Registration Dossier

Administrative data

Description of key information

Negative results from a modern, GLP-compliant, guideline guinea pig Maximisation test are pertinent to this endpoint.

Key value for chemical safety assessment

Skin sensitisation

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

The skin sensitisation potential of NExBTL renewable diesel was assessed in two GLP-compliant, guideline studies in the guinea pig (Maximisation test; method B6 of directive 96/54/EC) and the mouse (Local Lymph Node Assay; method B42 of Commission Directive 2004/73/EEC). Stimulation Indices greater than 3 were obtained in the LLNA, with borderline positive responses obtained also with kerosene and n-octadecane (two oily non-sensitising reference substances, tested undiluted). A satisfactory response was obtained with the positive control substance (a-hexyl cinnamaldehyde). According to interpretative criteria applicable to the LLNA method, the results suggest that NExBTL renewable diesel is a potential skin sensitiser, however an absence of chemical alerts in its structure together with the borderline positive findings obtained with the two non-sensitising reference substances strongly suggest the possibility of confounding. The result from the LLNA is therefore considered unreliable. In contrast, results obtained in the guinea pig Maximisation test were clearly negative, with a low incidence of transient slight or moderate erythema the only response present post-challenge. Again, a satisfactory response was obtained with the positive control group (a-hexyl cinnamaldehyde) in this study. Overall, the results demonstrate that NExBTL renewable diesel is not a skin sensitiser.


Justification for classification or non-classification

No classification required under Directive 67/548/EEC or Regulation EC 1272/2008 for skin sensitisation.