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EC number: 281-161-6 | CAS number: 83877-91-2
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- October 23, 1978 - December 22, 1978
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: This study predates current guideline and the study report does not include details on test substance, test animals and test procedure.
- Justification for type of information:
- The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than alcohols, ethyl acetoacetate and hydrated titanium dioxide. Because of the rapid hydrolysis, the influence of the mode of administration through inhalation, dermal and oral is related to the organic degradation products released from the substance. Based on the toxicological properties of these degradation products the hazard assessment concentrates on the most hazardous degradation product (alcohols). The testing conducted with analogue substances of the category (category 1 and 2) proves that the toxicity is similar to the toxicity of alcohol released when the target substance comes in contact with moisture. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities released from the target substance which might change the toxicity of the target substance compared to the toxicity of the pure alcohol or ethyl acetoacetate. The read-across approach from analogue category members are used to justify that the mode of administration through oral, inhalation and/or dermal is similar to the adverse effects of the degradation products and therefore the read-across from the most hazardous degradation products can be used to evaluate the toxicological effects of the target substance. In addition, as all the titanates in category 1 and 2 have similar hydrolyzing behavior, the test results of analogue category members releasing same alcohols can be used to read-across the short-term and long-term toxicity, skin and eye irritation, sensitization, and genotoxicity of the target substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.1 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 tap 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, three, seven, fourteen and twenty-one days.
- GLP compliance:
- no
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 tetrakis(butan-1-olato)
- Details on test material:
- - Name of test material (as cited in study report): Titanic acid, tetrabutyl ester; Haskell Number 12,678
- Substance type: organometal
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Rabbits were described albino rabbits. There were no details on environmental conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Test substance was placed into the right conjunctival sac. Observations were made at 1, 4, 24, 48, 72 hours, and at days 7, 14, and/or 21.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 24
- Details on study design:
- 0.1 ml test substance was placed into the right conjunctival sac. Total of 2 animals were treated. After 20 seconds treated eye of the one rabbit was washed with tap water for one minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris and conjunctiva were made with hand-slit lamp at 1, 4, 24, 48, 72 hours, and at days 7, 14, and 21. Fluor-i-strip stain and a biomicroscope were used at examinations after the day of treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis 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:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
Any other information on results incl. tables
Animal/treatment |
Cornea |
Iris |
Conjunctiva |
0.1 ml undiluted liquid, Eye not washed |
Cornea not seen 1 -4 hrs. due to conjunctival swelling. Generalized moderate opacity with severe corneal swelling 1 -14 days. Moderate area of moderate opacity with moderate to severe swelling at 21 days. |
Iris not seen 1 -4 hrs. due to conjunctival swelling. Moderate to severe irritis with a flare 1 -3 days; moderate at 7 days; slight injection at 14 days. |
Redness: Severe 1 hr.-7 days with blanching at 1 hr. - 1 day; moderate at 14 days. Swelling:. Severe 1 - 4hrs.; moderate 1 -4 days; mild at 7 days; slight at 14 days Discharge: Copious Hemastix -Positive 1hr-2 days; moderate Hemastix-Positive at 3 days; mild at 7 days |
0.1 ml undiluted liquid, Eye washed after 20 seconds |
Generalized mild opacity 1 hr.-3 days with severe corneal swelling 1 -2 days and moderate to severe swelling at 3 days; Moderate area of slight opacity with mild to moderate swelling at 7 days; Small area of slight opacity with mild corneal swelling 14 -21 days |
Moderate iritis 1hr.-3 days with a flare 1 -2 days |
Redness: Severe 1 hr-3 days with blanching at 1 hr-1 day. Swelling: Moderate at 1 hr.; moderate to severe at 4hrs.; moderate 1 -2 days; mild at 3 days Discharge: Copious Hemastix-Positive 1 hr.-1 day; moderate at 2 days; mild at 3 days |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- 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. The test material caused persistent lesions which were not fully reversible within an observation period of 21 days and is thus classified in Category 1 eye irritant by the applicant.
- Executive summary:
Titanium tetrabutanolate was applied undiluted into the eyes of two rabbits. After 20 seconds, treated eye of one rabbit was washed with water. The treated eye of the other rabbit was not washed. Observations were made at 1 and 4 hours, and at 1, 2, 3, 7, 14, and 21 days for the treated eyes. Titanium tetrabutanolate severely irritated the cornea and conjunctiva and moderately to severily irritated the iris of both the washed and unwashed rabbit eyes. At 21 days, the unwashed eye had moderate to severe corneal irritation and the washed eye had mild corneal irritation.
This study was regarded as non reliable, since the study report does not include details on test material and test procedure. Furthermore, tabulation of irritant/corrosive response data for each animal at each observation time point is missing.
This study does not satisfy the guideline requirements for the eye irritation study and thus the result of this study is used as a supporting evidence for hazard assessment
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