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EC number: 235-120-4
CAS number: 12070-08-5
results from a bioelution assay demonstrated very low titanium release
from titanium carbide in simulated gastric fluid. Therefore, very low
bioavailability can be expected via the oral route.
a read-across study, titanium dioxide did not show adverse effects after
chronic oral repeated dose exposure in mice and rats.
addition, the results from the bioelution tests with TiC together with
the practical insolubility of the test material in a
transformation/dissolution test lead to the conclusion that no to very
low bioavailability can be expected via
the inhalation and dermal route.
Potential titanium ion release by different
routes of human exposure was compared by using different simulated body
fluids in an in vitro bioelution assay (Cappellini D., 2012, see IUCLID
section 7.1.1). Bioelution of titanium ions from titanium carbide in
simulated gastric fluid was very low after incubation for up to 2 and 24
hours (0.21% and 0.56%, respectively).
These results indicate very low
bioavailability of titanium carbide after oral exposure. In addition,
results from a chronic repeated dose read-across study with titanium
dioxide in mice and rats demonstrated a lack of adverse effects up to a
level of 50,000 ppm in the diet, corresponding to a NOAEL of 6,500 mg/kg
bw/day in mice and 2,500 mg/kg bw/day in rats.
Compared to these NOAELs from the chronic
read-across study, the potential for adverse effects of titanium carbide
after acute short-term exposure can be considered negligible, especially
when taking into account the limited bioavailability demonstrated in the
bioelution assay. Due to the lack of adverse effects in a chronic study
with titanium dioxide and based on the limited bioelution of titanium
carbide in simulated gastric fluid, no adverse effects can be expected
after acute oral exposure to the test substance.
Bioelution has furthermore been assessed for
titanium carbide in artificial perspiration fluid, simulated
interstitial fluid and simulated lysosomal fluid (Cappellini D., 2012,
see IUCLID section 7.1.1). After incubation of the test substance in
perspiration fluid (representing dermal/sweat milieu) for up to 12
hours, the titanium release was below the detection limit.
Under the relatively harsh conditions in
simulated lysosomal fluid (representing phagosomal compartments),
titanium release was very low (0.08% after 24 hours), while titanium
release in simulated interstitial fluid (mimicking conditions in deep
lung) was below detection limit after incubation up to 24 hours.
In conjunction with the practical
insolubility of the substance in a transformation/dissolution test
(Rodriguez et al., 2012, see IUCLID section 4.8), these results indicate
no to very low bioavailability of titanium carbide via inhalation and
dermal exposure. Based on these results, no adverse effects are to be
expected after acute inhalation exposure to the test substance.
The physicochemical properties of the
substance do not suggest relevant dermal absorption potential.
Based on the results of a bioelution assay
in different simulated body fluids and solubility data for the test item
titanium carbide, no to very low bioavailability can be expected via the
dermal and inhalation routes.
For the oral route, the limited bioelution
in simulated gastric fluid suggests very low bioavailability of titanium
carbide. This observation is supported by read-across data from a
chronic oral repeated dose study with the read-across partner titanium
dioxide in mice and rats which demonstrated a lack of adverse effects up
to a level of 50,000 ppm in the diet. Therefore, the NOAEL was
established to be 6,500 mg/kg bw/day in mice and 2,500 mg/kg
bw/day in rats.
As a result, no acute toxic potential of
titanium carbide can be expected and classification according to
Regulation (EC) 1272/2008 for Acute Toxicity or specific target organ
toxicity (STOT) after single exposure, is not warranted.
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