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EC number: 947-623-2 | 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:
- March - April 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 405 guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
- EC Number:
- 915-333-5
- IUPAC Name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
Constituent 1
- Specific details on test material used for the study:
- Of note, in the absence of specific data on the registered Reaction mass of o-(1-phenylethyl) phenol and bis(1-phenylethyl) phenol and 2,4,6-tris(1-phenylethyl)phenol and the obligation to generate some data for intermediates, data from the Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol have been included in the dossier by default as comparable hazard profile could be expected between both substances.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conelli S.n.c., Via Milano 61, 28341 Arona (Novara) Italy
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 2.5 to 2.8 kg
- Housing: in 62 x 47.5 x 38 cm metal cages with stainless steel feeders
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Yes (exact duration not specified)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50 +/- 15
- Air changes (per hr): approximately 20/hour
- Photoperiod (hrs dark / hrs light): 12 / 12 (7 a.m. / 7 p.m.)
IN-LIFE DATES: From: March 11, 1997 To: March 14, 1997
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): Not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- Single instillation in the conjunctival sac of the right eye (lids gently held together for 3 to 4 seconds)
- Observation period (in vivo):
- 1, 24, 48 and 78 hours after instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: sterile saline
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Ocular reaction was scored using the following scale (adapted from Draize, according to US Consumer Product Safety Commission guide) :
- Corneal opacity (maximum possible 4):
0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacrous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity
- Iris (maximum possible 2):
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperhemia, or injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)
- Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris, maximum possible 3):
0 = Blood vessels normal
1 = Some blood vessels definitely hyperhemic (injected)
2 = Diffuse, crimson color, individual vessels not easily discernible
3 = Diffuse beefy red
Chemosis (lids and/or nictitating membranes, maximum possible 4):
0 = No swelling
1 = Any swelling above normal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed
Ocular irritation was evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.
TOOL USED TO ASSESS SCORE:
Fluorescein (one drop of 1% sodium fluorescein) was instilled following reading at 24 hours, and subsequently washed out with sterile saline, for detection of corneal epithelium abnormalities.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours of application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below
- Other effects:
- No other effects were observed.
Noticeably, negative results were obtained at fluorescein staining 24 hours after instillation of the test substance.
Any other information on results incl. tables
Animal number | 1 | 2 | 3 | |
Cornea: opacity | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Iris: iritis | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Conjunctivae: redness | 1 h | 1 | 2 | 1 |
24 h | 0 | 1 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Conjunctivae: chemosis | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Slight or moderate conjunctival redness was observed in all three animals 1 hour following instillation of 0.1 mL of test substance. This finding was fully reversible within 24 to 48 h of instillation. Therefore, the test item was considered as non irritant and not classified for eye irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.
- Executive summary:
In a primary eye irritation study (RBM study No. 970074), 0.1 mL of Tristyrenated phenol/Distyrenated phenol (75/25 molar %) were instilled into the conjunctival sac of the right eye of three male New Zealand White rabbits (2- to 3-month old). A washout was performed using sterile saline 24 hours after instillation. Local changes of cornea, iris and conjunctivae were observed 1, 24, 48 and 72 h after instillation. Fluorescein examination was also performed 24 hours after instillation. Irritation was scored by the method of US Consumer Product Safety Commission, adapted from Draize, taking account of potential corneal opacity, iritis, and conjunctival redness or chemosis.
Slight or moderate conjunctival redness (grade 1 or 2) was observed in all three animals 1 hour following instillation of the test substance. Slight redness (grade 1) was still observed 24 hours after instillation in the most severely affected animal. Conjunctival redness was fully reversible within 24 to 48 hours of instillation. Therefore, the test item was considered as non irritant to the eye.
In this study, Tristyrenated phenol/Distyrenated phenol (75/25 molar %) is not an eye irritant based on the low severity and complete reversibility of local changes following conjunctival instillation of 0.1 mL.
TSP/DSP is not classified for eye irritation according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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