Registration Dossier
Registration Dossier
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EC number: 308-551-1 | CAS number: 98072-94-7 Natural ilmenite ore is concentrated by selective removal of impurities, chiefly iron, to yield a product enriched in titanium dioxide. The process consists of an optional oxidative roast followed by a reductive roasting stage, an acidic leaching stage and washing and drying the product. Alternatively the process consists of selectively chlorinating the iron oxide present in the reduced ore.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Read across concept
Synthetic rutile consists primarily of a titanate phase (solid solution) most of which is titanium in an oxidised form. Upon ingestion, a low rate of dissolution in the GI tract is assumed, based on the experimental verified inertness of the material. Any material being released from Synthetic rutile under physiological conditions will be in the form of ionic titanium, which is similarly the case for titanium dioxide, thus read-across from repeated dose oral toxicity data on titanium dioxide is considered feasible without any restrictions.
Furthermore, transformation/dissolution testing according to “OECD 29 Environmental Health and Safety Publications, Series on testing and assessment, Guidance document on transformation/ dissolution of metals and metal compounds in Aqueous media” has shown that synthetic rutile compared to titanium dioxide has a similar release rate of titanium ions (please refer to the respective entry under the endpoint water solubility).
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 700 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Read across concept
Synthetic rutile consists primarily of a titanate phase (solid solution) most of which is titanium in an oxidised form. Upon ingestion, a low rate of dissolution in the GI tract is assumed, based on the experimental verified inertness of the material. Any material being released from Synthetic rutile under physiological conditions will be in the form of ionic titanium, which is similarly the case for titanium dioxide, thus read-across from repeated dose oral toxicity data on titanium dioxide is considered feasible without any restrictions.
Furthermore, transformation/dissolution testing according to “OECD 29 Environmental Health and Safety Publications, Series on testing and assessment, Guidance document on transformation/ dissolution of metals and metal compounds in Aqueous media” has shown that synthetic rutile compared to titanium dioxide has a similar release rate of titanium ions (please refer to the respective entry under the endpoint water solubility).
The available data on titanium dioxide in rats and mice clearly suggest that ingested titanium dioxide is neither toxic nor carcinogenic to both speciesIn the NCI carcinogenicity study, Fischer 344 rats and B6C3F1 mice were fed diets containing 0, 25000 and 50000 ppm titanium dioxide for 103 weeks (NCI 1979). Based on the histopathological examination, titanium dioxide was considered to be neither toxic nor carcinogenic to rats and mice. Thus, the highest dietary concentration of 50000 ppm titanium dioxide is representing the NOAEL which corresponds to a dose of 3500 mg titanium dioxide/kg bw/d for rats.
Therefore, the oral NOAEL of 3500 mg of titanium dioxide/kg bw/d for chronic toxicity in rats is used as dose descriptor for the calculation of a DNEL for systemic effects for humans exposed orally to different formulations of Titanium dioxide.
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