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Description of key information

Repeated Dose Oral 30d – NOAEL 1056 mg/kg for rats (similar to OECD TG 408); highest dose tested; read-across test material Hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics, 2-25%

Repeated Dose Dermal 90d – NOAEL 495 mg/kg for rats, highest dose tested (similar to OECD TG 410)

Repeated Dose Inhalation 90d – NOAEL 690 ppm for rats (similar to OECD TG 413)

Key value for chemical safety assessment

Additional information

Oral: C14-C20 aliphatics, 2-30% aromatics are expected to have a low order of repeated dose toxicity by the oral route of exposure. No study was located for the test substance C14-C20 aliphatics, 2-30% aromatics, however, available read-across data from the hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics, 2-25% was analyzed. All tests were performed in a manner similar or equivalent to currently established OECD guidelines. The key study examined the oral 30 -day subchronic toxicity of hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, aromatics, 2-25% to rats (DHC Solvent Chemie GmbH 1984a). Groups of 5 rats of each sex were given doses of 116 mg/kg, 347 mg/kg, or 1056 mg/kg of test substance in corn oil for 30 days. Animals were examined for clinical signs, mortality, body weight, food consumption, water consumption, and food conversion. After sacrifice clinical chemistry, hematology, clinical chemistry, urinalysis, organ weights, histopathology, and gross pathology were examined. There was no mortality during the experiment. Renal damage was observed in male rats at all dose levels. This type of renal pathology is specific to male rats due to a alpha2u-globulin-mediated process that is not relevant to humans. Female rats exhibited minimal liver changes at the highest dosage. The LOAEL for male rats was 0.14 ml/kg/day based on renal damage. The female NOAEL was 1056 mg/kg; the highest dose tested. 

 

Dermal: C14-C20 aliphatics, 2-30% aromatics are expected to have a low order of repeated dose toxicity by the dermal route of exposure. No study was located for the test substance C14-C20 aliphatics, 2-30% aromatics, however, available read-across data from the structurally analogous test material hydrodesulfurized kerosene was analysed. All tests were performed in a manner similar or equivalent to currently established OECD guidelines. Test material was applied at concentrations of 165, 330 or 495 mg/kg/dayAmerican Petroleum Institute (2003). Dosing was continued daily for five consecutive days each week, five days a week for 13 weeks. In addition a group of 12 male and 12 female rats of similar age was administered mineral oil as vehicle controls and an additional high dose group was maintained for a 4-week recovery period following dosing for 13 weeks. At the 14 week necropsy, blood samples were collected from 12 animals/sex/group and at the week 18 necropsy from the recovery rats (vehicle and high dose groups). There were no systemic or neurological effects noted at any of the tested doses. The systemic NOAEL was 495 mg/kg/day. Since no effects were seen at the highest dose tested, a dermal DNEL will be calculated using route to route extrapolation using the key study identified for the oral route.

 

Inhalation: C14-C20 aliphatics, 2-30% aromatics are expected to have a low order of repeated dose toxicity by the inhalation route of exposure. No study was located for the test substance C14-C20 aliphatics, 2-30% aromatics, however, available read-across data from the structurally analogous test material C9-C12 aliphatics, 2-25% aromatics was analysed. The key study evaluated the subchronic toxicity of low aromatic white spirits to rats when exposed via inhalation Shell (1980). Groups of 18 rats per sex were exposed to 345, 690, or 1293 ppm of test substance for 6 hrs/day, 5 days/week, for 13 weeks. The highest concentration, 1293 ppm, was near the saturation point for test substance vapor. Rats were observed for clinical signs, mortality, food consumption, water consumption, and body weight. At the end of the exposure period, the animals were sacrificed, and clinical chemistry, hematology, gross pathology, and histopathology parameters were examined. Male rats at all exposure levels had degenerative effects of the as a result of an alpha2u-globulin-mediated process that is not regarded as relevant to humans. The LOAEC was established at 1293 ppm (7400 mg/m3) due to a significant body weight reduction. No other effects were noted. The NOAEC for female rats was 690 ppm (3950 mg/m3).  

Justification for classification or non-classification

These findings do not warrant the classification of C14-C20 aliphatics, 2-30% aromatics as a repeated dose toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.