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:

In this study the test item Pentaerythritol, olig. react. prod. with 1-chloro-2,3- epoxypropane, react. prod. with acrylic acid was assessed for its skin sensitizing potential using the Local Lymph Node Assay (LLNA, OECD 442B) in mice. Test item solution at different concentrations was prepared in the vehicle N, N-dimethylformamide (DMF).

A statistically significant increase in ear weights was observed in all doses groups, but was considered not to be biologically relevant.

In this study Stimulation Indices (S.I.) of 1.0, 1.1 and 1.9 were determined with the test item at concentrations of 5, 10 and 25 % (w/w) in N, N-dimethylformamide, respectively. Based on the S.I.s obtained with 10 and 25% test item concentration, an EC1.6 value of 19.38% (w/w) was calculated.A clear dose response was observed.

The test item Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid was found to be a skin sensitizer under the test conditions of this study.

Migrated from Short description of key information:
Skin sensitization: sensitizer (BASF SE, 2013 LLNA)

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EC: skin sensitization, R43

GHS classification (GHS UN rev.3, 2009): skin sensitization category 1B