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EC number: 204-667-0
CAS number: 123-96-6
Two in vitro skin irritation and corrosivity studies have been conducted.In vitro and ex vivo eye irritation studies have been conducted.
For the test material the relative mean tissue viabilities obtained
after the 15 minute treatment followed by the 42 hour post-exposure
incubation period were compared to the mean of the negative control
treated tissues (n=3). The relative mean viabilities
were calculated in the following way:
Classification of irritation potential is based upon relative tissue
viability following the 15 minute exposure period followed by the
42 hour post-exposure incubation period according to the following table:
Criteria for in vitro interpretation
Mean tissue viability is =50%
Irritant (I) R38
Mean tissue viability is >50%
Mean OD540Values and Percentage Viabilities for the
Negative Control Material, Positive Control Material and Test
Mean OD540of triplicate tissues
Relative individual tissue viability (%)
Relative mean viability (%)
± SD of % viability
Negative Control Material
Positive Control Material
mean viability of the negative control tissues is set at 100%
The relative mean viability of the test material treated tissues
was 87.8% after a 15 minute exposure.
The MTT solution containing the test material did not turn
blue/purple which indicated that the test material did not
directly reduce MTT.
The substance has been found to be non-irritating to skin
in an in vitro test using
human epidermis model.
Mean OD540Values and Viabilities for the Negative Control,
Positive Control Material and Test Material
Mean OD540of duplicate tissues
Relative mean % viability
*= The mean
viability of the negative control tissues is set at 100%
Following the 3, 60 and 240 minute exposure periods the test
material treated tissues appeared blue which was considered to be
indicative of viable tissue.
The relative mean tissue viability for the positive control treated
tissues was 6.9% relative to the negative control treated tissues
following the 240-minute exposure period. The positive control
acceptance criterion was therefore satisfied.
The test material was considered to be Non-Corrosive to the skin using
the EPISKINTM in vitro Reconstituted Human Epidermis
(RHE) Model after treatment periods of 3, 60 and 240 minutes. This
method was designed to meet the requirements of the following OECD
Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion:
Human Skin Model Test” (adopted 13 April 2004).
In vitro skin irritation and corrosivity studies show the substance to
be non-irritant and non-corrosive to skin.
In vitro and ex vivo eye irritation studies show the substance to have
the potential to cause severe ocular irritancy in vivo.
Effects on eye irritation: highly irritating
Effect level: empty Endpoint conclusion: Adverse effect
available data are considered reliable and give clear results which are
adequate to assign classification under CLP as H318:
Causes serious eye damage. No classification is warranted for skin
irritation or corrosivity.
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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