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Carcinogenicity

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Description of key information

The available data and available weight of evidence demonstrate that the C14-20 Aliphatics (≤2% aromatic) are highly unlikely to be carcinogenic and are not classifiable as carcinogens.

Key value for chemical safety assessment

Additional information

The weight of evidence is derived from study records reported for the C14-20 Aliphatics (≤2% aromatic). C14-20 Aliphatics (≤2% aromatic) are not genotoxic and are not classifiable as mutagens based upon the results of reliable in vitro and in vivo studies. In bacterial reverse mutation studies, C14-20 Aliphatics (≤2% aromatic) were not mutagenic in the presence or absence of metabolic activation (IUCLID section 7.6.1). In mammalian cells in vitro, and in rats in vivo there were no mutagenic, clastogenic or aneugenic effects reported in read-across from studies on hydrodesulfurized kerosene kerosene, and jet fuels that included: a negative chromosome aberration (Human Peripheral Lymphocyte Chromosomal Aberration Test, Chinese Hamster Ovary Sister Chromatid Exchange Assay); and an in vivo inhalation exposure bone marrow chromosomal aberration study and micronucleus test in rats and mice (IUCLID sections 7.6.1 and 7.6.2).

Moreover, C14-20 Aliphatics (≤2% aromatic) hydrocarbon fluids are poorly absorbed if ingested. They undergo metabolism, rapid excretion and low deposition; bioaccumulation of the test substance in the tissues is not likely to occur. In addition, in repeat dose studies at levels up to 5000 mg/kg/day, there were no cumulative effects and no evidence of hyperplasia.

Justification for classification or non-classification

These findings do not warrant the classification of C14-20 Aliphatics (≤2% aromatic) as a carcinogen under the CLP Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures or under the Directive 67/548/EEC for dangerous substances.