Registration Dossier
Registration Dossier
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EC number: 249-978-2 | CAS number: 29964-84-9
Endpoint summary
Administrative data
Description of key information
Results of the repeated dose studies on the structurally closely related esters 2-Ethylhexyl methacrylate (C8-Ester) and Dodecyl methacrylate
(C12-Ester) are considered as representative for the repeated dose toxicity of Isodecyl methacrylate (C10-Ester).
In an OECD 422 GLP study with Dodecyl methacrylate in rats, there was no evidence for toxicity up to the highest administered dose.
The NOAEL was 1000 mg/kg/d. In a fully valid 90 d OECD 408 GLP study with 2-Ethylhexyl methacrylate, the NOAEL was 120 mg/kg body weight/day in rats.
Taken as a whole there are sufficient data available for assessment purposes so for the sake of animal welfare it is not proposed to conduct further
repeated dose studies.
Key value for chemical safety assessment
Additional information
For alkyl methacrylate esters in principal and especially for the structurally closely related esters 2-Ethylhexyl methacrylate and Dodecyl methacrylate, there is strong and consistent evidence for a uniform metabolism (Jones, 2002, cf chapter 7.1.1). The first step is always cleavage of the ester to methacrylic acid and the regarding alcohol catalyzed by unspecific esterases which are present in all tissues relevant for metabolism, including liver, skin and lung tissues. Thereafter, the acid is further metabolised via the valine pathway of the citric acid cycle and the alcohol may be further metabolised by the standard metabolic pathways for fatty alcohols. Consequently, results of the repeated dose studies on the structurally closely related esters 2-Ethylhexyl methacrylate (C8-Ester) and Dodecyl methacrylate (C12-Ester) are considered as representative for the repeated dose toxicity of Isodecyl methacrylate (C10-Ester).
In an OECD 422 GLP study with Dodecyl methacrylate in rats, there was no evidence for toxicity up to the highest administered dose.The NOAEL was 1000 mg/kg/d. In a fully valid 90 d oral toxicity GLP study in rats according to OECD 408, 2-Ethylhexyl methacrylate revealed signs of general systemic toxicity in male as well as female rats at a dose level of 360 mg/kg/d. The NOAEL was 120 mg/kg/d.
Taken as a whole there are sufficient data available for assessment purposes so for the sake of animal welfare it is not proposed to conduct further repeated dose studies.
Justification for classification or non-classification
According to the criteria as of directive 1272/2008/EC, no classification is warranted.
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