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Diss Factsheets
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EC number: - | 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:
- From 2012-09-25 to 2012-09-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone
- Cas Number:
- 1398609-39-6
- Molecular formula:
- C23H18Cl2F4N2O5S
- IUPAC Name:
- 1-(5'-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'-H-spiro(azetidine-3,1'-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone
Constituent 1
- Specific details on test material used for the study:
- Lot No.: PF-06450567-00-0022
Purity: Not provided
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rich-Glo II, Inc; Wills Point, TX
- Age at study initiation: ca. 3 months
- Weight at study initiation: 2.229-2.824 kg
- Housing: Suspended, wire bottom, stainless steel, 1 per cage
- Diet: PMI Feeds, ca. 8 oz. daily
- Water: Municipal water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-89
- Air changes (per hr): 10-12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: From: 25 Sep 12 To: 28 Sep 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg of test item moistened with 0.5 mL of DI water
- Duration of treatment / exposure:
- 4 hous
- Observation period:
- 72 hours
- Number of animals:
- 1 male, 2 females (nulliparous & non-pregnant)
- Details on study design:
- TEST ITEM ADMINISTRATION
On Day 0, 500 mg of test item moistened with 0.5 mL of DI water was applied to each test site and covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) which was secured on both edges with strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test item.
REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test item as possible.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
The test sites were observed for erythema and edema formation, and any other dermal effects at 1, 24, 48 and 72 hours after unwrap.
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Erythema and edema were not observed at any time throughout the study. No other dermal effects were observed during the study.
Any other information on results incl. tables
Individual dermal irritation scores:
Animal No. | Erythema score | Edema score | ||||
24 h | 48 h | 72 h | 24 h | 48 h | 72 h | |
1 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary irritation index of 0.0 out of a possible 8.0 was obtained from the observations at 1, 24, 48 and 72 hours, and was used to give test item a descriptive rating of non-irritating.
- Executive summary:
A primary dermal irritation study was conducted on three albino rabbits using test item in accordance with OECD 404.
There was one intact test site per animal. Each test site was treated with 500 mg of test item moistened with 0.5 mL of DI water and covered with a semi-permeable dressing. The test item was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings.
The erythema and edema scores for each animal are all 0 for 24, 48, and 72 h observations.
The test item is rated non-irritating.
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