Registration Dossier
Registration Dossier
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EC number: 941-650-3 | CAS number: -
Neurotoxicity
Administrative data
Description of key information
Based on read-across using the analogue approach, Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics are not considered to be neurotoxic.
Subacute, 7d, rat, dermal: NOAEL ≥ 2000 mg/kg
Key value for chemical safety assessment
Effect on neurotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
Additional information
There are no data available on neurotoxicity of Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics.
Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics consist of hydrocarbon solvents with predominant carbon numbers in the range of C11 to C19. The constituents of this solvent are single isomers as well as mixed solvents of which the primary constituents are branched chain (iso-), and cyclic aliphatic hydrocarbons. Aromatic constituents, if present, represent less than 0.1% of the total volume.
N-paraffins are only present in very low concentrations (<1%).
The carbon numbers in the range of C11 to C19 and initial distillation points (IBP) characterize the source substances. The distillation range of the source substances ranges from 220°C to 350 degree Celsius although some solvents may contain higher boiling material. The benzene and sulphur contents of source substances are low, benzene levels for example are typically <3 ppm.
The toxicology and environmental fate and effects data show that source substances have a similar order of (eco-)toxicological and environmental fate properties as the target substance. Therefore, read-across is performed based on an analogue approach (for details please refer to the analogue justification which is attached in section 13 of the technical dossier).
The study of ExxonMobil (1993) was conducted to assess the systemic toxicity of repeated topical application of hydrocarbons, C11-C14, n-alkanes, < 2% aromatics. Four groups consisting of 2 rabbits/sex/group were used. The test substance was dermally applied to the animals at dose levels of 500, 1000, and 2000 mg/kg for 7 days. The control group was treated with n-hexane. Dermal application of 2000 mg/kg of the test substance for 7 days did not cause any gross signs of neurotoxicity or any clinical signs except for skin irritation, with erythema ranging from very slight to severe. All animals survived to study termination. Based on these results, the NOAEL was ≥ 2000 mg/kg bw/day.
Justification for classification or non-classification
Based on the read-across within an analogue approach, the available data on neurotoxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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