Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The skin sensitising potential of the test substance has been evaluated in a Guinea Pig Maximisation Test performed according to OECD 406 (Vohr, 2005). Test animals were treated with a suspension of 5% test substance by intradermal injection (20 mg test substance/animal). One week later, the test animals were treated with 50% test substance (250 mg test substance/animal) by epicutaneous application over the induction injection sites. The challenge dose was a 50% suspension (250 mg test substance/animal) applied by epicutaneous administration 2 weeks after the second induction. Following the first induction, the animals in the control group and the test group showed clear effects of irritation (encrustation) at the injection sites. The challenge with the 50% test substance formulation led to skin effects (grade 1) in 10 of 20 animals in the test group (incidence of sensitisation: 50%). This is above the 30% threshold for skin sensitisation potential, indicating that the test substance exhibits a skin-sensitising effect. No skin effects were observed in the animals of the control group. No systemic toxicity was noted during the observation period. Based on the results of the study, the test substance is considered to be a skin sensitiser (Category 1B according to CLP criteria).

Migrated from Short description of key information:
GPMT (OECD 406): sensitising

Justification for selection of skin sensitisation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data on skin sensitisation, the test substance needs to be classified according to the criteria of DSD (67/548/EEC) and CLP (1272/2008/EC):

DSD: R43

CLP: Skin sensitisation category 1B