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Diss Factsheets
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EC number: 430-900-2 | CAS number: 192725-50-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- April 5 - August 17, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Done under GLP and OECD Methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Corning Hazleton protocol 449PCO, edition 1, modified for Abbott Labs
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 430-900-2
- EC Name:
- -
- Cas Number:
- 192725-50-1
- Molecular formula:
- Hill formula: C9H16N2O3 CAS formula: C9H16N2O3
- IUPAC Name:
- 3-methyl-2-(2-oxo-1,3-diazinan-1-yl)butanoic acid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Human lymphocytes
- Details on mammalian cell type (if applicable):
- Human venous blood
- Metabolic activation:
- with and without
- Metabolic activation system:
- Exogenous metabolic activation
- Test concentrations with justification for top dose:
- Target dose 2.5 mg/ml; dosing volume of 1 % (10 ul/ml). In DMSO.
Concentration range in the dose range : 4.93 ... 2500 µg/ml.
Reduction in mitotic index of 3% at 625 ug/ml dosed for 3 hours without metabolic activation as compared to vehicle controls.
Reduction in mitotic index of 29 % at 2500 ug/ml dosed for 19.1 hours without metabolic activation as compared to vehicle controls.
No reduction in mitotic index noted when dosed for 3 hours with metabolic activation as compared to vehicle controls.
Concentrations in the initial experiment dosed for 3 hrs, (without metabolic activation): 861-2500 µg/ml and harvested 22 hrs after treatment.
Concentrations in the initial experiment dosed for 3 hrs, (with metabolic activation): 861-2500 µg/ml and harvested 22 hrs after treatment.
Chromosomal aberrations were analyzed from the cultures treated with 861, 1230, 1750 and 2500 µg/ml with and without metabolic activation.
Concentrations in confirmatory test dosed for 19.5 hrs (without metabolic activation): 1130-2500 µg/ml and harvested 22.0 hrs after treatment.
Concentrations in confirmatory test dosed for 43.2 hrs (without metabolic activation): 1130-2500 µg/ml and harvested 46.1 hrs after treatment.
Concentrations in confirmatory test dosed for 3 hrs (with and without metabolic activation): 1130-2500 µg/mg and harvested 22.0 hrs and 46.1 hrs after treatment.
Chromosomal aberrations were analyzed from the cultures treated with 1130, 1500, 2000 and 2500 µg/ml with and without metabolic activation. - Vehicle / solvent:
- vehicle : Dimethylsulfoxide
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9
- Details on test system and experimental conditions:
- initial experiment:
Exposure period (with metabolic activation): 3 hrs
Exposure period (without metabolic activation): 3 hrs
confirmatory experiment:
Exposure period (with metabolic activation): 3 hrs
Exposure period (without metabolic activation): 22.0 and 46.1 hr
at 2 hours before harvest each of the cultures were treated with colcemid solution ( 0.1µg/ml) to block cells at the metaphase stage of mitosis.
cultured medium-for each culture heparinsed whole blood was added to culture medium containing RPMI 1640 supplemented with 15% fetal bovine serum, 1% photohaemogglutinin, 1% penicillin streptomycin and 1% L-glutamine. Total culture volume: 10ml. The culture was incubated on a slope at 37°C in a humidified atmosphere at 5% CO2/95% air for 48 hours. - Evaluation criteria:
- 100 cells from each replicate culture at at least 3 concentrations and the negative and vehicle (solvent) control cultures were analyzed for the different types of chromosomal aberration. At least 25 cells were analyzed for chromosomal aberrations from the positive control cultures.
Mitotic index was assessed by analyzing the number of mitotic cells in 1,000 cells and the ratio was expressed as a ratio of the mitotic cells. - Statistics:
- Cochran-Armitage test for linear trend and Fisher's Exact test comparing treated to veicle controls at p<0.01 significance.
Results and discussion
Test results
- Species / strain:
- human lymphoblastoid cells (TK6)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No appreciable level of toxicity was observed as evident by decreased mitotic index. The test compound was tested to a concentration that required pH adjustment. Test concentrations analyzed for clastogenicity were the highest concentrations tested. Samples of test substance in DMSO were not analyzed for drug content in the test but an assay for stability after the study was completed and found to be stable.
No significant increase in cells with chromosomal aberrations was observed at the concentrations analyzed with and without metabolic activation.
vehicle and positive controls were acceptable and valid. - 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
No significant increase in cells with chromosomal aberrations was observed at the concentrations analyzed with and without metabolic activation.Test substance was considered negative for inducing chromosomal aberrations and results were verified in independently conducted confirmatory assay with multiple harvests.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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