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Diss Factsheets
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EC number: 200-293-7 | CAS number: 56-86-0
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 30 - December 01, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Based on structural similarity, common metabolic pathway, environmental fate, comparable physico-chemical and (eco)toxicological properties, it is considered justified to use this study also for this substance. See the attached background document for detailed information. This study has been performed according to OECD and/or EC guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Designation of Food Additives and for Revision of Standards for Use of Food Additives" (Japanese Ministry of Health and Welfare, Eika No. 29, March 22, 1996)
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline for Genotoxicity Tests on Drugs" (Pharmaceutical and Medical Safety Bureau, Japanese Ministry of Health and Welfare, Notification Iyakushin No. 1604, November 1, 1999)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Principles of method if other than guideline:
- US Food and Drug Administration Redbook 2000: Toxicological Principles for the Safety Assessment of Food Ingredients IV.C.1.b. In vitro Mammalian Chromosomal Aberration Test" (July 7, 2000). The study conduct also complied with OECD 473.
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Sodium hydrogen glutamate
- EC Number:
- 205-538-1
- EC Name:
- Sodium hydrogen glutamate
- Cas Number:
- 142-47-2
- Molecular formula:
- C5H8NNaO4
- IUPAC Name:
- Sodium 2-amino-4-carboxybutanoate
- Reference substance name:
- 6106-04-3
- Cas Number:
- 6106-04-3
- IUPAC Name:
- 6106-04-3
- Details on test material:
- - Name of test material (as cited in study report): Monosodium L-glutamate monohydrate produced by a new method
- Substance type: hydrated form
- Physical state: White powder
- Stability under test conditions: stable
- Storage condition of test material: At room temperature under shading from light and well-closed conditions
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Chinese Hamster Lung (CHL/IU)
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and 5,6-benzoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Dose range finding/Growth inhibition test: without S9 mix: 0.030, 0.059, 0.12, 0.24, 0.48, 0.95 and 1.9 mg/ml (6h and 24h exposure; 24h fixation)
Dose range finding/Growth inhibition test: with S9 mix: 0.030, 0.059, 0.12, 0.24, 0.48, 0.95 and 1.9 mg/ml (6h exposure; 24h fixation)
Cytogenetic test: with and without S9 mix: 0.24, 0.48, 0.95 and 1.9 mg/ml (6h and 24 h exposure; 24h fixation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injection lP
- Justification for choice of solvent/vehicle: the test article was easily soluble in water (solubility: 740 mg/mL, 25°C).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water for injection lP
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
Migrated to IUCLID6: in distilled water for injection JP
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix
Migrated to IUCLID6: in distilled water for injection JP
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 72h
- Exposure duration: 6h (with and without S9 mix), 24h (without S9 mix)
- Fixation time (start of exposure up to fixation or harvest of cells): 24h
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa solutions diluted with phosphate buffer
NUMBER OF REPLICATIONS: four in each group, duplicate in the positive control group
NUMBER OF CELLS EVALUATED: 200 metaphase chromosome spreads per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index of each culture was determined by counting the number of metaphases per 500
cells.
- Determination of polyploidy: yes
- Determination of endoreplication: no - Evaluation criteria:
- Clastogenicity and polyploid induction of the test article were judged by considering the statistical analysis and biological significance.
- Statistics:
- The number of cells with structural chromosomal aberrations (excluding gaps) and polyploid cells in the treatment groups or the positive control
groups were statistically compared with the negative control group using Fisher's exact probability test (one-side, p<0.01). On the test systems in
which statistical significance was obtained, a dose-dependency of the induction of chromosomal aberrations was evaluated using the Cochran-
Armitage trend test (one-side, p<0.01).
Results and discussion
Test results
- Species / strain:
- mammalian cell line, other: Chinese Hamster Lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed at the beginning and end of the treatment in the medium by the naked eye under any treatment
condition.
RANGE-FINDING/SCREENING STUDIES: No effects observed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The results obtained with the substance Monosodium glutamate are suitable for the regulatory purpose of REACH for the substance L-Glutamic acid:
There was no statistical significance of cells with structural chromosomal aberrations and polyploid cells at any treatment group.
Positive controls, MMC in the short-term without S9 mix and the continuous treatment and CP in the short-term treatment with S9 mix, significantly
induced structural chromosomal aberrations. It was therefore judged that this study adequately estimated the clastogenic potential of the test article.
Accordingly, it was concluded that Monosodium L-glutamate monohydrate produced by a new method did not induce chromosomal aberrations in
CHL/IU cells under the present test conditions.
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