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EC number: 603-520-1 | CAS number: 131807-57-3
- 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
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:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- 5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione
- EC Number:
- 603-520-1
- Cas Number:
- 131807-57-3
- Molecular formula:
- C22H18N2O4
- IUPAC Name:
- 5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Substance ID: DPX-JE874-498
Batch #: JEGX150811
Purity: 98.8%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 10-11 weeks
- Weight at study initiation: 213.1 to 239.2 g
- Fasting period before study: Yes (approximately 17-17.5 hours prior to dosing)
- Housing: Animals were housed individually in solid-bottom caging with bedding and appropriate species-specific enrichment.
- Diet: ad libitum except during fasting
- Water: ad libitum except during fasting
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-26ºC
- Humidity: 30-70%
- Photoperiod: 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.1% Tween 80 (V/V) in 0.5% methylcellulose
- Details on oral exposure:
- A single oral dose of test substance, suspended in 0.1% Tween 80 (V/V) in 0.5% methylcellulose, was administered by oral gavage to fasted female rats at a dose level of 5000 mg/kg. The rats were dosed one at a time.
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 03
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical signs: Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, or abnormal behavior.
- Frequency of observations and weighing: Animals were weighed on test days -1, 1, 8, and 15, and were observed for clinical signs at the beginning of fasting, just before dosing (test day 1), once during the first 30 minutes after dosing and 3 more times on the day of dosing, and once each day thereafter.
- Necropsy of survivors performed: Yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Discolored feces was noted in one animal on the day of dosing (test day 1), which resolved by test day 2.
- Gross pathology:
- No gross lesions were present in the rats at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 (Female Rat): >5000 mg/Kg body weight
- Executive summary:
The acute oral toxicity study was performed according to the Up-and-Down Procedure (OECD 425) and OPPTS 870.1100.
A single dose of test substance was administered by oral gavage to fasted female rats at a dose level of 5000 mg/kg. The rats were dosed one at a time. All rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. The rats were necropsied to detect grossly observable evidence of organ or tissue damage.
There were no instances of mortality and no overall (test day 1-15) body weight losses. Discolored feces was noted in one animal on the day of dosing (test day 1), which resolved by test day 2.
No gross lesions were present in the rats at necropsy.
Under the conditions of this study, the oral LD50 for the test substance was greater than 5000 mg/kg for female rats.
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