was determined.
The test substance was tested without as well as with an external metabolising system (S9-mix). The results were verified by a second, independent experiment.
The exposure was performed according to the 'Plate Incorporation Assay', in which bacteria, test substance (and microsomes) are in contact on the plate without preceding incubation in the liquid state. The number of viable cells in the overnight-cultures is in the range of 2 x 108 cells per mL. - Evaluation criteria:
- The plates with less than about 50 revertant colonies, i.e. the plates of TA98 and TA1535 with the exception of the positive controls, were counted visually by marking the colonies with a felt tipped pen. The other plates were photographed with a video camera and the picture files were scanned for colonies by a computer program.
The criteria for a positive result are:
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:
• For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: The 2.5 fold of the amount of the spontaneous revertants.
• For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: The 1.67 fold of the amount of the spontaneous revertants. - Statistics:
- Means and standard deviation were calculated for the number of mutants in every concentration group.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test substance was not toxic up to 5000 µg/petri dish.
A precipitate was visible when the test substance was mixed with the agar at the 5000 µg/plate samples.
In the preliminary test and in the main test no toxicity was seen up to 5000 µg/plate.
There was no increase in the number of mutants in any of the tested bacterial strains at any of the tested concentrations. The addition of an external metabolising system did not change these results.
For details see the attachment. - 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
L-aspartic acid did not induce mutagenicity either with or without metabolic activation in any of the bacterial strains at any level evaluated with the plate incorporation method at dose levels up to 5000 µg/plate. - Executive summary:
L-Aspartic acid was tested for mutagenic activity with the "Salmonella typhimurium Reverse Mutation Test" (Ames Test). The study was conducted in accordance with the OECD-guideline 471 and directive 2000/32/EC, part 8.13/14.
The test substance, dissolved in water, was tested at concentrations ranging from 62 to 5000 µg per plate according to the "direct plate incorporation method" without external metabolisation as well as with an external metabolising system (S9-mix). As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. An independent repetition of the experiment was performed.
All positive control groups showed significantly increased mutation frequencies which demonstrate the sensitivity of the test system. No toxicity of the test substance to the bacteria was observed up to 5000 µg per plate.
At the 5000 µg/plate samples a precipitate was visible when the test substance was mixed with the agar.
L-aspartic acid did not induce mutagenicity either with or without metabolic activation in any of the bacterial strains at any level evaluated with the plate incorporation method at dose levels up to 5000 µg/plate.
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