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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The weight of evidence approach is used to determine the sensitization hazard of titanium tetrabutanolate evaluating relevant data from the substance itself but also from the decomposition products and from the analogue category member. Read-across data from the decomposition products (n-butanol and titanium dioxide) is used for assessment, because the target substance is hydrolytically unstable having the half-life less than 5 minutes (Brekelmans, M. J. C., 2013).
The potential sensitization properties of titanium tetrabutanolate were tested in non-guideline primary sensitization test on guinea pigs. The test substance was administrated as 1 % solution (vol/vol) in a series of four sacral intradermal injections (10 animals). At the time of challenge 0.05 ml 5 % and 50 % test substance (vol/vol) was applied and lightly rubbed to the shaved intact shoulder skin. A control group of 10 previously unexposed guinea pigs received similar applications at the same time to provide a direct comparison of the challenge reactions. At challenge no sensitization response was observed in any dose level tested. Based on the study results test substance is considered as not a skin sensitizer.
Further evidence on the skin sensitization comes from titanium tetraisopropanolate, the analogue category member of the target substance. All titanates in this category behave similar way when in contact with water. Isopropyl alcohol is released from titanium tetraisopropanolate and n-butanol from titanium tetrabutanolate when the substances are in contact with water. Released alcohols have no harmonized classification entries as sensitizers. The category justification and the read-across justifications are presented in the Annexes of the CSR.
The local lymph node assay (LLNA) by Dreher (2010) was conducted for analogue category member in compliance with GLP conditions and according to EU method B.42. The test substance did not demonstrate any evidence of skin sensitivity.
n-Butanol, the degradation product of the target substance, is not likely to be a skin sensitizer since the substance have no classification as skin sensitizer according to EU regulation No. 1272/2008 (CLP).
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 information from the substance itself, from the analogue category member and from the degradation products to support the conclusion that titanium tetrabutanolate is not skin sensitizer.
Migrated from Short description of key information:
Primary sensitization study in guinea pigs: negative (conducted for the target substance)
LLNA study: negative (conducted for the analogue category member)
Justification for selection of skin sensitisation endpoint:
Conclusion based on the following assays: Primary sensitization study in guinea pigs conducted for the target substance and LLNA study conducted for the analogue category member.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Titanium tetrabutanolate is not classified for skin sensitization in accordance to the CLP Regulation No. 1272/2008 and EU Directive 67/548/EEC.
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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