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SKIN IRRITATIONThe skin irritation properties of 400160 were investigated in an in vitro skin irritation test (Reconstructed human epidermis model test). This test is a stand-alone replacement test for in vivo skin irritation testing. Hence, no in vivo study was conducted. The result of the in vitro study indicated no skin irritation potential. EYE IRRITATION The eye irritation properties of 400160 were assessed in an in vitro study (BCOP) and in an in vivo study (Draize test). No irritating effects could be observed in the in vitro study. A slight to moderate redness and chemosis was noted in the in vivo study which was totally reversible.RESPIRATORY IRRITATIONThe respiratory irritation of 400160 was not studied.
Skin irritation/corrosion in vitro
An in-vitro study human skin model
test (EU method B.46) was performed in order to evaluate the potential
of 400160 to evoke skin irritation in a human skin model. 400160 was
spread on the surface of three sections of an EpiDermTM tissue and
incubated for 60 min. The negative control consisting of Dulbecco’s
phosphate buffered saline was applied to another three tissue sections.
As positive control a SDS solution (50 g/L) was used for three other
tissue sections. An enzyme assay with MTT-reagent to determine cell
viability was performed. The mean percentage values of formazan
production were calculated in comparison to the negative control. The
relative absorbance values were increased to 100.9% after the treatment
with 400160. This value is well above the threshold for irritation
(50%). The positive control showed a reduction of formazan production of
6.5%. In conclusion, it can be stated that the test item 400160 is
considered as not skin irritant under the experimental conditions used
in this study.
Skin irritation/corrosion in vivo
According to Annex VIII section
8.1.1., an in vivo skin irritation test does not have to be conducted
when an acute toxicity study by the dermal route does not indicate skin
irritation up to the limit dose level (2000 mg/kg bw). 400160 does not
show any signs of skin irritation/corrosion in a relevant dermal
toxicity test (see section 7.2.3. of this IUCLID file). The test was
performed as limit test (2000 mg/kg bw).
Furthermore, the skin irritation
potential of 400160 was determined in vitro using the “reconstructed
human epidermis test method” according to OECD guideline 439. According
to OECD guideline 439 par. 1 this test method can be used to determine
the skin irritancy of chemicals as a stand-alone replacement test for in
vivo skin irritation testing. Therefore, the in vivo skin irritation
test can be waived due to animal welfare concerns.
Eye irritation in vitro
The BCOP test (OECD GL 437) was
performed to assess the corneal irritation and damage potential of
400160 by quantitative measurements of changes in opacity and
permeability in a bovine cornea. The test item solution in olive oil
(10% w/v) was brought onto the cornea of a bovine eye which previously
had been incubated with cMEM ( = complete Minimum Essential Medium)
without Phenol red at 32±1°C for 1 h and whose opacity had been
determined. The test item was incubated on the cornea for 10 min at
32±1°C. After removal of the test item solution, opacity and
permeability values were measured. Physiological sodium chloride
solution was used as negative control, olive oil was used as solvent
control. The negative control and the solvent control showed no
irritating effect on the corneas. 10% sodium hydroxide solution was used
as positive control. The positive control induced severe irritation on
the cornea, mean IVIS was 166.67. The negative control showed no
irritation, mean IVIS was 0.81. For the test item solution, a mean IVIS
of 0.6790 was calculated, corresponding to a classification as not eye
Eye irritation in vivo
The eye irritation properties of
400160 were tested according to OECD guideline 405. 0.1 mL of the test
item was instilled into the conjunctival sac of one eye of young adult
New Zealand White rabbits (3/male). Animals then were observed for 3 d,
and in addition after 7 d to confirm reversibility. Irritation was
scored according to the EU guideline. The conjunctivae reactions
observed during the study were slight to moderate and totally reversible
in the three animals: a slight to moderate redness noted 1 h after the
test item instillation was totally reversible between d 3 and 7; a
slight to moderate chemosis noted 1 h after the test item instillation
was totally reversible between d 2 and 3. Therefore, 400160 is not an
eye irritant and do not have to be classified.
Based on the results of the skin and
eye irritation studies given above, 400160 is not classified as skin or
eye irritant according to the current EU-CLP regulation.
A classification of 400160 for
respiratory irritation is not possible, as no respiratory irritation
study was conducted.
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