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EC number: 943-540-0
CAS number: -
A skin irritation study in two New Zealand White rabbits using semi-occlusive dressings. Skin irritiation was evaluated using the Draize method.
A skin irritation study in six New Zealand White rabbits using both abraded and non-abraded skin and fully occlusive dressings. Skin irritation was evaluated using the Draize method.
An eye irritation study in six New Zealand White rabbits. Eye irritation was evaluated using the Draize ocular irritation scoring method.
The study was performed to assess the
irritancy potential of the test item to the skin of the New Zealand
A single 4-Hour, semi-occluded application
of the test item to the intact skin of two rabbits produced no erythema
and no edema. Both treated skin sites appeared normal at the 7-Day
The test item produced a primary
irritation index of 0.0 and was not classified as irritant to rabbit
skin according to the Draize classiﬁcation scheme and not classified
according to EU classification. No corrosive effects were noted.
A group of six New Zealand white rabbits
were clipped over a wide area. One side of the animals' backs was
abraded with a lancet needle. A 0.5 ml potion of the test material was
applied to an abraded and an intact portion of the skin on the same
rabbit. Gauze patches were then placed over the treated areas and an
impervious material was wrapped snugly around the trunks of the animals
to hold the patches in place. The wrapping was removed at the end of 24
hours and the treated areas were examined. Readings were also made after
72 hours. The Draize method of scoring was employed.
The test substance caused an overall
primary irritation score of 1.38. The test substance is not classified
in accordance with Regulation (EC) No. 1272/2008
In a study conducted according to Section
1500.02 Federal Hazardous Substances Act Regulations CFR 16 P.125 the
test chemical was placed into the right eye of each of 6 New Zealand
White rabbits. The untreated eye acted as a control. The eyes were not
washed after instillation. Treated eyes were examined at 1, 2, 3, 4 and
7 days after instillation.
No irritation score greater than zero was
recorded for any tissue of any of the six animals at any of the
The test substance is not an irritant to
the eye of rabbits. The test material is not classified in accordance
with Regulation (EC) No. 1272/2008
Justification for selection of skin irritation / corrosion endpoint:
Justification for selection of eye irritation endpoint:
In the Key dermal irritation study, treatment
with the test item resulted in an overall primary skin irritation score of
0.0, which is not sufficient for the substance to be classified.
In the supporting dermal irritation study, which
used fully occlusive dressings, treatment with the test item caused an
overall primary skin irritation score of 1.38, which is not sufficient
for the substance to be classified.
Treatment with the test item caused an
overall primary eye irritation score of 0.0, which is not sufficient for
the substance to be classified.
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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