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EC number: 939-457-4
CAS number: 1469983-50-3
* For the 24, 48 and 72 h timepoints
Details of eye irritation scores (according to Draize)
hydroxysultaine, as a 41.5% solution (Betadet SHR), has been tested for
acute eye irritation on 3 male New Zealand White rabbits, in accordance
with OECD test guideline 405, and in compliance with Good Laboratory
The test article was applied
as such in a single conjunctival dose of 0.1 mL in the right eye of each
rabbit, the untreated eye being used as a control. Ocular examinations,
grading cornea, iris and conjunctiva (redness and chemosis) reactions,
were performed at 1, 24, 48, 72 hours, and on day 7, 14 and 21 after
instillation of the test article.
Within the first hour following instillation, the test article induced
conjunctival abnormalities including hyperhaemia ranging from grade 2
(diffuse, crimson color, individual vessels not easily discernible) to
grade 3 (diffuse, deep red color), edema ranging from grade 2 to 3,
redness of the bulbar conjunctivae, lacrimation and congestion and
injection of the iris (grade 1).
At the observations carried out 24, 48 and 72 hours after instillation,
all rabbits showed hyperhaemia ranging from grade 2 to grade 3, chemosis
from grade 1 to grade 3, redness of the bulbar conjunctivae, lacrimation
and congestion and injection of the iris (grade 1). Corneal opacity
(grade 1) was also observed in all animals.
Some of the corneal and conjunctival abnormalities persisted up to day
14 after instillation inclusive. Conjunctival chemosis was still
observed in one of the rabbits 21 days after instillation of the test
Based on these results,
Cocamidopropyl hydroxysultaine, as a 41.5% solution, was considered a
severe eye irritant.
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