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EC number: 203-347-8
CAS number: 105-95-3
7.3.2/1: Irritant/corrosive response data each animals at each
observation time up to removal from the test
Score at time point / Reversibility
0 / 0 / 0
2 / 1 / 1
1 / 1 / 1
1 / 0 / 0
0 / 0 / 1
Average 24h, 48h, 72h
0.3 / 0.3 / 0.7
Average time (unit) for reversion
Reversibility: c. = completely reversible; n.c. = not completely
reversible; n. = not reversible
In an eye irritation study performed
according to the OECD guideline No. 405, and in compliance with GLP, 0.1
mL of undiluted Ethylene Brassylate was instilled initially into the
right eye of a single New Zealand White rabbit. After consideration of
the ocular responses produced in the first treated animal, two
additional animals were treated. The eyes were not rinsed after
administration of Ethylene Brassylate. The left eye of each rabbit
served as control. Animals were observed 1, 24, 48 and 72 hours after
dosing under a light source from a standard ophthalmoscope. The
reactions in the conjunctiva (redness, chemosis and discharge), the iris
and the cornea (opacity and area involved) were scored according to the
No ocular irritation was noted in any animal
at the 72-Hour observation, therefore no further observations were
required and the study was terminated.
No corneal or iridial effects were noted
during the study. Moderate conjunctival irritation (grade 2) was noted
in one treated eye with minimal conjunctival irritation (grade 1) noted
in two treated eyes one hour after treatment. Minimal conjunctival
irritation (grade 1) was noted in all treated eyes at the 24-hour
observation and persisted in one treated eye at the 48-hour observation.
Two treated eyes appeared normal at the 48-hour observation and one
treated eye appeared normal at the 72-hour observation, therefore the
study was terminated on Day 3 post instillation.
Mean scores calculated for each animal over
24, 48 and 72 hours were 0.0/0.0/0.0 for cornea opacity, 0.0/0.0/0.0 for
iris lesions, 0.3/0.3/0.7 for redness of the conjunctivae and
0.0/0.0/0.0 for chemosis.
Under the test conditions, Ethylene
Brassylate is not classified as irritating to eyes according to the
criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and
of the Directive 67/548/EEC.
This study is considered as acceptable and
satisfies the requirement for eye irritation endpoint.
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