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EC number: 500-687-1 | CAS number: 162303-51-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- October 23, 1978 - January 12, 1979
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study pre-dates GLP and performed according to a non-guideline method. Insufficient data is provided on study methods and results.
- 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 the particular alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for toxicokinetics of the target substance. Because of the rapid hydrolysis the influence of the mode of administration through inhalation, dermal and/or oral is related to the most hazardous degradation product (alcohol) released from the substance. The testing conducted with analogue substances of the category proves that the toxicity is similar to the toxicity of alcohol released from the target substance in contact with moisture. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance which might change the toxicity of the target substance compared to the toxicity of the pure alcohol. 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. In addition, the test results of analogue category members releasing same alcohols are used to evaluate the short term and long-term toxicity, skin and eye irritation and sensitization, and mutagenic properties of the target substance.
Cross-reference
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- October 23, 1978 - January 12, 1979
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study pre-dates GLP and performed according to a non-guideline method. Insufficient data is provided on study methods and results.
- 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 the particular alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for toxicokinetics of the target substance. Because of the rapid hydrolysis the influence of the mode of administration through inhalation, dermal and/or oral is related to the most hazardous degradation product (alcohol) released from the substance. The testing conducted with analogue substances of the category proves that the toxicity is similar to the toxicity of alcohol released from the target substance in contact with moisture. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance which might change the toxicity of the target substance compared to the toxicity of the pure alcohol. 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. In addition, the test results of analogue category members releasing same alcohols are used to evaluate the short term and long-term toxicity, skin and eye irritation and sensitization, and mutagenic properties of the target substance.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- One drop (~0,05ml) 5% and 50% solution (vol/vol) of the test material in acetone was applied on shaved, shoulder intact skin of 10 guinea pigs. Skin reaction was observed and recorded at 24h and at 48h after test material application.
- GLP compliance:
- no
- Species:
- guinea pig
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 480g - Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- other: acetone
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: One drop (~0,05ml)
- Concentration (if solution): 5% and 50% (vol/vol)
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 24 hours and 48 hours
- Observation period:
- At 24 hours and 48 hours after test material application skin reactions were recorded
- Number of animals:
- 10 animals
- Details on study design:
- TEST SITE
-shoulder skin of the animal
REMOVAL OF TEST SUBSTANCE
-washing of the test substance was not done
SCORING SYSTEM:
+ mild erythema
++ moderate erythema
+++ strong erythema
++++ erythema plus edema
+++++ necrosis - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- other:
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- other:
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Titanic acid, tetrabutyl ester caused moderate to no irritation when tested as a 50% suspension in acetone on the shaved, intact skin of guinea pigs and mild to no irritation when tested as a 5% suspension.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The primary dermal irritation potential of titanium tetrabutanolate was evaluated when applied to the skin of guinea pigs for 24 hour and for 48 hour. The test substance is considered to be mild skin irritant according to this study.
- Executive summary:
Titanium tetrabutanolate was applied in two concentrations (5% and 50% vol/vol in acetone) to two separate test areas on the intact skin on each animal´s back. By the study report the test material is considered to be mild irritant to the skin of guinea pigs.
This study was regarded not reliable since the study pre-dates GLP and it is non-guideline study. Furthermore, the study report includes insufficient details on study methods and results. This study does not satisfy the guideline requirements for the skin irritation study.
This toxicity study from this analogue category member (Titanium tetrabutanolate) is used for the weight of evidence to justify that the skin irritation of Tetra-n-butyl titanate, polymer with water. Skin irritation result from organometallic category member Titanium tetrabutanolate is justified.
The result of this study is used as a weight of evidence in hazard assessment.
Reactions on intact guinea pig skin
|
Test group (10 animals) |
Test group (10 animals) |
Concentration in acetone |
50% |
5% |
Primary irritation test - 24 hours |
1+, 9 negative |
1+, 9 negative |
Primary irritation test - 48 hours |
1 +, 9 negative |
1+, 9 negative |
Reaction codes are as follows: + mild erythema ++moderate erythema +++ strong erythema ++++ erythema plus oedema +++++necrosis
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- One drop (~0,05ml) 5% and 50% solution (vol/vol) of the test material in acetone was applied on shaved, shoulder intact skin of 10 guinea pigs. Skin reaction was observed and recorded at 24h and at 48h after test material application.
- 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 No 12,678
- Substance type: organometallic
- Physical state: liquid
- Analytical purity: 95%
- Lot/batch No.: 12,678
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 480g
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- other: acetone
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: One drop (~0,05ml)
- Concentration (if solution): 5% and 50% (vol/vol)
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 24 hours and 48 hours
- Observation period:
- At 24 hours and 48 hours after test material application skin reactions were recorded
- Number of animals:
- 10 animals
- Details on study design:
- TEST SITE
-shoulder skin of the animal
REMOVAL OF TEST SUBSTANCE
-washing of the test substance was not done
SCORING SYSTEM:
+ mild erythema
++ moderate erythema
+++ strong erythema
++++ erythema plus edema
+++++ necrosis
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- other:
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- other:
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 6
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Titanic acid, tetrabutyl ester caused moderate to no irritation when tested as a 50% suspension in acetone on the shaved, intact skin of guinea pigs and mild to no irritation when tested as a 5% suspension.
Any other information on results incl. tables
Reactions on intact guinea pig skin
|
Test group (10 animals) |
Test group (10 animals) |
Concentration in acetone |
50% |
5% |
Primary irritation test - 24 hours |
1+, 9 negative |
1+, 9 negative |
Primary irritation test - 48 hours |
1 +, 9 negative |
1+, 9 negative |
Reaction codes are as follows: + mild erythema ++moderate erythema +++ strong erythema ++++ erythema plus oedema +++++necrosis
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The primary dermal irritation potential of titanium tetrabutanolate was evaluated when applied to the skin of guinea pigs for 24 hour and for 48 hour. The test substance is considered to be mild skin irritant according to this study.
- Executive summary:
Titanium tetrabutanolate was applied in two concentrations (5% and 50% vol/vol in acetone) to two separate test areas on the intact skin on each animal´s back. By the study report the test material is considered to be mild irritant to the skin of guinea pigs.
This study was regarded not reliable since the study pre-dates GLP and it is non-guideline study. Furthermore, the study report includes insufficient details on study methods and results. This study does not satisfy the guideline requirements for the skin irritation study.
This toxicity study from this analogue category member (Titanium tetrabutanolate) is used for the weight of evidence to justify that the skin irritation of Tetra-n-butyl titanate, polymer with water. Skin irritation result from organometallic category member Titanium tetrabutanolate is justified.
The result of this study is used as a weight of evidence in hazard assessment.
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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