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EC number: 226-949-2 | CAS number: 5575-43-9
- 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
Endpoint summary
Administrative data
Description of key information
GPMT (OECD 406): Not sensitizing
Sensitisation study (No guideline followed) done for structurally similair substance: Not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Guinea pig maximisation test (GPMT) (OECD 406)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Sept 1989 - 13 Apr 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 12.5.1981
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT study was conduct in 1990 prior recommendation to use LLNA
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Weight at study initiation: 431 g (test group); 454 g (controls)
- Housing: 1-5 animals in Macrolon cages type IV
- Diet (e.g. ad libitum): ad libitum, guinea pig complete diet G4
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 deg C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12TEST ANIMALS - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.1ml 0.5 % test substance
- Day(s)/duration:
- 7 days
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 2
- No. of animals per dose:
- 20 (test item)
10 (control) - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 intradermal and topical
- Test groups: 1
- Control group: 1
- Site: Three pairs of intradermal injections of 0.1 ml volume are given in the shoulder region which is cleared of hair so that one of each pair lies on each side of the midline.
- Frequency of applications: once
- Duration: 7 days
- Concentrations:
Day 0: Intradermal application:
Test animals (20): 0.1 ml mixture (1:1) FCA and H2O ; 0.1 ml 0.5% test substance in corn oil ; 0.1 ml 0.5% test substance in FCA:H2O (1:1).
Control animals (10): 0.1 ml mixture (1:1) FCA and H2O ; 0.1 ml corn oil ; 0.1 ml FCA:H2O (1:1).
Day 7: Topical application:
Test group: A filter paper (2 x 4 cm) was fully-loaded with test substance applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control animals: Corn oil was applied in the similair manner
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 7 & 21
- Exposure period: 2 days
- Test groups: 1
- Control group: 1
- Concentrations: All animals: A patch loaded with the test substance is applied to one flank of the animals and a patch with the vehicle only was applied to the other flank. The patches are held in contact by an occlusive dressing for 48 hours (1st challenge) and 24 hours (2nd challenge)
- Evaluation (hr after challenge): 24h and 48h
OTHER: Approximately twenty-four hours before the topical induction application, the test area was treated with 10% SDS in vaseline, in order to create a local irritation. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 % test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Conclusions:
- Tetrakis(2-ethylhexane-1,3-diolato)titanium demonstrated no sensitizing effect on the skin of female guinea pigs in the Magnusson-Kligman maximization test.
- Executive summary:
Three pairs of intradermal injections of 0.1 ml were given in the shoulder region of animals (20 animals).
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: the 0.5% test substance in corn oil
Injection 3: the 0.5 % test substance in a 1:1 mixture (v/v) FCA/water
Control animals were treated with similar manner
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: corn oil
Injection 3: a 1:1 mixture (v/v) FCA/corn oil
At day 6 before the topical induction application, as the substance was not a skin irritant, the test area, after shaving was handled with 10% SDS in vaseline in order to create a local irritation. At day 7 a filter paper (2 x 4 cm) was fully-loaded with 100% test substance and applied to the test area and held in contact by an occlusive dressing for 48 hours. Control animals were exposed to corn oil in a similar manner. At day 21 second challenge was conducted. A patch loaded with the 100% test substance was applied to one flank of the animals. The patches were held in contact by an occlusive dressing for 24 hours. At 24 hours and 48 hours skin reactions were observed and recorded according to the Magnusson and Kligman grading scale.
At challenge no skin reactions were observed in any animals tested.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The key study by Murmann, P (1990) investigated skin sensitizing potential of tetrakis(2 -ethylhexane-1,3 -diolato)titanium. The substance demonstrated no sensitizing effect on the skin of female guinea pigs in the Magnusson-Kligman maximization test.
The supporting study on structurally similair substance (titanium tetrakis(2 -ethylhexanolate)) was used to evaluate the skin irritation of the substance.
At challenge no sensitization response was observed.
Data of the decomposition products is used for assessment, because the target substance is hydrolytically unstable having the half-life less than 10 minutes. Published information on titanium and TiO2 confirmed that there was no human evidence of skin sensitization, contact dermatitis or appreciable dermal absorption (Clayton & Clayton (eds.), 1981). There is also evidence of a lack of titanium compound toxicity to the skin demonstrated by its use in the therapy of skin disorders and as a biocompatible implant material (West & Wyzan, 1963 cited in WHO, 1982)
As a conclusion on skin sensitization, there is available enough reliable information to support the conclusion that tetrakis(2 -ethylhexane-1,3 -diolato)titanium is not skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Tetrakis(2 -ethylhexane-1,3 -diolato) is not classified for skin sensitization in accordance to the CLP Regulation No. 1272/2008.
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