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EC number: 931-082-4
CAS number: -
skin sensitisation potential of NExBTL renewable diesel (a UVCB
substance of similar composition to the substance: see analogue approach
justification document) 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 the read-across substance 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. By analogy, no sensitisation potential is expected for the substance
Migrated from Short description of key information:
Negative results from a modern, GLP-compliant, guideline guinea pig Maximisation test on NExBTL renewable diesel (a UVCB substance of similar composition to the substance) are pertinent to this endpoint.
No classification required under Regulation
EC 1272/2008 for skin sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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