Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.