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Administrative data

Description of key information

No biologically or toxicologically relevant findings in a GLP-compliant guideline study up to an oral limit dose of 1000 mg/kg bwt/d

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

Results from repeated dose oral toxicity testing of NExBTL renewable diesel indicated negligible effects in male and female Wistar rats following gavage administration of 50, 250 or 1000 mg/kg bwt/d for up to 18 wk. Treatment-related clinical signs were limited to increased salivation following treatment, an observation presumed to reflect the unpleasant taste of the test substance. Observations for neuro-functional and neuro-behavioural toxicity together with determinations of haematological and clinical chemistry parameters were unremarkable. Histopathological findings were limited to an increased occurrence of generalised hepatocyte enlargement (a spontaneous finding, seen occasionally among untreated rats) in females from the high and intermediate dose groups while kidney tissue from high dose males exhibited globular accumulations of eosinophilic material in the tubular epithelium, shown to contain a2-microglobulin (Mallory-Heidenhain staining). The microscopic appearance of a wide range of other tissues was unremarkable. The changes recorded at 1000 and 250 mg/kg/day were considered not to represent an adverse health effect giving a No Observed Adverse Effect Level for systemic and neuro-functional/neuro-behavioural toxicity of 1000 mg/kg/day.

No information is available on the possible effects of repeated dermal or inhalation exposure to NExBTL renewable diesel, however these information requirements are waived in accordance with column 2 of REACH Annex VIII (8.6.1 and 8.6.2). Results from the available repeated dose oral toxicity study described above will be used to derive a NAEL and DNEL for dermal and inhalation exposures.

The study was conducted to achieve compliance under chemical, safety and health regulations other than EU REACH.

Justification for classification or non-classification

No classification required under Directive 67/548/EEC or Regulation EC 1272/2008 for repeated dose toxicity