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EC number: 928-779-0
CAS number: -
No skin irritation was caused by 4 hours of
There was no evidence of a corrosive effect
on the skin
Yellowish staining of the treated skin by
the test substance was observed on day 1.
No symptoms of systemic toxicity were
observed in the animals during the test period and no mortality
The mean in vitro irritation score was
calculated to be 12.64. According to IVIS criteria, no predication could
be made regarding the UN GHS classification of the test substance.
to Annex VII guidelines (ECHA 2015),in vitrotesting for eye
irritation is recommended as part of an integrated testing strategy. The
BCOP assay (OECD 437) is suitable for this class of materials and is
sufficiently robust to determine the eye irritation potential. The
assay generates an In Vitro Irritancy Score (IVIS). This
assay is capable of identifying materials with CLP Category 1 responses
(Serious eye damage). This
assay can also identify materials with little or no eye irritation
potential for which no classification is necessary. Responses
from the BCOP resulting in either of these results are considered
conclusive and no further testing is required. If
the results from the BCOP fall outside the range of either of these two
classification ranges, then additional testing would be possible to
better define the eye irritation classification (i.e. Category 2A or 2B).
For the test substance, a BCOP assay
was conducted and a mean IVIS score of 12.64 was determined.
The in vitro irritation score was not high
enough to be classified as a Category 1 eye irritant, but not low enough
to be unclassified.
Therefore, no prediction can be made
regarding the classification of the test substance according to the
evaluation criteria of the BCOP assay as the IVIS result fall outside of
the classification ranges. However, it can be assumed according to
results of histopathology that the test item requires classification for
an eye irritant.
Therefore, based on the available data and
assuming a worst case scenario decision, the substance will be
classified for CLP Category 1 Eye Irritant (H318).
Not classified based on the available data.
Based on the available data and assuming a
worst case scenario decision, the substance will be classified for CLP
Category 1 Eye Irritant (H318).
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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