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EC number: 607-957-9 | CAS number: 26567-10-2
- 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 guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,3',5,5'-tetramethyl-[1,1'-biphenyl]-2,2'-diol
- EC Number:
- 607-957-9
- Cas Number:
- 26567-10-2
- Molecular formula:
- C16 H18 O2
- IUPAC Name:
- 3,3',5,5'-tetramethyl-[1,1'-biphenyl]-2,2'-diol
Constituent 1
Test animals / tissue source
- Species:
- other: Chicken eyes
- Strain:
- other: ROSS 308
- Details on test animals or tissues and environmental conditions:
- Chicken heads were collected after slaughter in a commercial abattoir from young chickens (approximately 6-7 weeks old) which are used for human
consumption. Heads were collected by a slaughter house technician and transported at ambient temperature at the earliest convenience.
After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with physiological saline solution, then placed in a lockable plastic box (4-5 heads per box). The heads were received and processed within approximately 2 hours after collection.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3 positive control treated eyes and 1 negative control eye were examined during the study.
- Amount / concentration applied:
- - Test item: 30 mg applied onto the entire surface of the cornea
- Positive control: 30 mg powdered Imidazole
- Negative control: 30 µL of physiological saline - Duration of treatment / exposure:
- Single exposure of 10 seconds
- Observation period (in vivo):
- 30, 75, 120, 180 and 240 minutes after the post-treatment rinse
- Number of animals or in vitro replicates:
- 3 test item treated eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with 20 mL physiological saline solution at ambient temperature
- Time after start of exposure: 10 seconds from the end of the application
OBSERVATION AND ASSESSMENT OF CORNEAL EFFECTS
Corneal thickness and corneal opacity were measured at all time points. Fluorescein retention was measured on two occasions, at baseline (t=0) and approximately 30 minutes after the post-treatment rinse. Haag-Streit Bern 900 slit-lamp microscope was used for the measurements.
Results and discussion
In vitro
Results
- Remarks on result:
- not determinable because of methodological limitations
- Other effects / acceptance of results:
- Although the treatment with test item did not cause any effect, the cornea surfaces were not cleared 180 or 240 minutes after the post-treatment rinse. This fact might indicate morphological changes in an in vivo system (although during in vivo conditions the eyelids will probably clear the surface, but abrasion may occur). Thus, based on this in vitro eye irritation test the test item can not classified as a severe irritant and not classified as non-irritant. However, for precautionary reasons the test item is classified as an eye irritant.
Any other information on results incl. tables
Test item:
Observation |
Value |
ICE Class* |
Mean maximum corneal swelling at up to 75 min |
0.0% |
I |
Mean maximum corneal swelling at up to 240 min |
0.0% |
I |
Mean maximum corneal opacity |
0.17 |
I |
Mean fluorescein retention |
0.33 |
I |
Other Observations |
Remained test item on the surface of the cornea was detected until the 240-min observation point |
|
Overall ICE Class* |
3xI |
Negative control:
Observation |
Value |
ICE Class* |
Mean maximum corneal swelling at up to 75 min |
0.0% |
I |
Mean maximum corneal swelling at up to 240 min |
0.0% |
I |
Mean maximum corneal opacity |
0.00 |
I |
Mean fluorescein retention |
0.00 |
I |
Other Observations |
None |
|
Overall ICE Class* |
3xI |
Positive control:
Observation |
Value |
ICE Class* |
Mean maximum corneal swelling at up to 75 min |
3.3% |
I |
Mean maximum corneal swelling at up to 240 min |
8.0% |
II |
Mean maximum corneal opacity |
3.67 |
IV |
Mean fluorescein retention |
3.00 |
IV |
Other Observations |
Remained positive control substance on the surface of the cornea was detected until the 240-min observation point |
|
Overall ICE Class* |
1xII 2xIV |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on this in vitro eye irritation test in isolated chicken eyes classification is not possible. However, for precautionary reasons the test item is classified to be irritating to the eye.
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