Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There are no data on sensitisation with disulfiram. Therefore, its sensitisation potential is assessed using read-across from a study conducted with the surrogate substance, thiram (CAS 137 -26 -8). (For detailed information on the justification of read-across, please refer to the analogue justification document attached in IUCLID section 13).

One reliable animal sensitisation study performed according to EPA-OPP 81-6 (Split Adjuvant Test) is available for thiram (Weterings, 1985). A 25% dilution of the substance caused sensitisation in 8/20 female guinea pigs 24 hours after challenge. No irritation was observed in the animals.

Patch testing in sensitised humans, the pure substance induced a reaction, while the substance formulated into rubber did not cause any effects (Crabtree, 1978).

Migrated from Short description of key information:

Read-across from thiram: Sensitising to skin.

Justification for classification or non-classification

The substance is classified as sensitising to the skin Xi, R43 and Category 1, according to EU Directive 67/548/EEC and the CLP Regulation, respectively.