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Diss Factsheets
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EC number: 432-240-0 | CAS number: 12056-51-8
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- AF for dose response relationship:
- 1
- Justification:
- Default AF; Clear NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF; local effects 90 day study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF; inhalation and local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF; workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50.67 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- AF for dose response relationship:
- 3
- Justification:
- Extrapolate LOAEC to NOAEC (see R.8.4.3.4)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF; inhalation and local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF; workers
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Potassium titanium oxide is an inert, inorganic particulate material with very low water solubility. Depending upon the method of manufacture it is an inhalable and potentially respirable particulate, with a potential fibre content.
Inhalation exposure is the only relevant route of exposure. Inhalation and retention of particles in the lung and the inability to clear the lung are key concerns.
In standard studies conducted in 2000 there was no evidence of irritation to skin and eye and no sensitisation potential. Systemic exposure is considered to be minimal by any relevant route, including inhalation, because of the physic-chemical properties of the substance. Further, there was no evidence of systemic effects in two 90 day repeat dose studies via the inhalation route. The changes noted were considered to be local to the lung.
The 90 day studies were carried out using products with a small particle size, in which a significant proportion would be expected to reach and be deposited in the alveolar region of the lung. The TOFIX product tested, TOFIX-S, also had a significant fibre content. In the absence of a carcinogenicity study the NOAEL for the 90 day study has been used to determine a DNEL, recognising that the potential effects of fibres are likely to follow from lung overload (see below). The TOFIX products currently on the market in Europe have a larger median particle size than the versions used in these two tests, being inhalable rather than respirable, although it is recognised that they are likely to have a respirable fraction. They also have a very low (TOFIX-SNR) fibre content.
It is recognised that very high exposures to such particles (fine dust) can cause overload which the lung struggles to deal with. The rat is particularly sensitive to lung damage caused by poorly soluble particulates (Levy, 1994). In the longer term if they cannot be cleared by the physiological clearance mechanisms there is the potential for chronic diseases caused by a persistent inflammatory response. With this in mind, inhalation DNELs have been calculated for both long-term and acute exposures, the latter reflecting the evidence of effects seen at high doses. The DNELs calculated are specific to potassium titanium oxide, but noting that there are control limits for dusts, the exposures need also to be compared with the existing control limit for such dusts. Within the UK the COSHH definition of a substance hazardous to health includes dust of any kind for which there is not a specific limit for the substance. The Occupational Exposure Limits (OELs) for inhalable and respirable dusts in air are 10 mg/m3 8-hour TWA and 4 mg/m3 8-hour TWA respectively. The median particle sizes of the TOFIX products currently on the market are in the inhalable range, so the 10 mg/m3 limit is considered appropriate for comparison. Exposure to dipotassium titanate in the workplace can be controlled by appropriate RMMs.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.79 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 50
- AF for dose response relationship:
- 1
- Justification:
- Default AF; Clear NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for local effects
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF; inhalation and local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF; general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25.33 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- LOAEC
- AF for dose response relationship:
- 3
- Justification:
- Extrapolate LOAEC to NOAEC (see R.8.4.3.4)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default AF; inhalation and local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF; general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Potassium titanium oxide is an inert, inorganic particulate material with very low water solubility. Depending upon the method of manufacture it is an inhalable and potentially respirable particulate, with a potential fibre content.
Inhalation exposure is the only relevant route of exposure. Inhalation and retention of particles in the lung and the inability to clear the lung are key concerns.
In standard studies conducted in 2000 there was no evidence of irritation to skin and eye and no sensitisation potential. Systemic exposure is considered to be minimal by any relevant route, including inhalation, because of the physic-chemical properties of the substance. Further, there was no evidence of systemic effects in two 90 day repeat dose studies via the inhalation route. The changes noted were considered to be local to the lung.
The 90 day studies were carried out using products with a small particle size, in which a significant proportion would be expected to reach and be deposited in the alveolar region of the lung. The TOFIX product tested, TOFIX-S, also had a significant fibre content. In the absence of a carcinogenicity study the NOAEL for the 90 day study has been used to determine a DNEL, recognising that the potential effects of fibres are likely to follow from lung overload (see below). The TOFIX products currently on the market in Europe have a larger median particle size than the versions used in these two tests, being inhalable rather than respirable, although it is recognised that they may have a respirable fraction. They also have a very low (TOFIX-SNR) fibre content.
It is recognised that very high exposures to such particles (fine dust) can cause overload which the lung struggles to deal with. The rat is particularly sensitive to lung damage caused by poorly soluble particulates (Levy, 1994). In the longer term if they cannot be cleared by the physiological clearance mechanisms there is the potential for chronic diseases caused by a persistent inflammatory response. With this in mind, inhalation DNELs have been calculated for both long-term and acute exposures, the latter reflecting the evidence of effects seen at high doses.
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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