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EC number: 432-170-0
CAS number: -
* Mean of three replicate wells after blank correction
**relative absorbance: = 100 x (absorbance of test item)/ (absorbance of
The optical evaluation of the MTT-reducing capacity of the test item
after one hour incubation with MTT-reagent did not show evidence of a
blue colour and thereby was not considered to be a MTT reducer.
The test item D-100 is considered to be non-corrosive to skin:
- since the viability after 3 minutes exposure is greater than 50 % and
- the viability after 1 hour exposure is greater than 15%.
This in vitro study was performed to assess the corrosive potential of
D-100 by means of the Human Skin Model Test. Independent duplicate
tissues of the human skin model EST-1000™ were exposed to the test item,
the negative control or the positive control for 3 minutes and 1 hour,
respectively. About 25 mg of the solid test material were applied to the
tissues and wetted with 50 μL deionised water. A volume of 50 μL of
either the negative control (deionised water) or the positive control
(8.0 N KOH) was applied to each tissue. After exposure to the negative
control the absorbance values exceeded the required acceptability
criterion of mean OD570 ≥ 0.8 for both treatment intervals thereby
confirming the acceptable quality of the tissues. Exposure to the
positive control induced a decrease in the relative absorbance as
compared to the negative control, both for the 3 minutes exposure period
and for the 1 hour exposure period thus confirming the validity of the
test system. After exposure to the test item D-100 the relative
absorbance values decreased to 72.7% after 3 minutes. After the 1 hour
exposure relative absorbance values were reduced to
80.7%. Nevertheless, both values are well above the threshold of 50% for
the 3 minutes exposure and above 15% for the 1 hour exposure. Therefore,
the test item was considered to be not corrosive. In conclusion, it can
be stated that in this study and under the reported experimental
conditions, the test item D-100 was non corrosive to skin according to
UN GHS / EU CLP Cat.1 / DSD (67/548/EEC).
Table of results.
Results after 240 minutes incubation time.
**negative values are only calculated values that do not reflect
This in vitro study was performed to assess the corneal irritation and
damage potential of D- 100 by means of the BCOP assay using fresh bovine
corneae. 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 D-100, the positive, and the negative controls
were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. The
posterior chamber contained MEM medium supplemented with sodium
bicarbonate and Lglutamine and 1% fetal calf serum (FCS) (complete
medium = cMEM). 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 (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 effects corresponding to a classification
as corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test item D-100 did not cause any
increase of the corneal opacity or permeability. The calculated mean in
vitro irritation score was 0.00. According to OECD 437 the test item is
classified as not corrosive / not severe irritant to the eye. In
conclusion, according to the current study and under the experimental
conditions reported, the test item D-100 is not corrosive / not severe
irritant to the eye (CLP/EPA/GHS (Cat 1)).
Key test report reveiles that the test substance is not irritant and not
corrosive to the skin and not irritant / corrosive to the eye.
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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