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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In a Local Lymph Node assay that was conducted under GLP and according to OECD TG 442B, the test substance (+)-Pseudoephedrine was found to possess skin sensitizing properties. Since the maximum technically feasible concentration (25 %) was found to cause skin irritaions in the pretests, the main study was conducted using 2.5, 5 and 10 % of the test item in propylene glycol. No mortality was noted and no signs of systemic toxicity in any mouse.

The Stimulation Indices (S.I.) of 1.2, 1.7 and 3.1 were determined with the test item at concentrations of 2.5, 5 and 10 % (w/w) in propylene glycol. The Stimulation Indices (S.I.) of 1.2, 1.7 and 3.1 were determined with the test item at concentrations of 2.5, 5 and 10 % (w/w) in propylene glycol. Based on the S.I.s obtained with 2.5 and 5% test item concentration, an EC1.6 value of 4.5% (w/w) was calculated. A clear dose response was observed.

Therefore, (+)-Pseudoephedrine needs to be considered as skin sensitizer.

Migrated from Short description of key information:
LLNA (OECD TG 442B, GLP): sensitizing

Justification for classification or non-classification