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EC number: 242-745-6
CAS number: 19009-56-4
Skin Corrosion: non-corrosive; OECD 431; Anon, 2017
Skin Irritation: skin irritant (GHS Category 2); OECD 439; Anon, 2017
Eye Irritation: non-irritant; OECD 437; Anon, 2016
Table 1 details the results from all tests performed. Table 2 details
the corrosivity classification based on relative mean viability.
Table 1. Results after treatment with test item and controls
AB-SORBANCE (OD) 570 NMWELL 1
AB-SORBANCE (OD) 570 NMWELL 2
AB-SORBANCE (OD) 570 NMWELL 3
MEAN AB-SORBANCE (OD) OF 3 WELLS MINUS BLANK
MEAN AB-SORBANCE (OD) OF 2 TISSUES
REL. ABSORBANCE[% OF NEGATIVE CONTROL]*
MEAN REL. ABSORBANCE[% OF NEGATIVE CONTROL]*
CORRECTED REL. ABSORBANCE [% OF NEGATIVE CONTROL]***
Negative Control Tissue 1
Negative Control Tissue 2
Positive Control Tissue 1
Positive Control Tissue 2
Test Item Tissue 1
1.723- (0.164-0.199) = 1.758
Test Item Tissue 2
Negative ControlFreeze Killed TissueTissue 1
Negative ControlFreeze Killed TissueTissue 2
Test ItemFreeze Killed TissueTissue 1
Test ItemFreeze Killed TissueTissue 2
1.756- (0.182-0.166) = 1.740
* Relative absorbance (rounded values): ( [100 x (absorbancetest
item/positive control)]/ (absorbance negative control )
) x 100
** ODtest item – (ODtest item freeze-killed
– ODnegative control freeze-killed)
*** Corrected relative viability (%) = [mean OD test item -
(OD test item freeze killed - OD negative control freeze
killed)/mean OD negative control]x 100
Table 2. Classification of corrosivity potential based on relative
VIABILITY MEASURED AFTER EXPOSURE TIME POINTS
PREDICTION TO BE CONSIDERED
< 50% after 3 minutes exposure
≥ 50% after 3 minutes exposure AND
< 15% after 60 minutes exposure
≥ 50% after 3 minutes exposureAND
≥ 15% after 60 minutes exposure
TEST ITEM IDENTIFIED AS CORROSIVE
< 25% after 3 minutes exposure
Optional Sub-category 1A*
≥ 25% after 3 minutes exposure
A combination of optional Sub-categories 1B and 1C
*According to the data generated in view of assessing the usefulness of
the RhE test methods for supporting sub-categorisation, it was shown
that around 29%, 31% and 33% of the Sub-category 1A results of the
EpiDERMTM test method may actually constitute Sub-category 1B
or Sub-category 1C substances/mixtures (i.e. over-classifications)
Skin corrosion potential was measured using the Human Skin Model Test
with EpiDerm™tissues models, in accordance with OECD Guideline for
Testing of Chemicals 431: In vitro Skin Corrosion: Human Skin Model Test
(Updated Guideline adopted July 29, 2016) and the MatTek test protocol
“In vitro EpiDermTM Skin Corrosion Test (EPI-200-SCT)”, 07 November 2014.
The optical pre-experiment (colour interference pre-experiment) to
investigate the test item’s colour change potential in water did not led
to a change in colour. Due to the test item’s MTT-reducing property, an
additional test with freeze-killed tissues to determine a correction
factor for true viability calculation was performed.
Independent duplicate tissues of EpiDermTM were exposed to the test
item, the negative control (deionised water) or the positive control
(8.0 N KOH) for 3 minutes and subsequently 1 hour.
Afterwards, the test and the control items were rinsed off the tissues,
and a 3 hour incubation period (37 ± 1 °C, 5 ± 0.5 % CO2) with MTT
solution followed. MTT solution was then aspirated from the wells and
the wells were rinsed with DPBS. Inserts were transferred into new 24
well plates. The formazan salt was extracted for about 20.5 hours in the
The required acceptability criteria were met.
