Registration Dossier

Diss Factsheets

Administrative data

Description of key information

An in vivo skin irritation study according to OECD TG404 was performed under GLP conditions with the substance and the Primary Irritation Index was determined to be 0.


Dapsone has long history of safe use as drug for dermal application in treating a wide range of dermal diseases (Wolf et al. 2002)


An in vitro eye irriation study (Bovine Corneal Opacity and Permeability, OECD TG 437) was also performed under GLP conditions and the GHS criteria for classification were not met.

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

Justification for classification or non-classification

Based on the above mentioned results the substance does not need to be classified according to CLP regulation (EC No. 1272/2008).