Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 Mar 2016 to 24 Mar 2016
- 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:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 1987
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, B.3 (L 142)
- Version / remarks:
- May 2008
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:(WI) Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Female rats were nulliparous and nonpregnant
- Age at study initiation: Young adult rats
- Weight at study initiation: 212 - 251 g
- Identification: Animals were identified by numbers written on the tail with an indelible marker. The cages were marked with individual identity cards with information about study number, sex, cage number, dose group and individual animal number.
- Housing: Animals were housed individually in Type II polypropylene/polycarbonate cages. Rodents were housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Randomization: Selected by hand at time of delivery
- Acclimatization time: 5 or 7 days
- Diet: Autoclavable complete diet for rats and mice – breeding and maintenance, ad libitum
- Water: tap water, from the municipal supply, provided in 500 mL bottles ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 – 24.4
- Humidity (%): 31 - 61
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 08 Mar 2017 To: 24 Mar 2017
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- The back of the animal was shaven (approximately 10 % area of the total body surface) approximately 24 hours prior to the treatment. Only those animals without injury or irritation on the skin were used in the test.
On test Day 0, the test substance was applied as a single dose of 5000 mg/kg body weight, moistened with water, and distributed as uniformly as possible over the skin and remained on the skin throughout a 24-hour exposure period. Sterile gauze pads were placed on the skin of rats at the site of application. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours. At the end of the exposure period, residual testsubstance was removed, using body temperature water - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXPERIMENTAL DESIGN
A single administration was performed by the dermal route and was followed by a 14-day observation period.
One male and one female sentinel rats were dosed initially and the remaining four male and four female rats were dosed 48 hours later when it was clear there were no adverse effects.
CLINICAL OBSERVATIONS
A clinical examination was performed on the day of treatment, at 1 and 5 hours after the application of the test item, and once each day for 14 days thereafter.
Observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
SKIN IRRITATION
Adverse skin reactions at the site of application were recorded daily following the removal of the dressing.
MEASUREMENT OF BODY WEIGHT
The body weight of all animals was recorded on Day 0 (day of treatment), and on Days 7 and 14.
POST MORTEM INVESTIGATIONS
All animals were subjected to gross macroscopic examination. All animals were anaesthetised with Euthanimal 40% (Pentobarbital sodium 400 mg/mL) and exsanguinated. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. Any gross macroscopic findings were recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: There were no adverse clinical signs noted in any animals throughout the study.
- Gross pathology:
- There was no evidence of the test item-related observations at a dose level of 5000 mg/kg bw at necropsy.
- Other findings:
- No treatment related skin irritation was observed in any animal throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of the test substance after a single dermal administration was found to be greater than 5000 mg/kg bw in male and female CRL:(WI) Wistar rats.
- Executive summary:
In a OECD 402 study, in compliance with GLP, five male and five female Crl:WI rats were treated with a single semi-occlusive dermal application of test substance at the limit dose of 5000 mg/kg bw. The application period was 24 hours, followed by a 14-day observation period. Clinical observations along with a check of viability and mortality were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. All animals were euthanised and subjected to a gross macroscopic examination at the end of the 2 week observation period (Day 14).
No mortality occurred during the study. No adverse clinical signs were observed after treatment with the test substance or during the 14 day observation period and no effects were observed at the site of application. There were no treatment related body weight changes. Body weights for the animals were within the range commonly recorded for this strain and age. No macroscopic changes were observed at necropsy. The median lethal dose (LD50) of test substance after a single dermal administration was greater than 5000 mg/kg bw in male and female Crl:WI rats
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.