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EC number: 223-496-2 | CAS number: 3923-79-3
- 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 gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Remarks:
- Read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Urea, reaction products with formaldehyde and glyoxal
- EC Number:
- 296-664-6
- EC Name:
- Urea, reaction products with formaldehyde and glyoxal
- Cas Number:
- 92908-35-5
- Molecular formula:
- C2 H2 O2 .C H4 N2 O .C H2 O
- IUPAC Name:
- Urea, reaction products with formaldehyde and glyoxal
- Details on test material:
- - Name of test material (as cited in study report): Fixapret CP konz., PBG=10073662, after Concentration
- Physical state: liquid
- Analytical purity: 93.4 %
- Lot/batch No.: 000335MCA0
Constituent 1
Method
- Target gene:
- hypoxanthine-guanine phosphoribosyl transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9 mix (Phenobarbital/ß-naphthoflavone induced)
- Test concentrations with justification for top dose:
- Experiment 1 (in ug/ml): 100, 200, 400, 800, 1200, 1600 without S9 mix; 100, 200, 400, 800, 1200, 1400 with S9 mix
Experiment 2 (in ug/ml): 2.5; 5.0; 10.0; 20.0; 40.0; 60.0 without S9 mix; 100, 200, 400, 800, 1000, 1200 with S9 mix
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionised water
- Justification for choice of solvent/vehicle: The solvent was chosen according to its solubility properties and its relative nontoxicity to the cells. The final concentration of deionised water in the culture medium was 10 % (v/v).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see remarks
- Remarks:
- ethylmethane sulfonate 1.2mM without metabolic activation; 7,12-dimethylbenz(a)anthracene with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 h
- Exposure duration: 4 h/ 24 h
- Expression time (cells in growth medium): 7 days
- Fixation time (start of exposure up to fixation or harvest of cells): 15 days
SELECTION AGENT (mutation assays): thioguanine 11 µg/ml (Sigma)
NUMBER OF REPLICATIONS: 2 - Evaluation criteria:
- The gene mutation assay is considered acceptable if it meets the following criteria:
- the numbers of mutant colonies per 106cells found in the solvent controls fall within the laboratory historical control data range (see Annex II).
- the positive control substances must produce a significant increase in mutant colony fre-quencies (see Annex II, Historical data).
- the cloning efficiency II (absolute value) of the solvent controls must exceed 50 %. - Statistics:
- A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT11 (SYSTAT Software, Inc., 501, Canal Boulevard, Suite C, Richmond, CA 94804, USA) statistics software. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological and statistical significance were considered together.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No phase separation of the test item was observed up to the maximum concentration in all experimental parts.
Cytotoxic effect as indicated by a relative cloning efficiency I of less than 50 % in both parallel cultures occurred at the maximum evaluated concentration of 1200 g/ml in experiment I with and without metabolic activation following 4 hours of exposure. In experiment II cytotoxic effects as described above were observed at the maximum evaluated concentration of 60 g/ml without metabolic activation (24 hours treatment) and at 800 g/ml and above with metabolic activation (4 hours treatment). The relative cloning efficiency I covered the recommended cytotoxic range of approximately 10-20% with and without metabolic activation.
No relevant and reproducible increase in mutant colony numbers/106cells was observed in the main experiments up to the maximal concentration. The mutant frequency remained well within the historical range of solvent controls. The induction factor exceeded the threshold of three times the corresponding solvent control in the first culture of the first experiment at 1200 g/ml with metabolic activation. This isolated increase was judged as biologically irrelevant since it was not reproduced in the parallel culture performed under identical conditions, and the total number of mutant colonies/106cells did not exceed the range of the historical solvent control values. Furthermore, the isolated increase was not dose dependent as indicated by the lacking statistical significance. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- In conclusion it can be stated, that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.
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