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EC number: 944-817-9 | CAS number: 244626-73-1
Table 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 ($)
Average time (day) for reversion**
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**): correspond to the last day for which skin irritation signs in the last animal were observed
a = desquamation was observed
b = desquamation and skin thickening
($) = 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.
In 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.
Skin 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.
The 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.
One 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.
Therefore, under the test conditions, the test material is classified as:
- Skin irr. Category 2 (H315: Causes skin irritation) according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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