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Diss Factsheets
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EC number: 202-679-0 | CAS number: 98-54-4
- 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:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- reliability scoring based on 2002 guideline.
- Deviations:
- yes
- Remarks:
- - Humidity, temperature, housing conditions not provided
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-tert-butylphenol
- EC Number:
- 202-679-0
- EC Name:
- 4-tert-butylphenol
- Cas Number:
- 98-54-4
- Molecular formula:
- C10H14O
- IUPAC Name:
- 4-tert-butylphenol
- Details on test material:
- - Name of test material (as cited in study report): para-tertiary butylphenol, UCAR Butylphenol 4T-Flake (para tert-Butyl Phenol), PTBP.
- Physical state: White flakes.
- Analytical purity: Not reported.
- Lot/batch No.: Charge No. 496500; BRRC Sample No. 48-186.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Denver, PA.
- Age at study initiation: Not reported.
- Weight at study initiation: 2 to 3 kg.
- Fasting period before study: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): Animals were maintained on appropriate commercial diet, ad libitum.
- Water (e.g. ad libitum): Animals were maintained on municipal water, ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Primary ocular irritation of PTBP was assessed by placing 10 or 80 mg of dry, finely ground powder into the lower conjunctival sac of one eye of each of 3 male and 3 female rabbits per dose level.
- Duration of treatment / exposure:
- 1 second / single exposure.
- Observation period (in vivo):
- 21 days after dosing.
- Number of animals or in vitro replicates:
- 3/sex/dose
- Details on study design:
- The lids were then held together for one second. The eyes were not rinsed after exposure to the chemical. The eyes were scored by the system listed in Attached File 1, which is based on the method of Draize et al., 1944, 1959. Examination of the eyes was performed prior to dosing and at 1, 4, and 24 hours and 2, 3, 7, 14, and 21 days after dosing. Corneas were also stained with 2% fluorescein at all intervals except at 1 and 4 hour post-dosing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 24 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 1 and 4 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 4 h; Scoring not possible beyond 4 h because of conjunctival swelling or corneal opacity.
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 24 h and 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- - 80 mg
- Time point:
- other: 72 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 24 and 72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 48 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h; Scoring not possible beyond 4 h because of conjunctival swelling or corneal opacity.
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 48 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h; Scoring not possible beyond 4 h because of conjunctival swelling or corneal opacity.
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 24 and 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 72 h
- Score:
- 1.2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 24 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- - 10 mg
- Time point:
- other: 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Refer to Attached File 3
- Irritant / corrosive response data:
- The scores for the primary ocular irritation test at dosages of 80 and 10 mg of PTBP are presented in Attached File 2. Instillation of 80 mg PTBP produced severe corneal injury (with vascularization and surface bulges), iritis, and severe conjunctival irritation which persisted through the 21-day postexposure observation period. Similar effects were observed in the group dosed with 10 mg PTBP. Although the severity of the effects in this lower dosage group decreased with time, the signs of irritation and injury again persisted in most eyes for the 21-day post-exposure observation period.
- Other effects:
- Not applicable.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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