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EC number: 807-889-1
CAS number: 1255203-42-9
D-C16 is non-irritant in the in vitro Episkin skin irritation test.D-C16 did not induce ocular irritation in a BCOP test inducing an IVIS ≤ 3; therefore, no classification is required for eye irritation or serious eye damage.
The study describes the ability of D-C16 to induce skin irritation on a
human three dimensional epidermal model (EPISKIN Small Model (EPISKIN-SM
TM )). The possible skin irritation potential of D-C16 was tested
through topical application for 15 minutes. The study procedures
described in this report were based on the most recent OECD and EC
Skin tissue was moistened with 5 µL of Milli-Q water and an excessive
amount of D-C16 was applied directly on top of the skin tissue for 15 ±
0.5 minutes. After a 42 hour post-incubation period, determination of
the cytotoxic (irritancy) effect was performed. Cytotoxicity is
expressed as the reduction of mitochondrial dehydrogenase activity
measured by formazan production from MTT at the end of the treatment.
Skin irritation is expressed as the remaining cell viability after
exposure to the test substance. The relative mean tissue viability
obtained after 15 ± 0.5 minutes treatment with D-C16 compared to the
negative control tissues was 106%. Since the mean relative tissue
viability for D-C16 was above 50% after 15 ± 0.5 minutes treatment D-C16
is considered to be non-irritant.
The positive control had a mean cell viability of 44% after 15 ± 0.5
minutes exposure. The absolute mean OD 570 (optical density
at 570 nm) of the negative control tissues was within the laboratory
historical control data range. The standard deviation value of the
percentage viability of three tissues treated identically with positive
control was 27%, which was due to one outlier. However, since the other
2 viabilities were clearly positive and within the historical data range
and furthermore the test substance showed a clearly negative result this
did not affect study integrity. The standard deviation value of the
percentage viability of three tissues treated identically with negative
control or test substance was less than 8%.
Finally, it is concluded that this test is valid and that D-C16 is
non-irritant in the in vitro skin irritation test under the experimental
conditions described in this report.
Summary of opacity, permeability and in vitro scores
Mean In vitro Irritation Score*
* Calculated using the negative control mean opacity and mean
permeability values. In vitro irritancy score (IVIS) = mean opacity
value + (15 x mean OD490 value).
Evaluation of the eye hazard potential of D-C16 was performed
using the Bovine Corneal Opacity and Permeability test (BCOP test, OECD
429). The report describes the potency of chemicals to induce serious
eye damage using isolated bovine corneas. The eye damage of D-C16 was
tested through topical application for approximately 240 minutes.
Batch 14-002 of D-C16 was a white crystal with a purity of 99.3%.
Since no workable suspension in physiological saline could be obtained,
the test substance was used as delivered and added pure on top of the
corneas (321.7 to 358.4 mg).
The negative control responses for opacity and permeability were
less than the upper limits of the laboratory historical range indicating
that the negative control did not induce irritancy on the corneas. The
mean in vitro irritancy score of the positive control (20% (w/v)
Imidazole) was 135 and within the historical positive control data
range. It was therefore concluded that the test conditions were adequate
and that the test system functioned properly.
D-C16 did not induce ocular irritation through both endpoints,
resulting in a mean in vitro irritancy score of -0.5 after 240 minutes
of treatment. Since D-C16 induced an IVIS ≤ 3, no classification is
required for eye irritation or serious eye damage.
D-C16 was tested for skin and eye irritation/damage in two in vitro
In an Episkin model test no signs of irritation by the test substance
were observed and thus the substance is not considered a skin irritatnt.
Furthermore, in a BCOP test for eye irritation/damage, no irritation was
noted and thus the substance is also not considered being an eye
As D-C16 neither induced skin nor eye irritation in two in vitro tests
(Episkin and BCOP) the substance is not subject to classification and
labelling for skin or eye irritation according to CLP (Regulation EC No
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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