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Diss Factsheets
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EC number: 946-992-7 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 20, 1982 to August 10, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Study conducted according to GLP and was equivalent or similar to OECD 405 guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4-di-tert-pentylphenol
- EC Number:
- 204-439-0
- EC Name:
- 2,4-di-tert-pentylphenol
- Cas Number:
- 120-95-6
- Molecular formula:
- C16H26O
- IUPAC Name:
- 2,4-bis(1,1-dimethylpropyl)phenol
impurity 1
- Specific details on test material used for the study:
- The test material is a UVCB
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Rabbits were housed individually in cages sized in accordance with the 'Guide for the Care and Use of Laboratory Animals' of the Institute of Laboratory Resources. Waste material was removed daily. Cages and feeders were sanitized every two weeks. Food and water was provided ad libitum, checked daily and added or replaced as needed.
ENVIRONMENTAL CONDITIONS
Temperature: 20 ◦C ± 3 ◦C
Relative Humidity: 30-70%
Light cycle: 12 hours light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 mL of neat test material
- Duration of treatment / exposure:
- Test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then held together for one seconf to prevent loss of material
- Observation period (in vivo):
- Up to 21 days post dosing
- Number of animals or in vitro replicates:
- six animals (3 males, 3 females)
- Details on study design:
- Twenty four hurs prior to the application of the test material, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing preexisting corneal injury were eliminated from the study. The test susbtance was placed in the right eye of each animal by gently pulling the lower lid away from hte eyeball (conjunctival cul de sac) to form a cup. The upper and lower lids were then gently held together for one seconf to prevent loss of material. The contralateral eye remained untreated and served as a control. The eyes were examined at 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment. The grades of ocular reaction were recorded at each examination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.973
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.86
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.996
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.16
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 21 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results of this study, the test material is considered to cause irreversible damage to the eye. Therefore, under the criteria set forth in the CLP guidance document, this substance should be classified as Eye Damage, H318.
- Executive summary:
The test article was instilled in the right eye of six rabbits. Positive ocular responses were observed at 1, 24, 48 and 72 hours, and on Days 7, 14 and 21 after treatment. Blistering and ulceration of the cornea, pannus and keratoconus were observed during the study. Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the test substance was determined to be corrosive to the eye under CLP classification criteria.
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