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EC number: 618-687-6
CAS number: 909709-42-8
No studies performed with the test item are avalaible to assess the skin
and eye irritation potential. However, reliable and adequate OECD
Guideline studies exist for a structural analogue substance. Based on
the results of the in vivo skin irritation study according to OECD
Guideline 404, the structural analogue did not exhibit an irritating
potential. The structural analogue showed a mildly irritating potential
to rabbit's eye in a study according to OECD Guideline 405 under GLP
The test item was mixed with some drops of Aqua pro injectione to ensure
good contact with the skin. Afterwards, the test material was spread
onto patches and applied to the intact skin of previously shaven rabbits
for 4 hours under semiocclusive conditions. The study was performed
initially with one animal and followed by the confirmatory test with two
further animals. The first examination of the treated skin was 1 hour
after patch removal. Thereafter, examinations were performed daily for a
further 7 days.
Under the conditions of the present study, no signs of irritation were
seen. Body weight development of the treated rabbits was inconspicuous.
No skin irritating potential could be detected.
This study was performed according to
GLP and methods applied are fully compliant with OECD TG 404. For the
test item no irritating potential could be detected.
The test item was tested for its eye irritating potential with one
rabbit in a GLP study according to OECD GL 405. Prior to testing, a
hen's egg test on the chorioallantoic membrane was performed and no
irritating potential could be detected. For the test of primary eye
irritation, 100 mg of the test material was applied into the
conjunctival sac. The first examination of the eyes followed 1 hour
after instillation and the other examinations were performed daily for a
further 14 days.
There were no signs of pain immediately after instillation. The cornea
developed diffuse areas of opacity (scores 1) from the first reading up
to day 3 of the experimental part. At the iris signs of irritation were
observed (score 1) from the first reading up to day 4. The conjunctivae
showed redness (scores 1 and 2) and chemosis (score 1) from the first
reading up to experimental day 8. Thereafter no signs of irritation were
observed. The untreated eye was unchanged.
Based on the observed results the test item should be regarded as an
irritant to the eyes.
This GLP study was performed according to OECD GL 405. A eye
irritating potential was noted and the test item should be regarded as
an irritant to the eyes.
Based on the available information, the test item is not classified and
labelled for skin irritation/corrosion according to Regulation (EC) No
1272/2008. However, the test item is classified for eye irritation Cat.
2 and labelled with H319 (Causes serious eye irritation) according to
Regulation (EC) No 1272/2008. The test item is classified as irritating
to eyes (Cat. 2A) according to Globally Harmonized System Of
Classification And Labelling Of Chemicals (GHS), Rev. 7.
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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