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EC number: 817-187-7 | CAS number: 1803088-15-4
- 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:
- 2016-06-08 to 2016-09-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan/MAFF 8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one
- EC Number:
- 817-187-7
- Cas Number:
- 1803088-15-4
- Molecular formula:
- C54 H73 O5 P
- IUPAC Name:
- 5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one
- Details on test material:
- - State of aggregation: Solid / white
- Storage Condition: room temperature under light exclusion
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; under light exclusion ; no direct sunlight
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: approx. 3 months
- Weight at study initiation: 2.49 - 2.81 kg
- Housing: individual housing
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: approx. 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (about 17 mg of the comminuted test item)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- approx. 1, 24, 48, 72 and 96 h after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: 24 h
SCORING SYSTEM: according to guidelines and, in addition, evaluations were made of discharge from the eye and the area of cornea affected by the lesions:
Area of cornea involved (ar) Grading:
1 > 0 ≤ ¼
2 > ¼ < ½
3 > ½ < ¾
4 > ¾
Discharge (di) Grading:
0 No discharge
1 Slight: any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Obvious: discharge with moistening of the lids and hairs just adjacent to lids
3 Severe: discharge with moistening of the lids and hairs, and considerable area around the eye
TOOL USED TO ASSESS SCORE: hand-slit lamp, otoscope lamp and fluorescein
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
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours. Moderate iritis (grade 1) was observed in one animal 1 hour after application only. Slight conjunctival redness (grade1) was noted in all animals from 1 hour until hour 24 after application. Slight conjunctival chemosis (grade 1) was noted in two animals 1 hour after application. Additional findings like injected scleral vessels in a circumscribed or circular area were noted within 48 hours after application. The ocular reactions were reversible in all animals within 48 hours after application.
- Other effects:
- - Lesions and clinical observations: none
- Ophthalmoscopic findings: none
- Histopathological findings: not performed
- Effects of rinsing or washing: none
Any other information on results incl. tables
Table 1. Irritant response, data for each
individual animal at each observation time as well as calculation of the
mean
|
Cornea |
Iris |
Conjunctiva |
||||
Readings |
Animal No. |
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
|
1 h
|
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
0 |
|
3 |
0 |
0 |
0 |
1 |
1 |
0 |
|
24 h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
3 |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean 24 h- 72h |
1 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
2 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
|
3 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
|
Mean |
- |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, the test item does not show an eye irritating potential under the test conditions chosen.
- Executive summary:
The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 17 mg) of the undiluted test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 and 96 hours after application. Additional eye examinations were performed at 24 and 48 h after application with the instillation of a fluorescein solution. Due to absence of detectable lesions following fluorescein instillation, all subsequent readings were performed without the aid of fluorescein. No corneal lesions were noted in any animal at any examination time point. Even after instillation of a fluorescein solution no corneal lesions were detectable after 24 and 48 hours. The following test item-related clinical observations were recorded during the course of the study: Moderate iritis (grade 1), slight conjunctival redness (grade 1) and slight conjunctival chemosis (grade 1). Additional findings like injected scleral vessels in a circumscribed or circular area were noted in the animals within the first 48 hours. The ocular reactions were reversible in all animals within 48 hours after application. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity and for iris lesions, 0.3, 0.3 and 0.3 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test article does not show an eye irritating potential under the test conditions chosen.
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