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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Testing Guidelines for Toxicology Studies NohSan 59, No. 4200
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
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 name: DPX-JE874
Lot #: DPX-JE874-221
Purity: 97.4%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®BR
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water containing 0.5% Tween 80
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- on days 7-16 of gestation
- Frequency of treatment:
- Once daily
- Duration of test:
- 10 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 125 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No compound-related effects on the incidence or type of clinical observations were seen at any dose level.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Two rats died prior to scheduled sacrifice but neither death was related to administration of the compound. One rat in the control group sacrificed in extremis on Day 15G after clinical observations suggestive of gavage trauma were recorded. Postmortem observations confirmed that the animal had been misdosed. One rat in the 125 mg/kg/day group was found dead was Day 5G. The urinary bladder obstructed with a calculus, causing hydronephrosis. Since this animal died before dosing started, another animal was assigned to the 125 mg/kg/day group.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight gains were significantly reduced at 500 and 1000 mg/kg/day over 7-9G. No other effects on maternal weights, weight gains, or adjusted weights were seen.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal food consumption was significantly reduced at 500 and 1000 mg/kg/day over 7-9G. For the 1000 mg/kg/day group, a rebound in food consumption was observed as the mean food consumed over days 17-22G was significantly increased. No other effects on maternal food consumption were seen.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No compound-related effects were detected during the gross postmortem examinations.
Maternal developmental toxicity
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No compound-related effects on fetal mortality were observed. The incidence of early, late, or total resorptions was comparable across dose groups. At the high dose level, there was on litter that consisted of two dead fetuses. However, at necropsy, the maternal uterus was observed to be twisted and distended with red fluid. This finding is not believed to be compound related.
- Other effects:
- no effects observed
- Description (incidence and severity):
- No compound-related effects on any reproductive parameter (pregnancy rate, incidence of dams with total resorptions, mean corpora lutea, mean number of implantations, mean number of live and dead fetuses per litter, and mean sex ratio) were detected.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Mean fetal weight was unaffected by exposure to the test substance
- Other effects:
- no effects observed
- Description (incidence and severity):
- No compound-related effect on the incidence of any fetal malformation was detected.
No compound-related effect on the incidence of any fetal variation was detected.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: highest dose tested
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Rat NOAEL: 250 mg/kg/day (maternal toxicity); 1000 mg/kg/day (developmental toxicity, highest dose tested)
- Executive summary:
This study was conduted following OECD guideling 414 and US EPA 83-3. The test substance was administered by gavage to groups of 25 Crl:CD®BR female rats on days 7-16 of gestation at dose levels of 0, 125, 250, 500, or 1000 mg/kg/day. Maternal toxicity was evident at 500 and 1000 mg/kg/day as significant dose-related decreases in maternal body weight gain and food consumption. No evidence of maternal toxicity was detected at 250 or 125 mg/kg/day. Therefore, under the conditions of this study, the maternal NOAEL was 250 mg/kg/day. Developmental toxicity was not detected at any dose level. The NOAEL for developmental toxicity was 1000 mg/kg/day. The test substance is not considered to be uniquely toxic to the conceptus.
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