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EC number: 610-847-3 | CAS number: 524709-77-1
- 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:
- August 31, 2015 - January 27, 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on July 28, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
- EC Number:
- 610-847-3
- Cas Number:
- 524709-77-1
- Molecular formula:
- C28H26OF6
- IUPAC Name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
0.5 g of the solid test item was applied per animal. Before application, the test item was grounded in a mortar using a pestle and mixed with liquid paraffin.
For the treatment of animal no. D26580, 0.70 g of the test item was moistened with 0.38 g of liquid paraffin. 0.77 g of the test item preparation was applied to the animal.
For the treatment of animal nos. D26556 and D26589, 1.40 g of the test item was moistened with 0.71 g of liquid paraffin. 0.75 g of the test item preparation was applied to each animal, respectively.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, France
- Age at study initiation: 12 - 13 weeks
- Weight at study initiation: 2.67 - 2.78 kg
- Housing: separately in special rabbit cages (manufacturer: Becker, type K99/30 KU)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 19.1°C
- Humidity (%): 44.3 - 74.3%
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12hrs light
IN-LIFE DATES: From: day 1 To: day 8
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Liquid paraffin
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test item was applied per animal.
VEHICLE
Designation: Art. 1.07174
Synonym: Liquid paraffin
Supplier: Merck KGaA, Germany
Batch: K45409474
Released until: April 30, 2019 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
The backs and flanks of all rabbits were shorn 24 hours before administration of the test item with electric clippers equipped with a 1/10 mm shaver head. Only animals with healthy, intact skin were used for the study.
The test item was applied to a gauze patch measuring 6 cm2 (Verbandmull ZZ; Paul Hartmann AG, Heidenheim, Germany). This patch was fixed at the left half of the animals' back. During the time of exposure (4 hours), the application site was covered with a non-irritating tape (Fixomull® stretch; BSN medical GmbH, Hamburg, Germany). After the exposure time, the patch was removed and any residues of the test item were wiped off with a dry cloth.
REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
Local irritations or any clinical systematic alteration were evaluated immediately after patch removal, then 60 minutes, 24 hours, 48 hours and 72 hours thereafter according to Draize (Draize, 1959) and recorded individually for each animal on a record sheet. A daily evaluation was continued up to study day 8.
SCORING SYSTEM:
- Method of calculation: according OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No clinical symptoms and no signs of skin irritation were observed.
- Other effects:
- - Other adverse local effects: no
- Other adverse systemic effects: no
Any other information on results incl. tables
Objective
The objective of the present study was to investigate the primary skin irritating potential of the test item in rabbits.
Study design
The test item was mixed with liquid paraffin to ensure good contact with the skin. Afterwards, the test item was spread onto patches and applied to the healthy, intact skin of previously shaven rabbits for 4 hours under semi-occlusive conditions. Untreated shaven skin areas of the rabbit served as control. The first examination of the treated and untreated skin was performed immediately after patch removal and then after 60 minutes. Thereafter, examinations were performed daily for further 7 days.The study was performed initially with one animal, followed by the confirmatory test with two further animals.
Results
No mortality occurred during the experimental phase of the study.
The body weight development of the treated rabbits was inconspicuous.
No clinical symptoms and no signs of skin irritation were observed.
Conclusions
Under the conditions of the present study, no skin irritation potential was detected for the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, no skin irritation potential was detected for the test item.
- Executive summary:
This study was performed according to GLP and methods applied are fully compliant with OECD TG 404. Under the conditions of the present study, no skin irritation potential was detected for the test item.
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