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EC number: 235-120-4
CAS number: 12070-08-5
The test item titanium carbide was assessed
for dermal irritation in vitro according to OECD 439. Based on
the results of this test, the test item is not considered a dermal
Eye irritation was assessed in vitro
(BOCP; OECD 437) and confirmed in vivo (OECD 405). No effects
relevant for classification of the test item were observed.
Table 1: Experimental results of the
EPISKIN-SM test after application of Titanium carbide powder.
Mean OD550of 3 replicate tissues (blank-corrected
Relative tissue viabilities (%)
Mean relative tissue viability (%)
SD tissue viability (%)
CV (% viability)
In this in vitro dermal irritation
study with the three-dimensional human skin model EPISKIN-SM conducted
according to OECD TG 439, the irritation potential of Titanium carbide
was examined. The test substance (10 mg) was applied topically on the
tissue for 15 min, and thereafter the exposed tissue culture was
incubated for 42 h. A positive and a negative control were used. The
determination of cytotoxic effects was performed with the MTT assay.
Irritation potential of the test susbstance was determined based on the
cytotoxicity observed (mean tissue viability). All acceptability
criteria were fulfilled. The results revealed a mean relative tissue
viability higher than 50%, and hence, the test substance is not a skin
irritant under the conditions of this test.
Table 2: Mean Values of Eye
Irritation Scores – (24, 48, 72 Hour Reading)
Table 3: Eye Irritation Scores – Animal
(24, 48 and
T = Test item, C = control
Table 4: Eye Irritation Scores – Animal
T = test item, C = control
Table 5: Eye Irritation Scores – Animal
T = test item, C = control
In a primary eye irritation study
according to OECD 405, 0.1 g of titanium carbide was instilled into the
conjunctival sac of one eye each of three female New Zealand White
rabbits (age approximately 13 weeks). Eyes were not washed. Animals were
observed for a total of 72 hours. Irritation was scored by evaluating
conjunctival redness, conjunctival chemosis, iris, and corneal opacity.
Only slight effects visible as conjunctival
redness have been observed which were fully reversible within 72 hours.
Neither mortalities nor significant clinical signs of toxicity were
In this study, titanium carbide is not
an eye irritant.
Table 1: Evaluation of the BCOP Assay
0 – 3
3.1 – 25
25.1 – 55
55 – 80
Very severe irritant
Table 2: Opacity
Change of Opacity Value
Corrected Opacity Value
Table 3: Permeability
Corrected OD490 Value
Table 4: In Vitro Irritation Score
eye irritancy potential of Titanium carbide was investigated in the
bovine corneal opacity and permeability assay according to OECD 437. The
Bovine Corneal Opacity and Permeability (BCOP) test method is an in
vitro test method that can be used to classify substances as “ocular
corrosives and severe irritants”.
corneas each were treated with the test item, imidazole 20 % in physiol.
saline 0.9 % (positive control), and with physiol. saline 0.9 % (negaive
control), respectively, for 4 hours at 32 °C. Optical density was
measured at 490 nm (OD490).
mean in vitro irritation score was 2.19. Thus, titanium carbide is not
classified a severe irritant. The in vitro irritation score obtained
with the positive control fell within the standard deviation of the
Titanium carbide was tested negative
in an in vitro dermal irritation study with the three-dimensional human
skin model EPISKIN-SM (OECD 439). The determination of cytotoxic effects
was performed with the MTT assay. Irritation potential of the test
substance was determined based on the cytotoxicity observed (mean tissue
viability). The results revealed mean relative tissue viability higher
than 50%, and hence, the test substance is not a skin irritant under the
conditions of this test.
The eye irritancy potential was
investigated in the bovine corneal opacity and permeability assay (BCOP)
according to OECD 437. This in vitro test method can be used to classify
substances as “ocular corrosives and severe irritants” only. The mean in
vitro irritation score was 2.19. Thus, titanium carbide is not
classified as severe eye irritant.
The irritation potential was further
evaluated in a primary eye irritation study according to OECD 405.
Titanium carbide was instilled into the conjunctival sac of one eye each
of three female New Zealand White rabbits. Only slight effects have been
observed which were fully reversible within 72 hours. Neither
mortalities nor significant clinical signs of toxicity were observed. In
this study, titanium carbide is not an eye irritant.
Titanium carbide is not considered an irritant to the skin or to the eye in any of the assays of a standard testing battery. Therefore classification according to the criteria set out in regulation (EC) No. 1272/2008 is not warranted.
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