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EC number: 204-649-2
CAS number: 123-76-2
Non- skin irritant
The potential of the test item to be
irritant to the skin was investigated through an in vitro skin
irritation study, using a commercial reconstructed human epidermis (RhE)
model named EPISKIN™. The study was performed according to the OECD
Guideline 439. The test item, as well as controls, were tested for their
ability to impair cell viability after an exposure period of 15 minutes
followed by a 42 ± 1 hour recovery period. The blank, negative and
positive controls gave acceptable results and the study was accepted as
valid. After appropriate subtraction, the mean cell viability of the
test item treated tissues was 62 %. Based on the tissue viability
obtained, the substance is not considered to be a skin irritant.
The potential of the test material to
induce eye irritation was investigated in a human cornea model in an
in-vitro study, performed according to the OECD Guideline 492. The test
item was applied to a three-dimensional human cornea tissue model in
duplicate for an exposure time of 30 minutes. 50 μl of the liquid test
item was applied to each tissue. After treatment, the respective
substance was rinsed from the tissue; then, cell viability of the
tissues was evaluated by addition of MTT, which can be reduced to
formazan. The formazan production was evaluated by measuring the optical
density (OD) of the resulting solution. Demineralised water and methyl
acetate were tested concurrently as negative and positive control
respectively. The mean tissue viability was found to be 2.5 %. This
value is well below the threshold for eye irritation potential (≤ 60 %).
Under the conditions of the test system, the test substance is
considered as eye irritant or inducing serious eye damage in the
EpiOcularTMEye Irritation Test.
In order to distinguish between eye
irritant and induing serious eye damage, the substance was further
evaluated in-vitro according to the OECD 437.
The corneal damage potential of the
substance was assessed by quantitative measurements of changes in
opacity and permeability in a bovine cornea. The test item was brought
onto the cornea of a bovine eye which had been incubated with cMEM
without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been
measured. The test item was incubated on the cornea for 10 minutes at 32
± 1 °C. After removal of the test item and 2 hours post-incubation,
opacity and permeability values were measured. The calculated IVIS (in
vitro irritancy score) was 84.29 which is within the range for
classification (according to the classification criteria of OECD 437) of
the substance as causing serious eye damage.
According to the Guidance on the
application of CLP criteria (v.5.0), the OECD 439 can reliably
distinguish non-classified from classified substances. All four methods
of the OECD 439 are valid for the classification of substances for skin
irritation according to CLP criteria. Considering the mean tissue
viability obtained after the exposure to the substance the substance is
not classified for skin irritation, since the tissue viability is above
the threshold for classification (60 %).
According to the Guidance on the
application of CLP criteria (v.5.0), the OECD 492 can be used for
identifying substances not causing serious eye damage/eye irritation.
Based on the tissue viability obtained during the OECD 492 study, the
substance can be considered as an eye irritant or inducing eye damage.
To distinguish between these two classifications, the substance was
further tested in the OECD 437. The IVIS score obtained was above 55,
which is the threshold for classifying a substance as one that induces
serious eye damage. A substance can be considered as causing serious eye
damage (Category 1) based on positive results in the BCOP test (OECD
437). The substance is therefore classified in Category 1- Eye damage
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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