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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

90 day repeated dose oral toxicity study in the rat: 
- treatment-related effects in animals of either sex treated with 1000 and 200 mg/kg/day
- no such effects were detected in animals of either sex treated with 50 mg/kg/day and the “No Observed Effect Level” (NOEL) was, therefore, considered to be 50 mg/kg/day
- the effects detected at 200 and  1000 mg/kg/day in the lungs and mesenteric lymph nodes were considered to be secondary to aspiration following the oral gavage and a normal response of the lymph nodes clearing the material, respectively, and were therefore  not considered to be an adverse effect of treatment; the “No Observed Adverse Effect Level” (NOAEL) was therefore considered to be 1000 mg/kg/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The oral administration of ‘Distillates (Fischer-Tropsch), heavy, C18-50-branched, cyclic and linear’ to rats for a period of ninety consecutive days at dose levels of 50, 200 and 1000 mg/kg/day in an OECD 408 study resulted in treatment-related effects in animals of either sex treated with 1000 and 200 mg/kg/day. The “no observed effect level” (NOEL) was considered to be 50 mg/kg/day. However the effects detected at 200 and 1000 mg/kg/day in the lungs and mesenteric lymph nodes were considered to be secondary to aspiration following the oral gavage and a normal response of the lymph nodes clearing the material, respectively, and were therefore not considered to be an adverse effect of treatment. The “No Observed Adverse Effect Level” (NOAEL) was therefore considered to be 1000 mg/kg/day.

Justification for classification or non-classification

Based on the absence of significant effects for human health in the available sub-chronic toxicity study on GTL Base Oil Distillates, there is no requirement to classify for specific target organ toxicity following repeated exposures, according to the criteria of Regulation 1272/2008/EC.