Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

An in vivo test data on the analogous substance, Distillates (petroleum), straight-run middle (EC: 265-044-7) showed no chromosome damage was observed in the bone marrow chromosome aberration test. This was supported by the in vivo micronucleus erythocyte test conducted using Distillates (petroleum), hydrotreated middle (EC: 265-148-2).

The in vitro gene mutation test show weakly positive results for Distillates (petroleum), hydrodesulfurized middle (EC: 265-183-3), however, due the highly sensitive nature of the mouse lymphoma study, producing false positives, these results are treated with caution. A modified Ames test conducted with Distillates (petroleum), hydrotreated middle (EC: 265-148-2) produced ambiguous results with or without metabolic activation (S9).

Renewable diesel is produced from straight run gas oil (corresponding to EC 265-044-7: considered non-carcinogenic) by hydrotreatment and except for the small excess of C17-C18 alkanes introduced as a consequence of soybean oil addition before hydrotreatment it corresponds to hydrotreated gas oil (EC 265-148-2). It has a ‘final boiling point’ of 346°C, a typical aliphatic hydrocarbon content around 80% and 0.5% - 1.4% (NOISE - SFC analysis) 3-ring Polycyclic Aromatics (no detected 4+-ring content). Based on all of the data discussed above, it is therefore predicted that Renewable Diesel would be negative (or at most give equivocal results) in the Ames test, would give either weakly positive or equivocal results in a mouse lymphoma cell mutation assay and would give negative results for chromosome damage in vivo. 

Short description of key information:
Several available studies on in vitro and in vivo genetic toxicity for substance analogous to Renew able Diesel

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results from in vivo genetic toxicity studies conducted with analogous substances, it is expected that Renewable Diesel will be non-mutagenic.