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EC number: 213-969-1 | CAS number: 1070-10-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 23, 1978 - January 12, 1979
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study that predates current guideline. There is no positive control and no use of Freund's complete adjuvant.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- Two days after the primary irritation test (see chapter 7.3.1 Skin irritation/corrosion.weight_of_evidence.001), induction phase for sensitisation test was started. A series of four intradermal injections of 0.1ml of a 1% test substance solution in acetone/dimethyl phthalate (DMP) 1:9 was given to ten guinea pigs, one each week over three-week period. Following two-week rest period, the test animals were challenged for sensitization by applying 0.05ml of a 50% and 5% suspension of test material in DMP on shaved shoulder skin. At the same time a control group of 10 previously unexposed guinea pigs received similair applications to provide a direct comparison of the challenge reactions.
The skin at the challenge site was evaluated for irritation at 24 and 48 hours after application. Sensitization was defined as a significant score increase at challenge over the response expected from the same amount applied initially or on the concurrent controls. - GLP compliance:
- not specified
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- Provided study is a non-GLP study that predates current guidelines and requirements.
Test material
- Reference substance name:
- Titanium tetrakis(2-ethylhexanolate)
- EC Number:
- 213-969-1
- EC Name:
- Titanium tetrakis(2-ethylhexanolate)
- Cas Number:
- 1070-10-6
- Molecular formula:
- C32H68O4Ti
- IUPAC Name:
- titanium(4+) tetrakis(2-ethylhexan-1-olate)
- Details on test material:
- Titanic Acid, tetrakis(2-ethylhexyl) ester
Tyzor TOT Haskell No. 12,676
Purity 95%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Details on test animals and environmental conditions:
- Albino guinea pigs were used. Initial average weight of animals was 451g and final average weight was 696g. No details on environmental conditions were reported.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: acetone/dimethyl phthalate
- Concentration / amount:
- 1.0%
- Day(s)/duration:
- At weekly intervals for 4 weeks.
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- other: dimethyl phthalate
- Concentration / amount:
- 50% or 5%
- Day(s)/duration:
- Following a 2 week rest period after the last induction treatment.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: a skin irritation study was initially conducted (this is reported in IUCLID chapter 7.3.1).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 4 weeks
- Test groups: 10 per group
- Control group: 10 animals
- Site: intradermal
- Frequency of applications: at weekly intervals
- Duration: for 4 weeks
- Concentrations: 1.0% in acetone/ dimethyl phthalate
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: following a 2 week rest period after the last induction treatment
- Exposure period: test item was lightly rubbed into skin. No information was supplied regarding duration of exposure.
- Test groups: 2
- Control group: yes
- Site: shoulder skin
- Concentrations: 50% and 5% in dimethyl phthalate
- Evaluation (hr after challenge): 24 and 48 hours
CONTROLS
At the challenge test, 10 unexposed guinea pigs of the same age received identical topical applications to the 50% and 5% test item groups. Therefore these animals had not been treated during the induction phase but were similarly treated during the challenge phase. - Challenge controls:
- 10 animals at 50% and 10 animals at 5% test item in vehicle.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in vehicle
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- 2++, 6+, 2 negative for sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in vehicle
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- 3+, 7 negative for sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% in vehicle
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 1++,9+, 0 negative for sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in vehicle
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- 2+, 8 negative for sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 50% in vehicle
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- 7+, 3 negative for sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 5% in vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1+, 9 negative for sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control for 50%
- Dose level:
- 50% in vehicle
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- 7+, 3 negative for sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control for 5%
- Dose level:
- 5% in vehicle
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1+, 9 negative for irritation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The potential sensitisation properties of titanium tetrakis(2-ethylhexanolate) were tested using primary sensitization test on guinea pigs. Based on the study results test substance is considered as not skin sensitizer. No guideline was followed in this study.
- Executive summary:
The test substance was administrated 1% solution (vol/vol) in acetone/DMP 1:9 in a series of four sacral intradermal injections (10 animals). At the time of challenge 0.05ml 5% and 50% test substance (vol/vol) in DMP was applied and lightly rubbed to the shaved intact shoulder skin. A control group of 10 previously unexposed guinea pigs received similair applications at the same time to provide a direct comparison of the challenge reactions. At challenge no sensitization response was observed.
This study was regarded not reliable since the study report contains insufficient details on study methods and results. This study does not satisfy the guideline requirements for the sensitization study, but the result is used as a weight of evidence in hazard assessment.
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