Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 954-921-6 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl)-N-(2-ethyl-3-oxo-1,2-oxazolidin-4-yl)-2-methylbenzamide
- Cas Number:
- 2061933-85-3
- Molecular formula:
- C23H19Cl2F4N3O4
- IUPAC Name:
- 4-(5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl)-N-(2-ethyl-3-oxo-1,2-oxazolidin-4-yl)-2-methylbenzamide
- Test material form:
- liquid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: Human
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: The study was performed with a formulated product (suspension concentrate formulation type) containing the radiolabelled test substance at a concentration of 200 g/L
- Duration of exposure:
- 10 hours
- Doses:
- Formulation concentrate (200 g/L), Spray dilution 1 (7.5 g/L), Spray dilution 2 (2 g/L), Spray dilution 3 (0.2 g/L): 10 µL/cm2, 6.4 µL/cell
- Details on in vitro test system (if applicable):
- A static diffusion cell with an exposed skin area of 0.64 cm2 was used for all tests. The membranes consisted of dermatomed skin with a thickness of 350 to 400 µm, obtained from male rats, 8 to 12 weeks old. Their integrity was tested by measuring the electrical resistance.
The receptor medium consisted of Phosphate buffered saline containing polyoxyethylene 20 oleyl ether (PEG, ca 6%, w/v), sodium azide (ca 0.01%, w/v), streptomycin (ca 0.1 mg/mL) and penicillin (ca 100 units/mL) at pH 7.4 + 0.1.
The exposure time was 10 hours, the following observation period was 14 hours. Samples were taken pre-dose, then after 2, 4, 6, 8, 12 and 24 hours. Washing was performed after the exposure period and at the end of the observation period. Tape stripping was performed as final procedure, and the strips were analysed separately.
The human skin was obtained from human female and male donors at the age of 28 to 63 years. The skin was taken from the abdomen, the arms or the breast. The number of valid and used cells per test concentration was 8.
Results and discussion
- Total recovery:
- 200 g/L: 100 ± 10% for individual cells (n = 8), mean = 99.03%
7.5 g/L: 100 ± 10% for individual cells (n = 8), mean = 100.84%
2 g/L: 100 ± 10% for individual cells (n = 8), mean = 100.62%
0.2 g/L: 100 ± 10% for individual cells (n = 8), mean = 98.51%
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 24 h
- Dose:
- 200 g/L
- Parameter:
- percentage
- Absorption:
- 0.01 %
- Key result
- Time point:
- 24 h
- Dose:
- 7.5 g/L
- Parameter:
- percentage
- Absorption:
- 0.02 %
- Key result
- Time point:
- 24 h
- Dose:
- 2.0 g/L
- Parameter:
- percentage
- Absorption:
- 0.09 %
- Key result
- Time point:
- 24 h
- Dose:
- 0.2 g/L
- Parameter:
- percentage
- Absorption:
- 0.18 %
Applicant's summary and conclusion
- Conclusions:
- The dermal absorption of substance through human split-thickness skin membranes over a period of 24 hours was 0.01% for the formulation concentrate (200 g/L) and ranged from 0.02%, 0.09% to 0.18% for spray dilutions (7.5, 2.0 and 0.2 g/L).
- Executive summary:
The in vitro dermal absorption of the substance from a suspension concentrate was studied under GLP to OECD TG 428 using split-thickness human skin. Split-thickness membranes were prepared from full thickness membranes obtained from 28 to 63 years old female and male human donors. All tests were conducted in static diffusion cell systems, and the exposed skin surface within the cells was 0.64 cm2. All cells were placed on a magnetic stirrer plate that could be heated to maintain a skin surface temperature of 32 ± 1°C. The study was performed with a suspension concentrate formulation containing 200 g/L of radiolabelled test substance and with in-use dilutions containing 7.5, 2.0 or 0.2 g/L radiolabelled test substance. Aliquots of 10 μL of each test solution were applied per cm2 of skin membranes and left unoccluded for an experimental period of 24 h, with an interim wash at 10 h post-application. The absorption process was followed by collecting samples of the receptor fluid, phosphate buffered saline containing polyoxyethylene 20 oleyl ether (PEG, ca 6%, w/v), sodium azide (ca 0.01%, w/v), streptomycin (ca 0.1 mg/mL) and penicillin (ca 100 units/mL), pH 7.4 ± 0.1, at recorded intervals throughout the experimental period. The distribution of the substance within the test system and a 24 h absorption profile was determined using liquid scintillation counting. The study demonstrated that the amount of substance absorbed through human split-thickness skin membranes over 24 h (following a 10 h exposure) from the formulation concentrate (200 g/L) was 0.01% and the intended in-use dilutions (7.5 g/L, 2 g/L and 0.2 g/L) was 0.02%, 0.09% and 0.18% of the applied dose, respectively, as measured in the receptor fluid and receptor chamber wash.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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