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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: E91/414/EEC [Annex III, Point 7]
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA Pesticide Assessment Guidelines Subdivision F, Section 85-2
- Deviations:
- no
- GLP compliance:
- 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: [14C-U-phenoxyphenyl]DPX-JE874
Radiochemical purity: 98%
Specific activity: 61.8 µCi/mg
Substance name: DPX-JE874
Lot #: 352DE1 REF92
Purity: 99.6% - Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- other: CRl:CD(SD)BR
- Sex:
- female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Acetone or deionized water
- Duration of exposure:
- 8, 24, 48, 144 h
- Doses:
- 10 (formulation concentrate), 0.75 (aqueous solution) mg/animal
- No. of animals per group:
- 4
- Control animals:
- no
Results and discussion
- Signs and symptoms of toxicity:
- no effects
- Remarks:
- No overt pharmacological or toxicological signs were observed in the test animals which could have been attributed to the administration of [14C]test substance.
- Total recovery:
- An acceptable material balance (ca 87% of the dermally applied radioactivity, range 84 to 90% for all 4 sampling groups) was attained. The majority of the applied radioactivity was recovered in the back washes (>64% of the dermally applied radioactivity) at the 8 and 24 hours washing intervals, and from the washings of the bandages and protective appliances (5 to 18%). At the 24 h washing interval, only ca 5% of the applied radioactivity remained at the application site after washing. When test animals were sacrificed at the 72 and 168 h sampling intervals, only low levels of radioactivity (0.01 to 0.9%) were recovered from the second back wash and solubilised skin. Low levels of radioactivity were recovered in the excreta, surrounding skin area and remaining carcass. Negligible levels of 14C-residue were observed in the blood with values at, or close to the limit of detection. Approximately 4% of the applied radioactivity (mainly in the faeces) was recovered in the excreta, 168 h after treatment. This distribution data showed the limited in vivo dermal penetration of [14C]test substance after dermal application of DPX-MC444-11 formulation concentrate to female laboratory rats.
The overall distribution profile of the administered [14C]test substance radioactivity in this treatment group after exposure to a dilute aqueous solution of DPX-MC444-11 was similar to that observed with the undiluted concentrate formulation. An acceptable material balance (>85%) was attained. The majority of the applied radioactivity was recovered in the application site skin washes, bandages and protective appliance. Negligible levels of 14C-residue were observed in the blood with values at, or close to the limit of detection. Approximately 11% of the applied radioactivity remained at the application site after the 24 h washing interval, and was subsequently dissipated at the 72 and 168 h sacrifice intervals. Approximately 7% of the applied radioactivity was recovered in the combined excreta (mainly faeces), application skin site and remaining carcass, which further confirmed the limited dermal penetration of [14C]test substance in the diluted aqueous DPX-MC444-11 solution.
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 8 h
- Dose:
- 10 mg [14C]DPX-JE874 (formulation concentrate)
- Parameter:
- percentage
- Absorption:
- 4.31 %
- Key result
- Time point:
- 8 h
- Dose:
- 0.75 mg [14C]DPX-JE874 (aqueous solution)
- Parameter:
- percentage
- Absorption:
- 5.37 %
- Key result
- Time point:
- 24 h
- Dose:
- 10 mg [14C]DPX-JE874 (formulation concentrate)
- Parameter:
- percentage
- Absorption:
- 5.86 %
- Key result
- Time point:
- 24 h
- Dose:
- 0.75 mg [14C]DPX-JE874 (aqueous solution)
- Parameter:
- percentage
- Absorption:
- 13.77 %
- Time point:
- 72 h
- Dose:
- 10 mg [14C]DPX-JE874 (formulation concentrate)
- Parameter:
- percentage
- Absorption:
- 3.07 %
- Time point:
- 72 h
- Dose:
- 0.75 mg [14C]DPX-JE874 (aqueous solution)
- Parameter:
- percentage
- Absorption:
- 9.27 %
- Time point:
- 168 h
- Dose:
- 10 mg [14C]DPX-JE874 (formulation concentrate)
- Parameter:
- percentage
- Absorption:
- 4.93 %
- Time point:
- 168 h
- Dose:
- 0.75 mg [14C]DPX-JE874 (aqueous solution)
- Parameter:
- percentage
- Absorption:
- 10.1 %
Applicant's summary and conclusion
- Conclusions:
- The maximum dermal absorption occurred within 24 hours after exposure. An approximately 2-fold difference in the percent penetration was observed in the aqueous test solution.
- Executive summary:
This study was designed to investigate the in vivo dermal penetration of [14C]test substance (and/or its metabolites) in female laboratory rats, following a single dermal administration of [14C]DPX-MC444-11 formulation at two dose levels: as the undiluted emulsifiable concentrate and as an aqueous dilution of the concentrate equivalent to approximately ten times that of the field application solution.
Overall, limited dermal penetration of test substance was observed. The majority of administered radioactivity was removed at 8 h or 24 h by washing of the application site. Maximal dermal absorption occurred within 24 h after the initial application. Dermal absorption (expressed as the percent of the applied radioactivity) for the aqueous solution was approximately twice that for the formulation concentrate.
Negligible amounts (<1%) of the applied radioactivity was recovered in the urine. Faeces accounted for approximately 6% of the applied radioactivity. The majority of the applied radioactivity was removed in the skin wash.
Analysis of the skin washes, by HPLC, following 24 h exposure showed the presence of a single radioactive component with a retention time consistent with that of the test substance. Excreted radioactivity was largely eliminated as test substance in the faeces with some IN-KZ007 also present.
In conclusion, following a single dermal administration of [14C]test substance, limited dermal penetration was observed, with the majority of excreted radioactivity eliminated in the faeces. Washing the application site effectively removed the majority of applied radioactivity.
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