Registration Dossier
Registration Dossier
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EC number: 445-630-0 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The notified substance is a liquid with a low volatility. It
has a moderate solubility in water and a log Po/w of 0.83.
The notified substance also contains about 16 % of the
mono-acetate, which shows a higher solubility in water than
the diacetate and a log Po/w of 0.05.
Clear evidence for systemic availability of the notified
substance comes from the subacute toxicity study in rats
(BASF 2003). In this study with oral doses of 0, 50, 200,
and 800 mg/kg body weight (bw), clinical, clinico-chemical,
gross- and histopathological effects were observed at 200
and 800 mg/kg bw, beeing clear indicators of bioavailability of
the notified substance. The increase in relative liver
weights in female rats at 200 and 800 mg/kg bw together with
the increased g-glutamyltransferase activities in the serum
of the high dose females is indicative for a slight
induction of the microsomal enzyme system.
In an acute dermal toxicity study in rats, no signs of
toxicity were observed even at 2000 mg/kg bw (Eastman Kodak
1996). When compared to the acute oral toxicity study in
rats, in which an LD50 of 794 mg/kg bw was observed (Eastman
Kodak 1996), the results of the acute dermal toxicity study
imply that no toxicologically relevant amounts of the
notified substance penetrate through the skin.
Considering the chemical structure of the notified
substance, metabolism may consist of:
- ester hydrolysis leading to 1,2-dihydroxy-3-butene which
might undergo oxidative metabolism ultimately to CO2
- epoxidation of the double bond and subsequent hydrolysis by
epoxide hydrolase or conjugation with glutathione
- conjugation of the hydroxy-groups
All potential metabolites of the metabolic pathway described
above are more polar and more water soluble than the parent
and are expected to be excreted predominantly via the urine.
Taking into account the low log Po/w as well as the
considerations on the potential metabolism, accumulation of
the notified substance is considered to be unlikely.
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.
