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EC number: 948-498-7
CAS number: 143785-33-5
The substance is
not irritating to the
skin and eye.
Change of Opacity Value
Corrected Opacity Value
= mean value
Corrected OD490 Value
= mean value
3: In Vitro Irritation Score
= mean value
4: Historical Mean In Vitro Irritation Score of the Positive Control
IVIS Positive Control - Ethanol 100 %
Mean Value (MV)
Standard Deviation (SD)
Number of Replicates providing Historical Mean: 50
controls are updated after every single experiment or at
least every 3 months
Skin irritation was investigated in an
in vitro skin irritation test using the Reconstructed Human Epidermal
Model - EpiDerm™ Standard Model (EPI-200 -TM) according to OECD
Guideline 439 and following GLP. In
the pre-experiment, a mixture of 30 μL test item per 1 mL MTT medium
showed no reduction of MTT compared to the solvent: the mixture did not
turn blue/purple. Therefore, the non-specific reduction of MTT (NSMTT)
equalled 0%. In the same pre-experiment, a mixture of 30 μL of the test
item per 300 μl aqua dest. and/or per 300 μL isopropanol showed no
colouring detectable by unaided eye-assessment. Therefore, the
non-specific colour (NSC) equalled 0%. In the main experiment, the test
item (undiluted), negative control (DPBS), and positive control (5% SDS
solution) were applied on the tissues in triplicate for 60 minutes
followed by a 42 h post-incubation period. The mean relative tissue
viability (% negative control) was > 50% (77.3%) after 60 min treatment
and 42 h post-incubation. In conclusion, in this study under the given
conditions the test item showed no irritant effects. The relative mean
tissue viability after 60 min of exposure and 42 h post-incubation was >
50%. The test item is therefore classified as “non-irritant” in
accordance with UN GHS “No Category”.
Eye irritation was investigated in a Bovine
Corneal Opacity and Permeability Assay according to OECD 437 and
following GLP. Eyes were collected from a slaughterhouse. The eyes were
carefully examined for defects and any defective eyes were discarded.
750µL of the item (undiluted), negative control (physiological
saline 0.9% NaCl), or positive control (ethanol
100%) were applied in triplicate on the corneas for 10 minutes.
After a 2 -hour post-incubation period the illuminance
measurement (opacity) was performed. After another 90 minutes, the optical
density at 490 nm (OD490) was determined (permeability). Based on the
results, the IVIS-score was determined according to OECD guideline 439.
The IVIS-score was determined to be 1.41. The in vitro irritation
score obtained with the positive control fell within the two standard
deviations of the current historical mean and therefore this assay is
considered to be valid. The negative control responses resulted in
opacity and permeability values that are less than the established upper
limits for background bovine corneas treated with the respective
negative control. In conclusion, according to the evaluation criteria
the test item is classified into UN GHS No Category.
test substance does not have to be classified as irritating to the skin
or eye according to Regulation (EC) No 1272/2008.
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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