Registration Dossier

Administrative data

Description of key information

Skin irritation (comparable to OECD 404): not irritating.

Eye irritation (Draize method): not irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

There are reliable studies on skin irritation with the test substance disulfiram. However, since the available data have restrictions, all available information will be used in a weight of evidence to assess the irritation potential of disulfiram. In a study addressing skin irritation, rabbits were exposed to undiluted disulfiram for 4 hours under occlusive conditions (Guillot et al., 1982). Only very slight irritating properties were noted (PDII = 0.13), no information on the reversibility is given. When disulfiram was tested both on intact and abraded skin similar to OECD 404, the substance was not irritating (Branch, 1983c).

A primary eye irritation study was performed similar to OECD Guideline 405 to assess the irritation potential of disulfiram (Branch, 1983d). The eyes of six New Zealand White rabbits were treated with the unchanged test material by single instillation. The eye reactions were recorded according to Draize scores (Draize 1944). Only one out of 6 animals showed remarkable conjunctival reactions at the 24 hour reading. All findings were fully reversible within 7 days. Thus, the test substance was found to be not irritating to the rabbit eye in vivo.

 

Justification for classification or non-classification

The available data on skin and eye irritation are conclusive but not sufficient for classification according to Directive 67/548/EEC and the CLP Regulation.