Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

Skin irritation

In a recent in vitro skin irritation study the test item showed a mean relative tissue viability of 88.1%.

The test item is considered irritant to the skin if the mean relative tissue viability of three individual tissues is reduced ≤ 50% of the negative control. Thus, based on the available data on skin irritation, the test item does not meet the criteria for classification according to Regulation (EC) 1272/2008 (CLP).

Eye irritation

In a recent in vitro eye irritation study (BCOP) the 3 corneas treated with the test item showed intense opacity and a rose discolouration of the tissue. The following mean in vitro irritation score was calculated: 95.93

It cannot be excluded that the high opacity score may be related to the rose discoloration of the tissue but due to the observed intense opacity of the treated corneas and the high rate of the score, an eye irritancy potential of the test item is assumed.

Based on the available data on eye irritation, the test item meets the criteria for classification according to Regulation (EC) 1272/2008 (CLP) as Eye damage, category 1.