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EC number: 273-606-8
CAS number: 68990-52-3
NOAEL subcronic toxicity rat = 1000 mg/kg bw/day
A total of
80 rats (40 males and 40 females) Sprague-Dawley rats,Crl CD® (SD)were
allocated to four groups, three of which received the test item,
Heptadecanoic Fatty Acid Methyl Ester (C16-C18)
while the other group received the vehicle (corn oil) by oral route
(gavage) once daily under a dosage volume of 5 mL/kg. Animals will be
dosed for 2 weeks prior to pairing, during pairing, during gestation and
until at least day 4 post-partum for females or until sacrifice
for non pregnant females and until necropsy for males following 4 weeks
following dose-levels were used:
. Group 1
(10 males and 10 females): 0 mg/kg/day,
. Group 2
(10 males and 10 females):100mg/kg/day,
. Group 3
(10 males and 10 females):300mg/kg/day,
. Group 4
(10 males and 10 females):1000mg/kg/day.
A sub-chronic toxicity study (90 days) is
not proposed by the registrant because the frequency and duration of
human exposure indicates that a longer term study is not appropriate;
the exposure to the substance is likely in the working scenario, where
exposure of worker to biodiesel is pertinent only for accidental dermal
route, and RMM are already applied. Inhalation route is not considered
due to the physical chemical properties of the substance.
Furthermore the substance don't have
dangerous properties that cannot be detected in a short-term toxicity
study; accumulation of the substance or its metabolites in certain
tissues or organs which would possibly remain undetected in a shortterm
toxicity study don't are liable to result
in adverse effects after prolonged exposure. They enter in the endogen
metabolism of fatty acids and fatty acid methyl esters that can be
accumulated or released by tissues on demand.
A NOAEL can be established because of the
absence of adverse effect both in 28 and 90 days. Route to route
estrapolation can be done from oral to dermal.
Classification for STOT is relevant
where significant toxic effects are seen from single or repeated dose
studies. No such significant toxicity is seen in all available studies
No classification for STOT is
warrented at present under 67/548/EEC or Regulation 1272/2008.
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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