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EC number: 267-007-0
CAS number: 67762-26-9
This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid methyl ester and SDA Reporting Number: 04-010-00.
Four groups of 10 male and 10 female
Sprague-Dawley rats were dosed orally by gavage once daily at levels of
0, 100, 300 and 1000 mg/kg/day. The vehicle was corn oil. The males were
treated for 2 weeks prior to mating, through until necropsy after at
least 4 weeks of treatment. Females were treated for 2 weeks prior to
mating, then through mating, gestation until at least Day 4 of lactation
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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