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EC number: 413-110-2
CAS number: 135861-56-2
No experimental data are available for respiratory irritation
In the key acute skin irritancy study (Pharmakon Europe, 1993), 0.46 mg
of the test material was applied under semi-occlusive dressings to the
skin of six New Zealand White rabbits for 4 hours, followed by a 72
-hour observation period. Reactions at the application
site were confined to very slight or occasional well-defined erythema
amongst the animals. There was no oedema observed. The low irritancy of
the material was supported in a more recent study (Safepharm
Laboratories Ltd,. 1998), in which similar administration of 0.5 g of
the test substance to three New Zealand White rabbits elicited no
irritant response at any of the application sites.
In the key in vivo eye irritation study (Pharmakon Europe, 1993),
instillation of 20 mg of the test substance to a single eye of six
rabbits, followed by a 7-day observation period, elicited slight or
occasional moderate transient corneal opacity and iritis amongst the
animals during the first 24 hrs.. Slight or occasional moderate
conjunctival redness accompanied these changes for up to 72 hrs. All of
these changes were fully reversible within 7 days of instillation of the
test substance. In a similar more recent study (Safepharm Laboratories
Ltd., 1998), irritation responses, following instillation of 41mg of the
substance to a single eye of three rabbits, were limited to transient
conjunctival redness and chemosis for up to 48 hours.
The available animal test data are reliable and suitable for
classification purposes under regulation 1272/2008. The mean scores for
skin or eye irritation responses did not meet the EU CLP criteria for
classified of the substance as irritant.
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