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EC number: 824-263-3
CAS number: 2196165-14-5
According to the study conducted following the in vitro test OECD 439 the test item has to be considered as non-irritant for the skin.
According to the study conducted following the in vitro test OECD 437 no prediction can be made for the eye irritation potential of the substance. However, the structural analogue substance CAS number 68877-33-8 Direct Black 155- Na salt is classified as Eye Damange Category 1 as a result of the finidngs in a OECD 437 study.
A read-across from this structural analogue is used to assess the eye corrosion/irritation potential of Direct Black 155 - Na, K, Li salt and therefore, it is considered to be Eye Dam. 1.
Results after treatment with the substance and the controls
* relative viability [rounded values]:
** Mean relative viability [rounded values]:
*** corrected value
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did lead to a change in colour. Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did show blue/purple colour. The mean relative viability of the test item, corresponding to the cell viability, decreased to 106.68% (threshold for irritancy: ≤ 50%), consequently the test item was non-irritant to skin.
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test.
The test item did reduce MTT (test for direct MTT reduction). Also, its intrinsic colour was intensive. Conseque ntly, additional tests with freeze-killed, viable tissues and non-specific killed controls were necessary.
Each three tissues of the human skin model EpiDerm™were treated with the test tem, the negative control (DPBS) or the positive control (5% SDS) for 60 minutes.
After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD³0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system.
After treatment with the test item the mean relative viability value was 102.06 %compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%.Therefore, the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is non-irritant to skin.
of the first experiment after 240 Minutes Treatment Time
Opacity value = Difference (t240-t0) of Opacity
Permeability at 490 nm (OD490)
Proposedin vitroIrritancy Score
No prediction can be made
# Negative values are set to zero
of the second experiment after 240 Minutes Treatment Time
# Negative values are set to zero
This in vitro study was performed to assess the corneal irritation and
damage potential of the substance by means of the BCOP assay using fresh
The experiment was performed twice on sponsor’s request. The result of
the first experiment could be confirmed.
After a first opacity measurement of the fresh bovine corneae (t0), the
20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of
the test item as well as the positive and the negative controls were
each applied to different corneae fixed in an incubation chamber in
horizontal position and incubated for 240 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 and opacity was measured again (t240).
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.
With the negative control (physiological saline) neither an increase of
opacity nor permeability of the corneae could be observed.
The positive control (10% (w/v) benzalkonium chloride in saline) showed
clear opacity and distinctive permeability of the corneae corresponding
to a classification as serious eye damage (EU CLP/UN GHS Category 1).
Relative to the negative control, the test item caused an increase of
the corneal opacity. In the first experiment the calculated mean in
vitro irritancy score was 36.33 and in the second experiment 25.13.
According to OECD 437 (see table in chapter 3.8.3) the test item is not
classified as serious eye damaging (EU CLP/UN GHS Category 1) but the
test item’s hazard for eye damaging cannot be predicted.
No classification for skin irritation/corrosion is warranted under Regulation 1272/2008
Based on the available information and applying the criteria of Annex I of EU Regulation 1272/2008, the substance is classified as Serious eye damaging, Eye Dam 1.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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