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EC number: 204-884-0 | CAS number: 128-39-2
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6-di-tert-butylphenol
- EC Number:
- 204-884-0
- EC Name:
- 2,6-di-tert-butylphenol
- Cas Number:
- 128-39-2
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2,6-di-tert-butylphenol
- Details on test material:
- - Name of test material (as cited in study report): Phenol, 2,6-bis(1,1-dimethylethyl)
- Substance type: di-alkylphenol
- Physical state: white crystalline solid
- Analytical purity: 99.26% (GC)
- Purity test date: 03/10/1990
- Lot/batch No.: 2,6-AP/308
- Storage condition of test material: in original container at room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.64-3.14 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet: ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water: ad libitum, drinking water
- Acclimation period:minimum acclimatisation period of five days
Immediately before the start of the test, both eyes of the three provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.
ENVIRONMENTAL CONDITIONS
- Temperature: the animal room was maintained at 18-20°C
- Humidity: 49-61%
- Air changes: approximately 15 changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approximately 67 mg (as measured by gently compacting the required volume into an adapted syringe
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. Immediately after administration of the test material, an assessment of the initial pain reaction was made.
SCORING SYSTEM: Assessment of ocular damage/irritation was made according to the numerical evaluation given by Draize J. H. 1959, Association of Food and Drug Officials of the United states, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
Any other adverse ocular effects were also noted.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- E = degree of opacity
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- F = area of opacity
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- A = redness
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0 - 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 2 animals: within 24 hours. 1 animal: within 48 hours
- Irritation parameter:
- chemosis score
- Remarks:
- B = Conjunctivae chemosis
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- C = discharge
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- No adverse corneal or iridial effects were noted during the study.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and in one treated eye at the 24-hour observation.
All treated eyes appeared normal 48 hours after treatment.
Any other information on results incl. tables
Individual total scores and group mean scores for ocular irritation
Rabbit number and sex |
Individual total scores at: |
|||
1 hr |
24 hr |
48 hr |
72 hr |
|
172 Female |
4 |
0 |
0 |
0 |
193 Female |
4 |
0 |
0 |
0 |
154 Male |
6 |
2 |
0 |
0 |
Group total |
14 |
2 |
0 |
0 |
Group mean score |
4.7 1 hr |
0.7 24 hr |
0.0 48 hr |
0.0 72 hr |
Individual & mean scores for cornea, iris & conjunctivae required for EEC labelling regulations
Rabbit number and sex (bodyweight Kg) |
Time after treatment |
Corneal opacity |
Iridial inflammation |
Conjunctival redness |
Conjunctival chemosis |
172 Female (3.14) |
24 hr |
0 |
0 |
0 |
0 |
48 hr |
0 |
0 |
0 |
0 |
|
72 hr |
0 |
0 |
0 |
0 |
|
Total |
|
0 |
0 |
0 |
0 |
Mean |
|
0.0 |
0.0 |
0.0 |
0.0 |
193 Female (2.64) |
24 hr |
0 |
0 |
0 |
0 |
48 hr |
0 |
0 |
0 |
0 |
|
72 hr |
0 |
0 |
0 |
0 |
|
Total |
|
0 |
0 |
0 |
0 |
Mean |
|
0.0 |
0.0 |
0.0 |
0.0 |
154 Male (2.84) |
24 hr |
0 |
0 |
1 |
0 |
48 hr |
0 |
0 |
0 |
0 |
|
72 hr |
0 |
0 |
0 |
0 |
|
Total |
|
0 |
0 |
1 |
0 |
Mean |
|
0.0 |
0.0 |
0.3 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced a maximum group mean score of 4.7 and was classified as a minimal irritant (class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produced positive criteria in any rabbit according to the EEC labelling regulations and was classified as non-orritant to the rabbit eye. No symbol and risk phrase are therefore required. - Executive summary:
A study was performed to assess the irritancy potential of the test material, DTBH, to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 83/467/EEC).
A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal 48 hours after treatment.
The test material produced a maximum group mean score of 4.7 and was classified as a minimal irritant (class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material was also classified as non-irritant according to the EEC labelling regulations. No symbol and risk phrase are required.
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