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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of Agriculture, Forestry and Fisheries Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
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#: JE874-221
Purity: 97.4%
Test animals
- Species:
- mouse
- Strain:
- other: Crl:CD®_1(ICR)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Inc., Saint Constant, Quebec, Canada
- Age at study initiation: Approximately 53 days old
- Weight at study initiation: Male: 28.5-34.2 g; Female: 24.0-28.1 g
- Assigned to test groups randomly: Yes
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 50 ± 10%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Immediately prior to dosing, suspensions of the test substance in the vehicle were prepared at concentrations of 200, 100, and 50 mg/mL. Uniformity was maintained during dosing by constant stirring. Single acute doses of the appropriate suspensions were administered by oral intubation at 25 mL/kg, yielding treatments of 5000, 2500, and 1250 mg test substance/kg body weight.
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- Single dose
- Post exposure period:
- 24, 48, 72 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 250 mg/kg bw (total dose)
- Dose / conc.:
- 2 500 mg/kg bw (total dose)
- Dose / conc.:
- 5 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 6 (high dose group); 5 (rest of the groups)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- The CP was administered by intraperitoneal injection in a volume of 5 mL/kg. An 8.0 mg/mL CP solution was used, yielding a dose of 40 mg/kg.
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Mice were treated with either the test substance, vehicle or positive indicator on the day following release from quarantine. Groups of 6 male and 6 female mice (high dose group) and 5 male and 5 female mice (negative control) were sacrificed approximately 24, 48, and 72 hrs post-dosing. For the intermediate and low dose groups, 5 males and 5 females were sacrificed 24 hrs post-dosing. A positive indicator group of 5 male and 5 female mice was concurrently treated and sacrificed approximately 24 hrs post-dosing.
DETAILS OF SLIDE PREPARATION: Immediately after sacrifice, marrow from both femurs of each animal was aspirated and flushed into approximately 3 mL prewarmed (37°C) fetal bovine serum. The marrow was collected by centrifugation (approximately 200 x g, 5 min). Most of the supernatant was removed and the cells were resuspended in the remaining 1-2 drops of serum. A Miniprep® automatic blood smearing instrument was used to prepare marrow smears. At least 3 slides per animal were prepared and fixed in absolute methanol for 8 min. Slides were stained for 3 min in 0.0125 mg/mL acridine orange in phosphate buffer (pH 7.4). Prior to scoring, a coverslip was floated on each slide using phosphate buffer. - Statistics:
- Data for the proportion of PCEs and MNPCEs among 2000 erythrocytes (PCE frequency and MNPCE frequency, respectively) were transformed prior analysis using the arcsin square root function. This transformation appropriate for proportions since the distribution of the transformed data more closely approximates a normal distribution than do the nontransformed proportion. Transformed data for PCE or MNPCE frequency were analyzed separately for normality of distribution using the Shapiro-Wilkes test. If results indicated that the transformed values for PCE:MNPCE frequency normally distributed in both sexes, parametric methods (viz., Analysis of Variance (AN0VA) and Dunnett test) were used. If there was nonnormality in either sex, nonparametric methods (viz., Kruskal-Wallis test and Mann-Whitney U tests) were used for that variable using nontransformed proportions. Positive indicator data were not included in evaluating normality of distribution. Weight gain data were assumed to be normally distributed and were analyzed by ANOVA. Data from each sex and sacrifice time were analyzed separately, and individual comparisons to the control were made using each animal as the experimental unit. All analyses conducted at a significance level of 5%. Positive indicator data were analyzed separately.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- other: equivocal
- Remarks:
- equivocal based on the incidence of soft stools and diarrhoea which are likely to be related to the corn oil dosing vehicle (possibly affecting absorption of the test material in the treated mice).
- Toxicity:
- yes
- Remarks:
- wet perineum and/or soft stools, diarrhea
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test substance did not induce micronuclei in bone marrow cells of mice; the material is negative in this in vivo assay.
- Executive summary:
This study was conducted following US EPA 84-2 and OECD guideline 474. The test substance evaluated for its ability to induce micronuclei in bone marrow polychromatic erythrocytes (PCEs) of Crl:CD®-1(ICR)BR mice. Acute doses of 0, 1250, 2500, and 5000 mg/kg administered by oral intubation to male and female mice. In the control and high dose groups, bone marrow smears were prepared approximately 24, 48, and 72 hrs after dosing. In the intermediate and low dose groups, prepared approximately 24 hrs after dosing. Two thousand PCEs per animal were scored for micronuclei.
No statistically significant increases in the frequency of micronucleated PCEs were observed in test substance treated mice at any dose level or sampling time. In addition, no statistically significant depression in the proportion of PCEs among 1000 erythrocytes were observed. In this assay, the test substance is negative.
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