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EC number: 618-690-2 | CAS number: 90982-32-4
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Similar to OECD Guideline 475 with significant methodological deficiencies. The power of the assay is too low and there is no evidence of target cell (bone marrow) exposure.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study was designed to evaluate the clastogenic potential of the test substance as measured by increases in numerical and structural chromosomal aberrations in rat bone marrow cells. A single dose of the test material was administered by oral gavage to three groups of 20 male and 20 female rats at levels of 500, 1500, and 5000 mg/kg of body weight. At approximately 4, 10, 22, and 46 hours after administration of the test and control substances the appropriate groups of animals received a single intraperitoneal injection of colchicine to inhibit mitosis and arrest cells in metaphase and the animals were sacrificed after 2 hours of injection and bone marrow cells collected to prepare slides for measuring the numerical and structural chromosomal aberrations.
- GLP compliance:
- no
- Type of assay:
- other: Chromosomal aberration assay
Test material
- Reference substance name:
- ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate
- EC Number:
- 618-690-2
- Cas Number:
- 90982-32-4
- Molecular formula:
- C15H15ClN4O6S
- IUPAC Name:
- ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity: 96%
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD (albino)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Frequency of treatment:
- Once
- Post exposure period:
- 6, 12, 24, and 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw (total dose)
- Dose / conc.:
- 1 500 mg/kg bw (total dose)
- Dose / conc.:
- 5 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 20
Positive control: 5 - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow
- Statistics:
- The mean mitotic indices, mean modal numbers, percent aberrant cells and the mean number of aberrations per cell for each group were statistically compared using the Kruskal-Wallis nonparametric analysis of variance and nonparametric pairwise group comparisons (KW-ANOVA). Body weight data was analyzed by analysis of covariance (ANCOVA). All analyses were one-tailed at the 95% confidence level (p <0.05).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test substance is considered not to be clastogenic at any of the levels tested.
- Executive summary:
This study was designed to evaluate the clastogenic potential of the test substance as measured by increases in numerical and structural chromosomal aberrations in rat bone marrow cells from Charles River Sprague-Dawley, CD rats. A single dose of the test material was administered by oral gavage to three groups of 20 male and 20 female rats at levels of 500, 1500, and 5000 mg/kg of body weight.
5 males and 5 females from each group were sacrificed at 6, 12, 24, and 48 hours after the single administration of the test material. Results show that no statistically significant increases in the frequency of chromosomal aberrations compared to control values were seen for any of the dose levels that were tested. No statistically significant differences were seen between the mean modal numbers and the mean mitotic indices of the test groups and the vehicle controls.
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