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EC number: 221-678-6 | CAS number: 3184-13-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines for Genotoxicity Studies of Drugs and the Standards for Mutagenicity Tests Using Microorganisms
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- L-(+)-2,5-diaminopentanoic acid
- EC Number:
- 221-678-6
- EC Name:
- L-(+)-2,5-diaminopentanoic acid
- Cas Number:
- 3184-13-2
- Molecular formula:
- C5H12N2O2.ClH
- IUPAC Name:
- L-(+)-2,5-diaminopentanoic acid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Bio Co., Ltd. Batches 080926 and 083019
- Expiration date of the lot/batch: practically stable
- Purity test date: 1993-08-27
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble
-
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
Purity >/= 99.9 %
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Preliminary test: 13, 26, 53, 105, 211, 422, 843, or 1686 µg/mL
Justification: Guidelines
Short-term exposure experiments: 422, 843, or 1686 µg/mL.
Justification: 1686 µg/mLnegative in preliminary test.
Continuous experiments: 422, 843, and 1686 µg/mL
Justification: 1686 µg/mLnegative in preliminary test. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: physiological saline
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- A preliminary cell growth inhibition test was conducted in order to select the concentrations of L-ornithine monohydrochloride to be used in the chromosome aberration test. In accordance with the Japanese Ministry of Labor guidelines, the top dose tested in the range finding assay was 0.01 M (equivalent to 1686 µg/mL). Briefly, 2 x 10exp4 cells were seeded into a 60 mm culture dish and incubated for 3 days. The test article was applied to the culture medium at concentrations of 0 (solvent control) 13, 26, 53, 105, 211, 422, 843, or 1686 µg/mL and cells were incubated for either 24 or 48 h at 37 °C. The procedure was repeated with the addition of S9 mix. Cell growth inhibition rate was measured as a percentage of cells in the solvent control.
In the short-term exposure experiments, L-ornithine was dissolved in physiological saline and added to the culture media at final concentrations of 422, 843, or 1686 µg/mL, in the presence or absence of exogenous metabolic activation (S9 mix). Untreated cultures and cultures incubated with saline were used as the negative controls, and 0.10 µg/mL mitomycin C (absence of exogenous metabolic activation) or 7.0 lg/mL benzo[a]pyrene (presence of exogenous metabolic activation) were used as positive controls. Cells were incubated with the solution containing the test article or controls for 6 h at 37 °C, followed by a rinse and further incubation in untreated culture media for an additional 18 h at 37 °C (recovery period). Colcemid (0.2 µg/mL) was added to the dishes 2 h before the end of the recovery period.
In the continuous experiments, cells were incubated with the solution containing the test article at final concentrations of 422, 843, and 1686 µg/mL for 24 or 48 h in the absence of metabolic activation. Untreated cultures and cultures incubated with saline were used as negative controls, and 0.05 µg/mL of mitomycin C was used as a positive control. Colcemid (0.2 µg/mL) was added to the dishes 2 h prior to the end of the treatment period. All cultures were prepared in duplicate. - Evaluation criteria:
- The frequency of chromosome aberrations or polyploidy did not exceed 5% at any of the concentrations of L-ornithine monohydrochloride tested, in either the short-term or continuous experiments. The frequency of chromosome aberrations in cells treated with mitomycin C or benzo[a]pyrene were consistent with historical positive control data.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the experiment, it was concluded that L-(+)-2,5-diaminopentanoic acid did not induce chromosome aberrations or polyploidy.
- Executive summary:
L-(+)-2,5-diaminopentanoic acid was tested for genetic toxicity in an in vitro cytogenicity study in mammalian cells.
No evidence of genotoxicity was observed in the chromosome aberration test at doses of up to 1686 mg/mL, both in the presence and absence of metabolic activation.
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