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EC number: -
CAS number: -
Three well conducted oral studies up to 90 day duration were conducted
with the registration substance. The NOAEL was the limit dose of 1000
mg/kg/day in all three studies.
The most appropriate route of exposure for hazard evaluation is the oral
route as this is where the systemic dose will be highest. Exposure via
inhalation is not considered to be of importance because the substance
is non-volatile. Furthermore, the substance is used under industrial
conditions where correct training and strict adherence to PPE and
general risk management measures is expected. Additional testing is
therefore contraindicated on the grounds of animal welfare and lack of
probable exposure via the inhalation route.
The test substance is of relatively large molecular weight and it's
PChem properties (high Log Kow) dictate that absorption through unbroken
skin will be negligible. Furthermore, the substance is used under
industrial and professional conditions where correct training and strict
adherence to PPE and risk management measures are expected. The most
appropriate route of exposure for hazard evaluation is therefore likely
to be the oral route, as this will result in the greatest systemic dose.
analyzed dosing formulations were within WIL Research’s SOP range for
suspensions (85% to 115%) and were homogeneous. The
test substance was not detected in the vehicle formulation that was
administered to the control group.
was administered by daily oral gavage during 28 days to Crl:CD
rats (5/sex) at dose levels of 0, 100,
1000 mg/kg/day, according to OECD guideline 407.
There were no test substance-related deaths. Body weight, food
consumption, functional observational battery, locomotor activity,
hematology, coagulation, serum chemistry, and urinalysis parameters were
unaffected by test substance administration. There were no test
substance-related gross necropsy observations or histologic changes.
Test substance-related clinical observations of clear material
around the mouth were noted in the 1000 mg/kg/day group males and
Test substance-related higher liver weights were noted in the 1000
mg/kg/day group males and females and a lower seminal vesicles weight
was noted in the 1000 mg/kg/day group males. These observations were not
accompanied by histopathological changes, and considered to be not
on the results of this study, the
NOAEL was considered to be 1000 mg/kg/day, the highest dosage level
The test substance was administered by daily oral gavage during 90 -day
to Crl:CD (SD) rats (10/sex) at dose levels of 0, 100, 300 or 1000 mg/kg
There were no test substance-related deaths. Body weight (gain), food
consumption, FOB, opthalmoscopy and clinical biochemistry were
unaffected by test substance administration.
Test substance-related clinical observations of clear and/or red
material on various body surfaces (mouth, nose, and/or ventral neck)
were noted in the 300 mg/kg/day group males and in the 1000 mg/kg/day
group males and females.
Females at 1000 mg/kg bw/day showed statistically significantly lower
mean AST values (68% of control value). The mean ALT value at 1000 mg/kg
bw/day was also lower than the control group (56% of control), but this
difference was not statistically significant. Although the lower
AST and ALT values in the 1000 mg/kg/day group females were potentially
test substance-related, the mean values for these AST and ALT
differences in the test substance-treated groups were all within the WIL
Research historical control range and are considered not toxicologically
Test substance-related higher mean absolute and relative (to final
body weight and brain weight) liver weights were noted in the 1000
mg/kg/day group males and females. However, the only statistically
significant difference was mean liver weight relative to final body
weight in the 1000 mg/kg/day group males (110% when compared to
controls). This significantly higher mean relative
liver weight was within the WIL Research historical control range. All
other increases in absolute or relative liver weight remained below 110%
of controls. These weight changes were considered borderline effects, as
liver hyperthrophy was seen only (inherent to increased liver weight)
and the changes were not accompanied by adverse histopathological
Based on the results of this study, the NOAEL was considered to be
1000 mg/kg bw/day, the highest dose level administered.
The studies provide sufficient information of lack of hazard at maximum
experimental levels (1000 mg/kg/day). Since the registration substance
is meant to be used as a lubricant additive with no other possible use,
the information is sufficiently protective for humans.
Not classified in accordance to Regulation (EC) No 1272/2008 since no
adverse effects were noted up to a limit dose of 1000 mg/kg/day in all
three studies, including a sub-chronic 90 day repeated dose 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.
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