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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2006
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
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
- Remarks:
- White
- Details on test material:
- 95 to >99% purity
Constituent 1
- Specific details on test material used for the study:
- Analytical Purity: 97.4% by analysis; Lot # JULJUL05MA037
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals Source: SAGE™, Boyertown, PA; Weight at study initiation: 178-221g; Fasting period before study: Overnight; Housing: Singly housed in plastic solid bottom polycarbonate cages; Diet: Purina Rodent Chow #5012; Acclimation period: 20-30 days
Environmental conditions: Temperature and Relative Humidity Ranges: 19-23°C and 30-44%, respectively; Photoperiod: 12 hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The sample was administered as a 40% w/w mixture in distilled water. Preliminary solubility testing conducted by EPSL indicated that mixtures in excess of 40% (i.e. 50-80%) were too viscous to be administered properly.
- Doses:
- 175, 550, 1750, and 5000 mg/kg
- No. of animals per sex per dose:
- One rat was adminsitered 175, 550, and 1750 mg/kg and 3 rats were administered 5000 mg/kg
- Control animals:
- no
- Details on study design:
- Based on a limit dose of 5000 mg/kg, a Main Test was conducted using a default starting dose level of 175 mg/kg administered to one healthy female rat by oral gavage. Following the Up and Down procedure, one female each was dosed at 550 or 1750 mg/kg and three females were dosed at 5000 mg/kg. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at terminal sacrifice.
- Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Westat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable
- Remarks:
- No deaths
- Mortality:
- No deaths
- Clinical signs:
- other: No clinical signs of toxicity were observed
- Gross pathology:
- No changes
- Other findings:
- Reduced fecal volume noted on Days 1 and/or 2 for the rat dosed at the 1750 mg/kg level and two rats dosed at 5000 mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 is greater than 5000 mg/kg, the highest dose tested. According to the United Nations Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required.
- Executive summary:
An acute oral toxicity test (Up - and - Down Procedure; OECD 425) was conducted with rats to determine the potential for the test substance to produce toxicity from a single dose via the oral route. Based on a limit dose of 5000 mg/kg, at the request of the Sponsor, a Main Test was conducted using a default starting dose level of 175 mg/kg administered to one healthy female rat by oral gavage. Following the Up and Down procedure, one female each was dosed at 550 or 1750 mg/kg and three females were dosed at 5000 mg/kg. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at terminal sacrifice.
Under the conditions of this study, the acute oral LD50 is greater than 5000 mg/kg of body weight in female rats.
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