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EC number: 226-854-6 | CAS number: 5510-99-6
- 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:
- 23/07/1992-30/07/1992
- 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:
- 1 992
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:
- Di-sec-butylphenol, mixed isomers
- EC Number:
- 226-854-6
- EC Name:
- Di-sec-butylphenol, mixed isomers
- Cas Number:
- 5510-99-6
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2,6-bis(butan-2-yl)phenol
- Details on test material:
- Name of test material (as cited in study report): Phenol 2,6-bis(1-methylpropyl)
- Substance type: Di-alkylphenol
- Physical state: dark straw-coloured liquid
- Analytical purity: 98.7% GC
- Purity test date: 04/02/1992
- Lot/batch No.: 20204010
- Expiration date of the lot/batch:
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- EST ANIMALS
- Source: David Percival ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: twekve to sixteen weeks old
- Weight at study initiation: 2.74-3.30 kg
- Housing: individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum (Spillers Rabbit Dite, Dalgety Agriculture Ltd., Almondsbury, Bristol, UK
- Water (e.g. ad libitum): ad libitum (drinking water)
- Acclimation period: a minimum acclimatisation period of five days.
Each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C. On occassions the temperature was above the limit specified in the protocol (23°C). This was considered not to have affected the purpose or integrity of the study.
- Humidity (%): 55-67%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test material was instilled 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. The left eye remain untreated and was used for control purposes. 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 falicitated by use of the light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- 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
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0 - 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (D x 5)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: (D x 5)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0 - 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: (D x 5)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0 - 12
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: (A + B + C) x 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0 - 6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: (A + B + C) x 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0 - 8
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (A + B + C) x 2
- Irritant / corrosive response data:
- No adverse corneal effects were oberved during the study.
Iridial inflammation was noted in two treated eyes one hour after treatment and in one treated eye at the 24-hour observation. No other adverse iridial effects were noted.
Minimal to moderate conjunctival irritation was noted an all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. Minimal conjunctival irritation was noted in one treated eye at the 48-hour observation. Hemorrhage of the nictitating membrane was also noted in one treated eye one and 24 hours after treatment.
Treated eyes appeared normal 24, 48 or 72 hours after treatment.
Any other information on results incl. tables
Individual scores and individual total scores for ocular irritation
Rabbit number and sex (bodyweight Kg) |
IPR = 3
68 Female (3.06) |
IPR = 0 + 25 Female (2.74) |
IPR = 0 + 73 Male (3.30) |
|||||||||
Time after treatment |
1 hr |
24 hr |
48 hr |
72 hr |
1 hr |
24 hr |
48 hr |
72 hr |
1 hr |
24 hr |
48 hr |
72 hr |
CORNEA |
||||||||||||
E = degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = area of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
||||||||||||
D |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (D x 5) |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
CONJUNCTIVAE |
||||||||||||
A = redness |
2 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
2H |
1H |
0 |
0 |
B = chemosis |
2 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
2 = discharge |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
12 |
8 |
4 |
0 |
6 |
0 |
0 |
0 |
8 |
4 |
0 |
0 |
Total score |
17 |
13 |
4 |
0 |
6 |
0 |
0 |
0 |
13 |
4 |
0 |
0 |
hr = hour(s)
IPR = initial pain reaction
H = haemorrhage of the nictitating membrane
+ = one drop of ophthaine instilled into each eye 1 -2 minutes before dosing
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 |
|
68 Female |
17 |
13 |
4 |
0 |
25 Female |
6 |
0 |
0 |
0 |
73 Male |
13 |
4 |
0 |
0 |
Group total |
36 |
17 |
4 |
0 |
Group mean score |
12.0 1 hr |
5.7 24 hr |
1.3 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 |
68 Female (3.06) |
24 hr |
0 |
1 |
2 |
2 |
48 hr |
0 |
0 |
1 |
1 |
|
72 hr |
0 |
0 |
0 |
0 |
|
Total |
|
0 |
1 |
3 |
3 |
Mean |
|
0.0 |
0.3 |
1.0 |
1.0 |
25 Female (2.74) |
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 |
73 Male (3.30) |
24 hr |
0 |
0 |
1 |
1 |
48 hr |
0 |
0 |
0 |
0 |
|
72 hr |
0 |
0 |
0 |
0 |
|
Total |
|
0 |
0 |
1 |
1 |
Mean |
|
0.0 |
0.0 |
0.3 |
0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as non-irritant 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 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 91/325/EEC).
A single instillation of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and/or minimal to moderate conjunctival irritation. Haemorrhage of the nictitating membrane was noted in one treated eye one and 24 hours after treatment. Treated eyes appeared normal 24, 48 or 72 hours after treatment.
The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (class 4 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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