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EC number: 700-323-3
CAS number: 908020-52-0
The substance was not irritating to skin in rabbits but caused serious damage to eyes of rabbits.
An acute dermal irritation GLP study
according to OECD guideline 404 was conducted in 3 female Japanese White
rabbits in order to evaluate the irritation and corrosion effects of
EEA-NH4 on the skin (Kannami Laboratory, 2008). In this study 0.5 g of
the test substance was applied to a lint sheet (2.5 x 2.5 cm) and
moistened by 0.5 ml of water for injection and then it was applied to
the clipped dorsal skin of rabbits for 3 minutes, 1 hour or 4 hours.
Animals were observed periodically for dermal reactions including the
corrosion reactions according to the Draize method.
There was no tissue damage such as necrosis,
ulcer, hemorrhage and hemorrhagic eschar formation at any site after
exposure to the test substance for 3 minutes, 1 hour or 4 hour.
An exposure of 3 minutes did not result in
dermal reactions at 1 or 24 hours after removal of the test substance.
An exposure of 1 hour did not result in dermal reactions at 1, 24, 48 or
72 hours after removal of the test substance. An exposure of 4 hours
resulted in erythema (score of 1) in 2 animals at 24 hours after removal
of the test substance. However, the erythema was no longer observed 48
hours after removal of the test substance. No edema was observed at any
time period after 4 hours exposure to the substance.
acute eye irritation GLP study according to OECD guideline 405 was
conducted in female Japanese White rabbits in order to evaluate the
irritation and corrosion effects of EEA-NH4 on the eyes(Kannami
Laboratory, 2008). In step 1, 0.1 g of
the test substance which was pulverized in a mortar was applied to the
left eye of 1 rabbit but no corrosive change was observed in the animal
at 1 or 24 hours after application. Therefore, 2 other animals received
the test substance in the same manner in step 2.
all animals, corneal opacity, iridal change, and conjunctival redness,
chemosis and discharge were observed at 1 hour after application. The
irritation reactions were observed similarly up to day 9 after
application. The irritation reactions showed a slight tendency toward
decrease from day 10 after application and iridal change and
conjunctival chemosis were no longer observed by day 12 and by day 16
after application respectively. Conjunctive discharge was no longer
observed by day 21 after application (the final day of observation).
However, corneal opacity was observed in all animals and conjunctival
redness in 1/3 animals and the irritation reactions were not completely
removed. For the other ocular changes, eyelid closure was observed in
all animals immediately after application and in 1/3 animals from 1 hour
to day 4 after application. Additionally, corneal vascularization was
observed in 1/3 animals on day 6 after application and in all animals
from day 7 to day 21 after application. Since corneal opacity and
conjunctival redness were not completely removed the substance was
considered to cause severe damage to the eyes.
test substance related effects in any animal were observed regarding
clinical signs and body weights.
Based on the irreversible effects observed
in the eye irritation test, the substance has to be classified according
to Directive 67/48/EEC as Xi – R41 (Risk of serious damage to eyes). In
accordance to EU Classification, Labeling and Packaging of Substances
and Mixtures (CLP) Regulation (EC) No. 1272/2008, the substance has to
be classified for Eye damage, Cat. 1 - H318 (Causes serious eye damage).
No classification for skin irritation is warranted based on the
available in vivo skin irritation study.
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