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EC number: 700-957-0
CAS number: -
Skin irritation (OECD 404): not irritatingEye irritation (OECD 405): not irritating
The skin irritation potential of Y-15866 was investigated in a
GLP-conform study according to OECD guideline 404 (Arcelin, 2011). The
undiluted test substance (0.5 mL) was applied for 4 h to the clipped
skin of 3 young adult New Zealand White rabbits (1 male and 2 females)
under semiocclusive conditions. The scoring of skin reactions (erythema
and edema) was performed 1, 24, 48 and 72 h after removal of the
dressing. The test item did not elicit any skin reactions at the
application site of any animal at any of the observation time points. No
signs of systemic toxicity were seen. The mean erythema and edema scores
after 24, 48 and 72 h were 0 for all 3 animals.
The eye irritation potential of Y-15866 was
investigated in a study according to OECD guideline 405 and in
compliance with GLP (Arcelin, 2010). The undiluted test substance (0.1
mL) was placed into the conjunctival sac of the left eye of 3 young
adult New Zealand White rabbits (1 male and 2 females). Scoring of
irritation effects was performed approximately 1, 24, 48 and 72 h after
test substance instillation. The instillation of Y-15866 into the eye
resulted in mild, early-onset and transient ocular changes, such as
reddening of the conjunctivae and sclerae, as well as chemosis. These
effects were reversible and were no longer evident up to 48 h after
treatment. No abnormal findings were observed in the cornea or for the
iris light reflex of any animal at any of the examinations. No corrosion
and no staining of the treated eyes and no clinical signs were observed.
The individual mean scores for corneal opacity and iris light reflex
after 24, 48 and 72 h were 0 for all three animals. The individual mean
scores after 24, 48 and 72 h for the
conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for
chemosis for all 3 animals.
The available data on skin and eye irritation of Y-15866 do not
meet the criteria for classification according to Regulation (EC)
1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not
sufficient for classification.
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