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EC number: 219-401-9 | CAS number: 2432-11-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- m-terphenyl-2'-ol
- EC Number:
- 219-401-9
- EC Name:
- m-terphenyl-2'-ol
- Cas Number:
- 2432-11-3
- Molecular formula:
- C18H14O
- IUPAC Name:
- 3-phenyl-[1,1'-biphenyl]-2-ol
- Details on test material:
- - Name of the test substance used in the study report: 2,6-Diphenylphenol
- CAS name: [1,1':3',1''-Terphenyl]-2'-ol
- Test substance No.: 10/0493-1
- Batch No.: LV 83/2010
- pH-value: ca. 4 (undiluted test substance, moistened with water and 20% aqueous preparation)
- Homogeneity: homogeneous by visual inspection
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor.
Constituent 1
Test animals / tissue source
- Species:
- other: isolated bovine cornea
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM:
- Target tissue: isolated bovine cornea
- Source: Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).
- Supplier: Schlachthof Bensheim, Am Schlachthof 7-9, 64625 Bensheim
Test system
- Vehicle:
- water
- Amount / concentration applied:
- TEST-SUBSTANCE PREPARATION
- Test-substance preparation and homogenization until end of each application period: The test-substance preparation was produced on a weight per volume (w/v) basis shortly before application by stirring with a high speed homogenizer (Ultra-Turrax ) and a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.
- Vehicle: highly de-ionized water
- Reason for the vehicle: Highly de-ionized water has been demonstrated to have no adverse effects on the test system.
- Form of application: 20% (w/v) suspension in highly de-ionized water
APPLICATION:
- Topical application of 750 µL of a 20% test substance preparation to the epithelial surface of three isolated bovine corneas. - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3 isolated bovine corneas
- Details on study design:
- Negative control (NC): Highly de-ionized water
Positive control (PC): Imidazole (CAS No. 288-32-4) 20% (w/v) solution in highly deionized water for non-surfactant solid test substances
Each treatment group (test substance, NC and PC) consisted of 3 corneas. Before application the medium in the anterior chamber was removed. 750 μL of the 20% (w/v) test-substance preparation was applied directly to the epithelial surface of the cornea (open chamber method). Control tissues were concurrently applied into the anterior chamber with 750 μL of highly deionized water (negative control, NC) or with 750 μL of 20% (w/v) solution of Imidazole in highly de-ionized water (positive control, PC). The corneas were incubated in a horizontal position at about 32°C for approximately 4 hours. The NC and PC were then removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red). Because the test substance could not be removed using a syringe, the epithelium was rinsed with the open chamber method.
Before measurement, each cornea was observed visually and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
For determination of permeability the medium in the anterior chamber was replaced by 1 mL sodium fluorescein solution (5 mg/mL for solid test substances) and incubated for 90 ± 5 min in a horizontal position at about 32°C.
The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was measured spectrophotometrically. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.
Results and discussion
Any other information on results incl. tables
Opacity score:
Test substance |
Cornea No. |
Initial opacity |
Final opacity |
Opacity change |
Corrected opacity change |
Mean |
SD |
10/0493-1 |
13 14 15 |
3.2 2.2 2.1 |
7.7 8.7 10.7 |
4.5 6.6 8.6 |
0.4 2.5 4.5 |
2.5 |
2.1 |
NC |
1 2 3 |
0.8 1.3 1.9 |
2.8 2.7 10.9 |
2.0 1.3 8.9 |
NA NA NA |
4.1 |
4.2 |
PC |
4 5 6 |
4.6 2.5 4.7 |
64.1 66.6 82.9 |
59.6 64.2 78.2 |
55.5 60.1 74.1 |
63.2 |
9.7 |
Permeability score:
Test substance |
Cornea No. |
Mean OD490 |
Dilution factor |
Mean corrected OD490 |
Mean |
SD |
10/0493-1 |
13 14 15 |
-0.007 0.006 0.027 |
1 1 1 |
-0.002 0.011 0.032 |
0.014 |
0.018 |
NC |
1 2 3 |
-0.002 -0.006 -0.007 |
1 1 1 |
NA NA NA |
-0.005 |
0.003 |
PC |
4 5 6 |
0.606 0.770 0.701 |
5 5 5 |
3.035 3.853 3.510 |
3.466 |
0.411 |
In Vitro Irritancy Score (IVIS):
Test substance |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
per cornea |
per group |
||||
mean |
SD |
||||
10/0493-1 |
0.4 2.5 4.5 |
-0.002 0.011 0.032 |
0.4 2.6 5.0 |
2.7 |
2.3 |
NC |
2.0 1.3 8.9 |
-0.002 -0.006 -0.007 |
2.0 1.2 8.8 |
4.0 |
4.2 |
PC |
55.5 60.1 74.1 |
3.035 3.853 3.510 |
101.0 117.9 126.8 |
115.2 |
13.1 |
NA = not applicable
Based on the observed results and applying the evaluation criteria it was concluded, that 2,6-Diphenylphenol does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.
Applicant's summary and conclusion
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