Registration Dossier

Administrative data

Description of key information

In an EpiDerm™ Corrosivity-Test and a HET-CAM in vitro corrosion test it is concluded that the test substance is not corrosive to either skin and eye.

Key value for chemical safety assessment

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

The corrosive potential was determined in an EpiDerm™ Corrosivity-Test in vitro (BASF 2005). Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Tissue viability was determined after exposure to the test substance. This was decreased to 91% after 3 minutes exposure and to 27% after 1 hour exposure. Based on this the test substance was considered to be non-corrosive.

Eye irritation

The potential to cause serious eye damage was determined in the HET-CAM in vitro corrosion test (alternative method to study the potential of serious damage to the eyes/mucous membranes in incubated hen eggs) (BASF 2005). Three hen eggs were exposed to the undiluted test substance or 10% water solution for 210 seconds. Moderate coagulation effects were observed in eggs exposed to the undiluted test substance. No changes indicative for serious eye damage were observed.


Justification for selection of skin irritation / corrosion endpoint:
One skin corrosion in vitro study available. This study provides information that the substance is not corrosive. Information about skin irritation is however not available.

Justification for selection of eye irritation endpoint:
One in vitro study on eye damage is available. This study provides information that the substance does not cause serious eye damage. Information about eye irritation is however not available.

Justification for classification or non-classification

Based on the findings in the skin and eye corrosion study ethylenediamine p-toluenesulphonate this substance is considered to be not corrosive. However, no information is available on the irritating properties of the test substance. As a worst case assumption the substance was classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 as eye irritant Category 2: H319 Causes serious eye irritation and H315: Causes skin irritation as well as Xi: R36/38 Irritating to eyes and skin according to the Directive 67/548/EEC (DSD).