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EC number: 700-641-2 | CAS number: 1261240-30-5
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- EC Number:
- 700-641-2
- Cas Number:
- 1261240-30-5
- Molecular formula:
- C37H46O5
- IUPAC Name:
- 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- Test material form:
- other: Crystalline powder
- Details on test material:
- Name: Revonox 501
Lot/Batch No.: S25211603
Major ingredients: 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl3,5-di-tert-butyl-4-hydroxybenzoate
Purity of active ingredients: 99-100% min
Physical feature: No sterilization, white crystalline powder, no odour
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Source: Hui-Jun Grazing
Quality: Clean Conventional
Gender: Male
Justification for selection: The NZW rabbit is widely used and accepted by Health Authorities as an appropriateexperimental animal.
Age and body weight: At study initiation, animals were approximately 5 months old, with the study weights range of 2.3 - 2.7 kg prior to dosing.
Animal amount: 3 male rabbits
ENVIRONMENTAL CONDITIONS
Temperature: 20+/-3 degree C
Relative humidity: 50+/-20%
Light cycle: 12 hours light and 12 hours dark
Diet: Labdiet, Prolab Rabbit Diet 5P26 was supplied approximately 50 g/kg daily throughout the study period.
Water: RO water was supplied ad libitum via water bottles attached to the cages.
Rabbits were housed in stainless steel cages (One rabbit/cage).
Test system
- Vehicle:
- not specified
- Controls:
- other: Untreated left eye was used as control.
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- INITIAL TEST
Animal amount: 1; Control (untreated): Left eye; Test substance treated: Right eye
CONFIRMATORY TEST
Animal amount: 2; Contraol (untreated): Left eye; Test substance treated: Right eye
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (Animal I.D. A111100311001)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No conjunctivae redness effect was observed during the study.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (Animal I.D. A111100311002)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No conjunctivae redness effect was observed during the study.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (Animal I.D. A111100311003)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No conjunctivae redness effect was observed during the study.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (Animal I.D. A111100311001)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (Animal I.D. A111100311002)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (Animal I.D. A111100311003)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (Animal I.D. A111100311001)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No corneal effect was observed during the study.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (Animal I.D. A111100311002)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks:
- The reversibility was noted at 24 hours after treatment. No corneal redness effect was observed during the study.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (Animal I.D. A111100311003)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No corneal effect was observed during the study.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (Animal I.D. A111100311001)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No iridial effect was observed during the study.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (Animal I.D. A111100311002)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No iridial effect was observed during the study.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (Animal I.D. A111100311003)
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: The reversibility was noted at 24 hours after treatment. No iridial effect was observed during the study.
Any other information on results incl. tables
Mortality/Moribundity: No animal death was observed during the study period.
CLinical Observation: No abnormal clinical signs were observed during the observation period.
Individual Animal Body Weights: Individual animal body weights were recorded on the Day 1 (before dosing) and at the end of the observation period (Day 4). The body weights of rabbits were no abnormal decrease noted during the study period.
Individual Animal Ocular Irritation Evaluation
A. Initial test
No corneal, iridial or conjunctivae redness effects were noted during the observation period. THe testing animal was noted minimal conjunctival swelling in test substance treated eye at one hour after treatment. The conjunctival chemosis was observed normal at 24, 48 and 72 hours after treatment.
B. Confirmatory test
No corneal, iridial or conjunctivae redness effects were noted in the two additional testing animals during the observation period. The testing animals were noted minimal conjunctival swelling in test substance treated eye at one hour after treatment. The conjunctival chemosis was observed normal at 24, 48 and 72 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the conditions and results of the study, test substance administered to NZW rabbits by ocular instillation only caused minimal conjunctival swelling at one hour after instillation. The reversibility was noted at 24 hours after instillation. No corneal, iridial or conjunctivae redness effects were observed during the observation period. No corrosive or severe irritant effects were observed during the study. All data generated from this study will provide as safety reference for human exposure.
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