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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Apr 2015 to 19 Apr 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This in vivo study was conducted to meet the data requirements of regulations not related to REACH in non-EEA countries.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- May 2008
- 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:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Age at study initiation: 12 weeks
- Weight at study initiation: 3113 – 3282 g
- Housing: Individual caging
- Diet: ad libitum.
- Water: Tap water, from an automatic system, ad libitum
- Acclimatisation period: 13 and 15 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1 – 22.4
- Humidity (%): 28 – 53
- Air changes (per hour): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 Apr 2015 To: 19 Apr 2015
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- STUDY DESIGN
In a primary skin irritation study, the test substance was administered at 0.5 g / animal, the dose specified in the test guidelines for a solid test substance. Initially, a single animal was treated. As neither a corrosive effect nor a severe irritant effect were observed after the 24-hour observation, the test was completed using the 2 remaining animals with an exposure period of 4 hours.
The viability/mortality was recorded daily from the day of application of the animals to the termination of test.
Clinical signs were recorded daily and body weights were recorded on the day of application and at termination of observation.
The animals were checked daily for signs of systemic toxicity.
TEST SITE
- Area of exposure: Approximately 24 hours prior to the test the hair was clipped from the back and flanks of the animals with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). Animals with overt signs of skin injury or marked irritation, which may have interfered with the interpretation of the results, were not used in the test.
- Type of wrap: On the day of treatment, 0.5 g of test substance was placed on a surgical gauze pad (ca. 2.5 cm x 2.5 cm) and sufficient water was added to dampen the material to ensure good contact with the skin. This gauze pad was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was then wrapped with plastic wrap held in place with an elastic stocking.
REMOVAL OF TEST SUBSTANCE
- Duration of treatment: 4 hours
- Washing: The dressing was then removed and the skin was flushed with lukewarm tap water to clean the application site.
OBSERVATION TIME POINTS
- Approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test substance.
SCORING SYSTEM:
- Method of calculation: Draize scoring system. The primary irritation index was calculated by totalling the mean cumulative scores at 24, 48 and 72 hours for all animals and then dividing by the number of data points.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 5
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No local dermal signs were observed in the treated animals throughout the study.
- Other effects:
- CLINICAL OBSERVATIONS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
DURATION OF THE IN-LIFE PHASE
As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.
BODY WEIGHT
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of the test substance did not result in any signs of skin irritation.
Under the conditions of this study, the test substance is considered to be "not irritating" to the rabbit skin according to the Draize classification criteria. - Executive summary:
The primary skin irritation potential of the test substance was investigated according to the GLP compliant OECD 404 (2002), OPPTS 870.2500 (1998) and EC No 440/2008, B.4 (2008). Young adult New Zealand White rabbits (3 males) were dermally exposed to 0.5 g of test substance, applied to the intact shaved skin under a semi-occlusive dressing, for 4 hours. Skin reactions were scored at 1, 24, 48 and 72 hours after removal of the dressings according to the Draize Scoring System. The Primary Irritation Index (PII) was calculated.
No local dermal signs were observed in the treated animals throughout the study. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after 72 hours observation. The body weights of all rabbits were considered to be within the normal range of variability. The application of the test substance did not result in any signs of skin irritation.
Under the conditions of this study, the test substance is considered to be not irritating to the rabbit skin according to the Draize classification criteria.
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.