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EC number: 618-882-6
CAS number: 928771-01-1
Negative results from a modern, GLP-compliant, guideline guinea pig
Maximisation test are pertinent to this endpoint.
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
No classification required under Directive
67/548/EEC or Regulation EC 1272/2008 for skin sensitisation.
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