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EC number: 944-817-9
CAS number: 244626-73-1
7.3.1/1: Mean irritant/corrosive response data for each animals at each
observation time up to removal of animals from the test
Score at time point / Reversibility
Max. score 4
Average 24h, 48h, 72h
14 d ($)
Average time (day) for reversion**
Reversibility: c. = completely reversible; n.c. = not completely
reversible; n. = not reversible
correspond to the last day for which skin irritation signs in the last
animal were observed
desquamation was observed
desquamation and skin thickening
($) = seven
day after dosing there were no sign of either erythema or edema at the
appllication site of the rabbit used in the preliminary screen and
observations of this rabbit were discontinued at this stage.
a dermal irritation study performed according to the EU B.4 test method
and in compliance with GLP, 0.5 mL of undiluted test material was
dermally applied on the clipped skin of the dorsal surface of the trunk
of 4 New Zealand White rabbits.Test sites were covered with a
semi-occlusive dressing for 4 hours. Animals were then observed for 14
days for oedema and erythema.
irritation was assessed and scored according to the Draize scale at 1,
24, 48 and 72 h after the removal of the patch. Additional assessments
were carried out 7 and, in the last 3 animals dosed, 14 days after
dosing to determine the degree of reversibility of the skin reaction.
mean scores calculated for each animal tested within 3 scoring times
(24, 48 and 72 h) were 1.33/2.67/3.00/2.67 for erythema and
1.67/2.33/3.00/1.67 for oedema.
hour after the end of the dosing period, oedema was noted at the
application site in 2 animals and, in one rabbit, this was accompanied
by slight erythema. Twenty-four
hours after patch removal, erythema ranging in intensity from slight to
moderate, accompanied by slight to moderate oedema, was apparent at the
application site in all 4 animals. Over the next 24 hours these skin
responses generally increased and, by the 72 hour observation, erythema
was evident in 3 animals and well defined in the fourth. The intensity
of the oedematous reaction varied from slight to moderate. Seven days
after dosing, there was no sign of either erythema or oedema at the
application site of the rabbit used in the preliminary screen and
observations on this rabbit were discontinued at this stage. In the
remaining 3 animals, well defined erythema and slight to moderate oedema
were still apparent. Desquamation was noted at the application site in
all 4 rabbits. Fourteen days after dosing, oedema was no longer apparent
in any animal. Well defined or moderate erythema was noted in the 3
remaining animals and skin thickening and/or desquamation was observed
at the application site in all these animals.
under the test conditions, the test material is classified as:
irr. Category 2 (H315: Causes skin irritation) according to the Annex VI
of the Regulation (EC) No. 1272/2008 (CLP).
study is considered as acceptable and satisfies the requirement for skin
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