Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 609-066-0
CAS number: 35123-06-9
The test substance was investigated in vivo in rabbits for its skin irritation/corrosion and eye irritation/ corrosion potential according to international accepted guidelines. Skin irritation: For the skin, no irritation potential was observed under selected testing conditions.Eye irritation: For the eye, a single application produced slight but transient effects which were fully reversible within the observation period. Therefore the test substance was considered to be not irritant to the eye.
The primary skin irritation potential of the
test substance was investigated according to OECD 404, adopted in 2002.
The test substance was applied by topical semiocclusive application of
0.5 mL to the intact left flank of each of three young adult New Zealand
White rabbits. The duration of treatment was four hours. The scoring of
skin reactions was performed 1, 24, 48 and 72 hours after removal of the
dressing. The mean score was calculated across 3 scoring times (24, 48
and 72 hours after patch removal) for each animal for erythema/ eschar
grades and for oedema grades, separately. The mean erythema/ eschar
score and the mean oedema score were 0.00 for each of the three animals.
The application of the test item to the skin resulted in a very slight
erythema in one animal. This effect was reversible and no longer evident
24 hours after treatment. Two animals remained completely negative. The
test item caused no staining of the treated skin. No corrosive effects
were noted on the treated skin of any animal at any of the measuring
intervals and no clinical signs were observed. Thus, the test substance
did not induce significant or irreversible damage to the skin.
The primary eye irritation potential of the
test substance was investigated according to OECD 405, adopted in 1997.
The test substance was applied by instillation of 0.1 mL into the left
eye of each of three young adult New Zealand White rabbits. Scoring of
irritation effects was performed approximately 1, 24, 48 and 72 hours
after test item instillation. The mean score was calculated across 3
scoring times (24, 48 and 72 hours after instillation) for each animal
for corneal opacity, iris, redness and chemosis of the conjunctivae,
separately. The individual mean scores for corneal opacity and iris were
0.00 for all three animals. The individual mean scores for the
conjunctivae were 1.00, 0.67 and 1.00 for reddening and 0.33, 0.00 and
0.00 for chemosis, respectively. The instillation of the test item into
the eye resulted in mild to moderate, early- onset and transient ocular
changes, such as reddening of the conjunctivae and sclerae, discharge
and chemosis. These effects were reversible and were no longer evident
72 hours after treatment, the end of the observation period for all
animals. No abnormal findings were observed in the cornea or iris of any
animal at any of the examinations. No corrosion was observed at any of
the measuring intervals. No staining of the treated eyes by the test substance
was observed and no clinical signs were observed. Thus, the test substance
did not induce significant or irreversible damage to the rabbit eye.
Based on the available data the test
substance is considered to be “not irritating” to rabbit skin. Therefore
there is no need for classification and labeling acorrding to Directive
67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
Based on the available data the test
substance is considered to be “not irritating” to rabbit eye.
Therefore there is no need for classification and labeling acorrding to
Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again