Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 618-882-6
CAS number: 928771-01-1
The reproductive toxicity of NExBTL
renewable diesel was examined in the rat following oral gavage
administration over two consecutive generations at dose levels of 50,
250 and 1000 mg/kg/day. The study, which was GLP-compliant and included
a sub-chronic reproductive toxicity phase, followed OECD guideline 416.
Clinical signs were limited to salivation following dosing in the high
and intermediate treatment groups which also showed increased water
intake; both findings were considered secondary to the unpleasant taste
of the test substance formulations.
Oestrus cycle, mating cycle and pre-coital
intervals were comparable in control and parental animals although a
non-significant increase in non-pregnant females was observed in the
P-generation at 1000 mg/kg/d and 250 mg/kg/d. The study was therefore
extended to include a second generation which showed a non-significant
increase in fertility (all treated groups) when compared to controls. It
was therefore concluded that the finding from the first generation was
not indicative of an adverse effect on reproduction.
There was no statistically significant or
treatment related effect on number of corpora lutea, implantation sites
or number of live births in either generation although mean litter size
for the intermediate and high dose groups from both P and F1 generations
was approx. 8-10% lower than controls; this finding was not
statistically significant and considered of negligible toxicological
No gross malformations attributable to
treatment were present in the off-spring. Ano-genital distance in F2
generation animals was unaffected by treatment.
Semen analysis for males from both
generations and ovarian follicle development for F1 generation females
Liver and kidney weights were elevated for
high and intermediate males from both generations with treatment-related
effects observed microscopically. Hepatic findings consisted of
generalised hepatocyte enlargement for females treated with 1000 and 250
mg/kg/day from the P generation, and for animals of either sex treated
with 1000 mg/kg/day from the F1 generation. Hepatocyte enlargement is
commonly observed in the rodent liver following the administration of
xenobiotics and considered to be adaptive in nature. Renal changes were
characterised as globular accumulations of eosinophilic material in the
tubular epithelium of males treated with 1000 and 250 mg/kg/day from
both the P and F1 generations. This finding appeared consistent with
alpha-2-microglobulin accumulation and was confirmed by the additional
staining with Mallory-Heidenhain stain. Alpha-2-microglobulin is absent
from humans and the findings were therefore viewed of negligible
It was concluded that oral administration of
NExBTL renewable diesel to rats throughout the reproductive cycle over
two generations at dose levels of up to 1000 mg/kg/day did not result in
any toxicologically significant effects with an overall NOAEL of 1000
mg/kg bwt/d for reproductive and systemic toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again