Exposure to the positive control induced a decrease in the relative
absorbance compared to the negative control, both for the 3 minutes
exposure period (29.4%) and for the 1 hour exposure period (8.7%) thus
confirming the validity of the test system and the specific batch of
After exposure to the test item, the corrected relative absorbance
values were not reduced (109.4% after 3 minutes exposure, 107.3% after 1
hour exposure). The threshold for corrosivity defined to be 50% after
the 3 minutes exposure and 15% after the 1 hour exposure was not
affected. Therefore, the test item is not considered to be corrosive
under experimental conditions, in accordance with EU CLP and UN GHS.
The mean relative absorbance value of the test item, corresponding to
the cell viability, decreased to 8.1%. The test item relative absorbance
(corresponding to cell viability) percentage values were as follows for
the triplicates: 7.1, 8.0, 9.0.
Table 1 demonstrates the results following treatment with the test
Table 1. Tissue absorbance results following treatment
Absorbance 570 nmTissue 1
Absorbance 570 nmTissue 2
Absorbance 570 nmTissue 3
Mean Absorbance of 3 Tissues*
Relative Absorbance [%] Tissue 1, 2 + 3**
Relative Standard Deviation [%]
[% of Negative Control]***
*Mean of two replicate wells after blank correction
**Relative absorbance pre tissue [rounded values]:
) / (mean absorbancenegative control)
***Relative absorbance per treatment
group [rounded values]:
(mean absorbancetest item) / (mean
The substance was tested for skin irritation as per OECD Guideline 439,
28 July 2015 (In vitro skin irritation: reconstructed human epidermis
The test item did not reduce MTT (test for direct MTT reduction), and it
did not change colour when mixed with deionised water (test for colour
interference). Three tissues of the human skin model EpiSkin™ were
treated with the test item, the negative or the positive control for 15
minutes (26.3 µL/cm2). 10 µL of the liquid test item were applied to
each tissue, spread to match the tissue size. The test item relative
absorbance (corresponding to cell viability) percentage values were as
follows for the triplicates: 7.1, 8.0, 9.0.
The mean relative absorbance value of the test item, corresponding to
the cell viability, decreased to 8.1% (threshold for irritancy: ≤ 50%),
consequently the test item was irritant to skin.
Table 1 demonstrates the results of the test groups after 10 minutes
With the negative control (saline) neither an increase of opacity nor
permeability of the corneae could be observed (mean IVIS = 1.44). The
positive control (2-Ethoxyethanol) was tested undiluted and showed clear
opacity and distinctive permeability of the corneae (mean IVIS = 98.08)
corresponding to a classification as serious eye damaging (CLP/EPA/GHS
(Cat 1)). The test item was tested undiluted. Relative to the negative
control, the test item did not cause an increase of the corneal opacity
or permeability. The calculated mean IVIS was 1.02 (threshold for
serious eye damage: IVIS > 55). According to OECD 437, the test item is
Table 1. Results after 10 minutes incubation time
OPACITY VALUE = DIFFERENCE (t130-t0) OF OPACITY
PERMEABILITY AT 490 nm (OD490)
PROPOSED IN VITRO IRRITANCY SCORE
The test item was assessed for eye irritation as per OECD Guideline 437,
26 July 2013.
After a first opacity measurement of the fresh bovine corneae (t0), the
neat test item, the positive, and the negative controls were applied to
corneae fixed in an incubation chamber in horizontal position for 10
minutes at 32 ±1 °C. The posterior chamber contained incubation medium.
After the incubation phase the test item, the positive, and the negative
controls were each rinsed from the corneae. Further, the corneae were
incubated for another 120 minutes at 32 ±1 °C in a vertical position,
while the anterior chamber contain incubation medium as well.
Afterwards, opacity was measured a second time (t130).
After the opacity measurements permeability of the corneae was
determined by measuring spectrophotometrically the transfer of sodium
fluorescein after incubation in a horizontal position for 90 minutes at
32 ± 1 °C.
Relative to the negative control, the test item did not cause an
increase of the corneal opacity or permeability. The calculated mean
IVIS was 1.02 (threshold for serious eye damage: IVIS > 55). According
to OECD 437, the test item is not classified for eye irritation.
The substance meets the criteria for classification as Skin Irritant
Category 2 (Skin Irrit. 2) in accordance with Regulation (EC) No
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