Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-657-1 | CAS number: 3179-47-3
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 n-Decyl methacrylate (n-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
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 120 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The weight of evidence study is GLP compliant, guideline study (OECD 408) and of high quality (Klimisch score = 1).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 n-Decyl methacrylate (n-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 selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study with the longest duration (90-days) and lowest NOAEL was chosen (weight of evidence study).
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
No reliable data are available on n-Decyl methacrylate for the inhalation route. Acute toxicity studies of the structurally closely related Isodecyl methacrylate demonstrate low toxicity by all routes of exposure. Due to the low vapour pressure which is about 0.0127 hPa (at 20 °C) , it is very unlikely that toxic concentrations could ever be reached in the air at the workplace. Hence, the inhalation pathway is not considered a relevant route of exposure.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
No reliable data are available on n-Decyl methacrylate for the inhalation route. Acute toxicity studies of the structurally closely related Isodecyl methacrylate demonstrate low toxicity by all routes of exposure. Due to the low vapour pressure which is about 0.0127 hPa (at 20 °C) , it is very unlikely that toxic concentrations could ever be reached in the air at the workplace. Hence, the inhalation pathway is not considered a relevant route of exposure.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Reliable repeated dose toxicity studies are available by the oral route.
Justification for classification or non-classification
According to the criteria as of directive 1272/2008/EC, no classification is warranted.
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.
