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EC number: 200-811-1 | CAS number: 74-79-3
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-07-27 to 2006-02-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
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:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Arginine
- EC Number:
- 200-811-1
- EC Name:
- Arginine
- Cas Number:
- 74-79-3
- Molecular formula:
- C6H14N4O2
- IUPAC Name:
- arginine
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: Human
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 0 mg/l, 6.8 µg/l, 13.59 µg/l, 27.19 µg/l, 54.38µg/l, 108.75 µg/l, 217.5 µg/l, 435 µg/l, 870 µg/l, 1740 µg/l.
Experiments 1 and 3: 435 µg/l, 870 µg/l, 1740 µg/l. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tissue culture medium = Eagle's minimal essential medium with HEPES buffer (MEM).
- Justification for choice of solvent/vehicle: Sustains activity of testing cells
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Absence of S9-mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Presence of S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION AND OTHER CULTURE CONDITIONS
1. With metabolic activation (S9) treatment:
After 48 h the cultures were transferred to tubes and centrifugated. Approximately 9 ml of the culture medium was removed, reserved, and replaced with the required volume of MEM (including serum) and 1.0 ml of the appropriate solution of vehicle control or test material was added to each culture. For the positive
control, 0.1 ml of the appropriate solution was added to the cultures. 1 ml of 20% S9-mix (ie 2% final concentration of S9 in standard co-factors) was added to the cultures of the preliminary toxicity Test and of experiment 1.
In Experiment 2, 1 ml of 10% S9-mix (ie 1% final concentration of S9 in standard co-factors), was added. All cultures were then returned to the incubator. The nominal final volume of each culture was 10 ml.
After 4 hours, the cultures were centrifuged, the treatment medium removed by suction and replaced with an 8 ml wash of MEM culture medium. After a further centrifugation the wash medium was removed by suction and replaced with the original culture medium. The cells were then re-incubated for a further 20 hours at 37°C.
2. Without metabolic activation (S9) treatment:
In Experiment 1, after approximately 48 hours incubation the cultures were decanted into tubes and centrifuged. Approximately 9 ml of the culture medium
was removed and reserved. The cells were then resuspended in the required volume of fresh MEM (including serum) and dosed with 1.0 ml of the appropriate vehicle control, test material solution or 0.1 ml of positive control solution. The total volume for each culture was a nominal 10 ml.
After 4 hours, the cultures were centrifuged the treatment medium was removed by suction and replaced with an 8 ml wash of MEM culture medium. After a further centrifugation the wash medium was removed by suction and replaced with the reserved original culture . medium. The cells were then returned to the incubator for a further 20 hours.
In Experiment 2 the exposure was continuous for 24 hours. Therefore, when the cultures were established the culture volume was a nominal 9.0 ml. After approximately 48 hours incubation the cultures were removed from the incubator and dosed with 1.0 ml of vehicle control, test material dose solution or 0.1 ml positive control solution. The nominal final volume of each culture was 1 0 ml. The cultures were then incubated for 24 hours.
SPINDLE INHIBITOR (cytogenetic assays): Demecolcine (clocemid 0.1 µg/l).
STAIN (for cytogenetic assays): 5 % Gurrs Giemsa for 5 minutes.
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: The following numbers apply for experiments 1 and 2 and are per replicate.
Vehicle control, test material, with and without metabolic activation, positive control with metabolic activation: 100
Positive control without metabolic activation: 50 (slide evaluation terminated at 50 cells because approximately 50 % cells with aberrations had been observed.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- A positive response was recorded for a particular treatment if the % cells with aberrations, excluding gaps, markedly exceeded that seen in the concurrent control, either with or without a clear dose-relationship. For modest increases in aberration frequency a dose response relationship is generally required and appropriate statistical tests may be applied in order to record a positive response.
- Statistics:
- The frequency of cells with aberrations excluding gaps and the frequency of polyploid cells was compared, where necessary, with the concurrent vehicle control value using Fisher's Exact test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- 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:
- RANGE-FINDING/SCREENING STUDIES: Yes: preliminary toxicity test
COMPARISON WITH HISTORICAL CONTROL DATA: Yes. - 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
In a GLP guideline study according to OECD 473 L-arginine did not induce a statistically significant increase in the frequency of cells with chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in either of two separate experiments. The maximum test concentration was 1740 µg/l. The test material was therefore considered to be non-clastogenic to human lymphocytes in vitro.
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