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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Repeated Dose Oral 90d – NOAEL >=5000 mg/kg for rats (similar to OECD TG 408)
Repeated Dose Inhalation 90d – NOAEL >= 10400 mg/m3 for rats (similar to OECD TG 413)
Repeated Dose Dermal 90d – NOAEL >=495 mg/kg for rats, highest dose tested (similar to OECD TG 410)

Key value for chemical safety assessment

Additional information

Oral:  Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, are expected to have a low order of repeated dose toxicity by the oral route of exposure.  All tests were performed in a manner similar or equivalent to currently established OECD guidelines. In a repeated dose study where read-across substances were administered via oral gavage, no signs of toxicity were observed at the maximum experimental dose tested, 5000 mg/kg/day.

Inhalation: In a repeated dose study where read-across substances were administered via inhalation, no signs of toxicity were observed at 10400 mg/m3. Based on these observations, the repeat inhalation concentration NOAEL is >=10400 mg/m3 (10.4 mg/L) for Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids. 

 

Dermal: Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, 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, 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. In a repeated dose study where hydrodesulfurized kerosene was administered via semi-occlusive patch, the systemic NOAEL was determined to be >=495 mg/kg/day, which was the highest dose tested.

Justification for classification or non-classification

These findings do not warrant the classification of Raffinates (Fischer-Tropsch), C10-C25-branched hydrocarbon fluids, 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 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.