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Table 7.3.1/1:Irritant/corrosive response data at each observation time after each exposure time.
Score at time point (from the start of exposure) / Reversibility
Max. score: 4
Average 24h, 48h, 72h
Average time (day) for reversion**
*) Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible
**) Corresponds to the last day on which skin irritation signs in the last animal were observed
In a dermal irritation screening study performed similarly to the OECD guideline No. 404, one New Zealand White rabbit was dermally exposed to 0.5 mL of undiluted Dermalcare MAP L-213/K on a part of the trunk (6.25 cm²).Test site was covered with a semi-occlusive dressing for 4hours. The animal was then observed for 7 days. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.
The mean score calculated within 3 scoring times (24, 48 and 72 hrs) was 2.0 for erythema and 0.0 for edema.
Under the test conditions, Dermalcare MAP L-213/K was irritating to the rabbit skin. The mean erythema score (2.0) obtained in the only one tested rabbit (screening test) do not permit to classify Dermalcare MAP L-213/K as a skin irritant according to the criteria of the Regulation (EC) 1272/2008 (CLP) but permit to classify as Xi, R38 according to the criteria of the Directive 67/548/EEC.
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