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EC number: 202-532-0 | CAS number: 96-76-4
- 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
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- Endpoint summary
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07/02/1991-09/02/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- referenced as Method B5 in Commission Directive 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4-di-tert-butylphenol
- EC Number:
- 202-532-0
- EC Name:
- 2,4-di-tert-butylphenol
- Cas Number:
- 96-76-4
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2,4-di-tert-butylphenol
- Test material form:
- solid
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 Sanbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.90 kg
- Housing: individually housed in a suspended metal cage
- Diet (e.g. ad libitum): ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water (e.g. ad libitum): ad libitum (drinking water)
- Acclimation period: minimum acclimatisation period of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): animal room maintained at 17-20°C
- Humidity (%): relative humidity of 52-57%
- Air changes (per hr): approximately 15 changes/hour
- Photoperiod (hrs dark / hrs light): 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:
- TEST MATERIAL
- Amount applied: 0.1 ml of the test material, which was found to weigh approximately 98 mg (as measured by gently compacting the required volume into and adapted syringe) - Duration of treatment / exposure:
- one second: 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.
- Observation period (in vivo):
- 1 hour, 24 and 48 hours following treatment
- Number of animals or in vitro replicates:
- one
- Details on study design:
- SCORING SYSTEM: Assessment of ocular damage/irritation was made according to the numerical evaluation from 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".
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by the 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
- Time point:
- other: 1, 24, 48 hours
- Score:
- 1 - 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- animal killed after 48h
- Irritation parameter:
- cornea opacity score
- Remarks:
- F: area of opacity
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- animal killed after 48h
- Irritation parameter:
- cornea opacity score
- Remarks:
- (E x F) x 5
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 0 - 40
- Max. score:
- 80
- Irritation parameter:
- iris score
- Remarks:
- D
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks:
- animal killed after 48h
- Irritation parameter:
- iris score
- Remarks:
- D x 5
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 5
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Remarks:
- A: redness
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2 - 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks:
- animal killed after 48h
- Remarks on result:
- other: white areas over nictitating membrane. Sloughing of conjunctival membrane
- Irritation parameter:
- conjunctivae score
- Remarks:
- B: chemosis
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- animal killed after 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- C: discharge
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks:
- animal killed after 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (A + B + C) x 2
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 12 - 14
- Max. score:
- 20
- Irritation parameter:
- overall irritation score
- Remarks:
- Total score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 hours
- Score:
- 17 - 59
- Max. score:
- 110
- Irritant / corrosive response data:
- A dulling of the normal luster of the corneal surface was noted in the treated eye one hour after treatment. Areas of diffuse corneal opacity were noted at the 24-hour observation with areas of grade 4 corneal opacity at the 48-hour observation.
Iridial inflammation was noted in the treated eye at the one, 24 and 48-hour observations.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at 24 and 48-hour observations. White areas over the nictitating membrane were also noted at the 24 and 48-hour observations. Sloughing of the conjunctival membrane was noted in the treated eye at the 48-hour observation.
Due to severe ocular reactions the animal was killed for humane reasons immediately after the 48-hour observation in accordance with Home Office guidelines. No further animals were treated.
Any other information on results incl. tables
Individual scores and total scores for ocular irritation
Rabbit number and sex IPR3 85 Male (bodyweight Kg) (2.90) |
|||
Time after treatment |
1 hour |
24 hours |
48 hours |
CORNEA |
|||
E = degree of opacity |
d |
1 |
2 |
F = area of opacity |
4 |
4 |
4 |
Score (E x F) x 5 |
0 |
20 |
40 |
IRIS |
|||
D |
1 |
1 |
1 |
Score (D x 5) |
5 |
5 |
5 |
CONJUNCTIVAE |
|||
A = redness |
2 |
2 W |
3 SlW |
B = chemosis |
2 |
2 |
2 |
2 = discharge |
2 |
2 |
2 |
Score (A + B + C) x 2 |
12 |
12 |
14 |
Total score |
17 |
37 |
59 |
IPR = initial pain reaction
Sl = sloughing of conjunctival membrane
d = dulling of the normal lustre of the corneal surface
W = white areas over nictitating membrane
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test material, DTBP, produced a maximum total score of 59 and was considered to be at least a severe irritant (class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and calandra classification system (based on one rabbit only).
The test material produced positive criteria in the treated rabbit according to the EEC labelling regulations and was considered to be irritant to the rabbit eye. - Executive summary:
A study was performed to assess the irritancy potential of the test material, DTBP, 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 one rabbit produced areas of grade 4 corneal opacity, iridial inflammation and moderate conjunctival irritation. Other adverse effects noted were a dulling of the normal lustre of the corneal surface, white areas over nictitating membrane and sloughing of the consjunctival membrane.
The test material, DTBP, produced a maximum total score of 59 and was considered to be at least a severe irritant (class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and calandra classification system (based on one rabbit only).
The test material produced positive criteria in the treated rabbit according to the EEC labelling regulations and was considered to be irritant to the rabbit eye.
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