Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A skin sensitisation test was conducted at (Pharmakon Europe, 2001) for T-1540N. The skin sensitisation test was performed by the Buehler method, and according to OECD Test Guideline 406. 20 Guinea pigs were treated dermally with T-1540N in absolute ethanol paste ( test article 0.1% (w/w) suspension in absolute ethanol) at a dose level of 50% (w/w) paste in absolute ethanol. A concurrent control group was exposed to untreated vehicle during the induction phase.

No animals showed signs of sensitisation following the challenge exposure.


Migrated from Short description of key information:
Skin sensitisation, guinea pigs - not sensitising (0 positive responses out of 20 guinea pigs tested).

Justification for classification or non-classification

In a skin sensitisation test conducted in guinea pigs, no animals (out of 20 tested) were found to exhibit signs of sensitisation. On this basis, it is concluded that T-1540N does not meet the criteria for classification as a skin sensitiser.

No data was available regarding respiratory information for T-1540N