Raffinates (Fischer-Tropsch), C10-25-branched

Endpoint summary

Description of key information

Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401)
Acute Toxicity-Dermal LD50 > 5000 mg/kg in rabbits (OECD TG 402)
Acute Toxicity-Inhalation LC50 > 5000 mg/m3 (OECD TG 403)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Value:

mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Value:

mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Value:

mg/kg bw

Additional information

Read-across substances to Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, have been fully evaluated for acute toxicity.  All of the animal studies were performed in a manner similar or equivalent to currently established OECD guidelines.  Based on these data, Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, have a low order of acute toxicity by the oral, dermal, and inhalation routes of exposure.

Studies were available for acute oral toxicity, dealing with the toxicity of C5-C20 normal paraffins, C14-C17 n-alkanes, C14-C16 paraffins and isohexadecane. All studies were conducted similarly to OECD guideline 401 without GLP compliance. All studies show no mortality at concentrations up to 5000 mg/kg bw.

Studies were available for acute dermal toxicity, dealing with the toxicity of C5-C20 normal paraffins, C14-C17 n-alkanes and C14 -C16 paraffins. All studies were conducted similarly to OECD guideline 402 without GLP compliance. All studies show no mortality at concentrations equal to or higher than 5000 mg/kg bw.

Studies were available for acute inhalation, dealing with the toxicity of Hydrocarbons, C10-C12, isoalkanes, < 2% aromatics and C14-C16 n-paraffins, respectively. All studies were conducted similarly to OECD guideline 403. They all show no mortality at concentrations equal to or higher than 5000 mg/m3.

Justification for classification or non-classification

Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, is minimally toxic via ingestion where the LD50 is >5000 mg/kg, via dermal exposure where the LD50 is >5000mg/kg, and by inhalation where the LC50 > 5000 mg/m3.  These findings do not warrant classification of Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD). Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm2/s)and as an R65 aspiration hazard under the EU DSD/DPD.