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EC number: 272-249-5 | CAS number: 68784-47-4
- 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
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across valid as the substnace tested is also titanate complex with glycol and alkylamine, degrading in water to similar degradation products.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Method of administration:
Oral gavage - Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- 7 d / wk
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Clinical signs:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Details on results:
- Clinical observations:
No deaths and no signs of toxicity were observed.
Only limited details provided in NONS summary
Laboratory findings:
No treatment-related changes in haematological parameters
were observed.
Slight (1-3%) increases in plasma sodium and chloride were
observed in males at all doses as were slight (20-30%)
decreases in triglycerides. These changes were not observed
in males which received 1000 mg/kg/day and were allowed to
recover for 2 weeks.
Effects in organs:
No treatment-related gross or microscopic findings were
observed. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Key result
- Critical effects observed:
- no
- Conclusions:
- Dosing Sprague-Dawley rats with dose levels of up to 1000 mg/day produced only equivocal haematology and clinical
chemistry effects in either sex not considered to be related to the test material.
Therefore is was concluded that the test material is not classified under the test conditions.
No adverse effects noted up to 1000 mg/kg/day - Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Method of administration:
Oral gavage - Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- 7 d / wk
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Clinical signs:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Details on results:
- Clinical observations:
No deaths and no signs of toxicity were observed.
Only limited details provided in NONS summary
Laboratory findings:
No treatment-related changes in haematological parameters
were observed.
Slight (1-3%) increases in plasma sodium and chloride were
observed in males at all doses as were slight (20-30%)
decreases in triglycerides. These changes were not observed
in males which received 1000 mg/kg/day and were allowed to
recover for 2 weeks.
Effects in organs:
No treatment-related gross or microscopic findings were
observed. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Key result
- Critical effects observed:
- no
- Conclusions:
- Dosing Sprague-Dawley rats with dose levels of up to 1000 mg/day produced only equivocal haematology and clinical
chemistry effects in either sex not considered to be related to the test material.
Therefore is was concluded that the test material is not classified under the test conditions.
No adverse effects noted up to 1000 mg/kg/day
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Extensive testing and reviews have been conducted on titanium dioxide, triethanolamine and propylene glycol, demonstrating limited adverse effects over repeat application. Propan-2-ol vapour may cause some adverse effects at very high levels, but it is not considered likely that even under condition of rapid degradation in water, propan-2-ol vapour will form due to the high water solubility of the alcohol.
Propan-2-ol NOAEL 1000 mg/kg/day, but with slight liver weight increase. This is reported as part of a reproduction toxicity assay. Review by the EU Scientific Committee on Health and Environmental Risks conclude low toxic risk (25th plenary on 9 September 2008)
http://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_105.pdf
Triethanolamine, NOAEL 1000 mg/kg/day over 90 days (Disseminated dossier, Source: European Chemicals Agency,http://echa.europa.eu/)
Titanium complexes of ammonium lactate, triisopropanolamine and polyethylene glycol is included as a supporting study, with only a slight change in blood parameters that were not considered to be adverse.
90 day inhalation,Propan-2-ol Regul Toxicol Pharmacol.1996 Jun; 23(3):183-92. Isopropanol: summary of TSCA test rule studies and relevance to hazard identification. Kapp RW JR et al) the study result was to be NOAEL 5000 ppm
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.