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Administrative data

Description of key information

Equivalent to OECD dermal carcinogenicity study, GLP compliant, on analogous substance Distillate (Petroleum), hydrotreated middle.

Key value for chemical safety assessment

Justification for classification or non-classification

Thus Renewable Diesel should not be classified as carcinogenic under 67/548/EEC or CLP regulation (1272/2008), being produced from non-carcinogenic feedstock, having a very low mutagenic/carcinogenic polycyclic aromatic (3+/4+ ring) content and closely resembling gas oil samples shown to be non-carcinogenic or at most locally-acting, non-genotoxic carcinogens via a repetitive wounding mechanism.

Additional information

In a 2 year dermal carcinogenicity study conducted on an analogous substance (Distillates (Petroleum), hydrotreated middle) using mice, there was a clear link between degree of dermal irritation and localised tumour formation. The two lower doses tested (28.5% and 50%) which produced less severe dermal irritation did not produce statistically significant increases in the number of skin tumours compared with the control group.

Based on the results of this study, it is predicted that prolonged and repeated application of undiluted material (Renewable Diesel) to the skin would prove highly irritating: over the lifespan of a rodent: the consequent skin damage is likely to prove sufficient to cause localised tumours through a non-genotoxic, repetitive skin insult mechanism. However distant tumours would not be expected.