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EC number: 618-882-6
CAS number: 928771-01-1
No biologically or toxicologically relevant findings in a GLP-compliant guideline study up to an oral limit dose of 1000 mg/kg bwt/d
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.
study was conducted to achieve compliance under chemical, safety and
health regulations other than EU REACH.
No classification required under Directive
67/548/EEC or Regulation EC 1272/2008 for repeated dose toxicity
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