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EC number: 227-006-8 | CAS number: 5593-70-4
- 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
- Remarks:
- no data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 3, 1984 - October 6, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP and non-giudeline study, but the method and results are well documented and scientfically acceptable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.01 ml of the undiluted test substance was placed into the right conjunctival sac of two albino rabbit. After 20 seconds treated eye was washed with 25% propylene glycol in distilled water for one minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris and conjunctiva were made at one and four hours, and at one, two and three days.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Titanium tetrabutanolate
- EC Number:
- 227-006-8
- EC Name:
- Titanium tetrabutanolate
- Cas Number:
- 5593-70-4
- Molecular formula:
- C16H36O4Ti
- IUPAC Name:
- titanium(4+) tetrakis(butan-1-olate)
- Details on test material:
- - Name of test material (as cited in study report): 1-Butanol, titanium (4+) Salt, Haskell No. 15,538. Other codes: TLF-6171, lot 1
- Composition of test material, percentage of components: 25% titanium tetrabutanolate
75% kerosene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutcland Inc., Denver, Pennsylvania
- Housing: individually in elevated wire-mesh cages
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow #5321 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimun of seven days
IN-LIFE DATES: From: To: All surviving rabbits were sacrificed at 72 hours postinstillation
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.01 ml
- Duration of treatment / exposure:
- Test material was placed into right conjunctival sac in each of 2 rabbits. After 20 seconds the eye of one rabbit was washed for 1 minute with 25% propylene glycol in distilled water. The second was dosed in a similar manner, but no washing was performed. Observations were made up to day 72 hours.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 (one male/one female)
- Details on study design:
- 0.01 ml of undiluted test material was placed into the right conjunctival sac of each of 2 rabbits. After 20 seconds, 1 treated eye was washed with a 25% propylene glycol/water solution to see if effects after washing with this solution were less than with water. The treated eye of the other rabbit was not washed. Ophthalmoscopic examinations of the cornea, iris and conjunctiva were made at 1, 4, 24, 48 and 72 hours. Fluorescein staining of right eye was peformed at 24, 48 and 72 hour time points for corneal defects.
At termination (72 hours postinstillation), all surviving rabbits were sacrificed with T-61 Euthanasia solution (Taylor Pharma Company, Dacatur, Illinois) and discarded without necropsy.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72h
Any other information on results incl. tables
Test material caused conjunctival irritation (redness, grade 2) in the washed eye at 1 and 4 hours but subsided to grade 1 at 24 and 48 hours. Chemosis (grade 1) was noted in the unwashed and washed eyes at 1 and 4 hours. A discharge (grade 1) was observed in both the unwashed and washed eye at 1 and 4 hours only. No opacity or iritis was observed in either eye at any observation interval throughout the study. Fluorescein and ophthalmoscopic examinations were negative in both eyes at all observation periods.
Rabbit No E36664 | Observation intervals | ||||
unwashed eye (male) | 1h | 4h | 24h | 48h | 72h |
Cornea | |||||
Opacity | 0 | 0 | 0 | 0 | 0 |
Area involved | 0 | 0 | 0 | 0 | 0 |
Subtotal | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 |
Subtotal | 0 | 0 | 0 | 0 | 0 |
Conjunctivae | |||||
Redness | 1 | 1 | 0 | 0 | 0 |
Chemosis | 1 | 1 | 0 | 0 | 0 |
Discharge | 1 | 1 | 0 | 0 | 0 |
Subtotal | 6 | 6 | 0 | 0 | 0 |
Total Score | 6 | 6 | 0 | 0 | 0 |
Rabbit No E36705 | Observation intervals | ||||
washed eye (female) | 1h | 4h | 24h | 48h | 72h |
Cornea | |||||
Opacity | 0 | 0 | 0 | 0 | 0 |
Area involved | 0 | 0 | 0 | 0 | 0 |
Subtotal | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 |
Subtotal | 0 | 0 | 0 | 0 | 0 |
Conjunctivae | |||||
Redness | 2 | 2 | 1 | 1 | 0 |
Chemosis | 1 | 1 | 0 | 0 | 0 |
Discharge | 1 | 1 | 0 | 0 | 0 |
Subtotal | 8 | 8 | 2 | 2 | 0 |
Total Score | 8 | 8 | 2 | 2 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The eye irritation potential of titanium tetrabutanolate was evaluated when introduced to the eyes of rabbits. According to the study report, the test material was considered a eye irritant.
- Executive summary:
Test material was applied undiluted into the eyes of two rabbits. After 20 seconds, treated eye of one rabbit was washed with 25% propylene glycol in water. The treated eye of the other rabbit was not washed. Observations were made at 1, 4, 24, 48 and 72 hours . Test material caused conjunctival irritation (redness, grade 2) in the washed eye at 1 and 4 hours but subsided to grade 1 at 24 and 48 hours. Chemosis (grade 1) was noted in the unwashed and washed eyes at 1 and 4 hours. A discharge (grade 1) was observed in both the unwashed and washed eye at 1 and 4 hours only. No opacity or iritis was observed in either eye at any observation interval throughout the study. Fluorescein and ophthalmoscopic examinations were negative in both eyes at all observation periods.
This study was regarded reliable with restrictions. Though, this study is non-GLP and non-giudeline study, the method and results are well documented and scientifically acceptable. Thus, this study is used as a key study for hazard assessment.
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