Registration Dossier
Registration Dossier
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EC number: 221-657-1 | CAS number: 3179-47-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Methacrylates behave as a chemical family when studied for genotoxicity potential and, with few exceptions based on alerting chemical structures, new compounds in this family may be considered for waiver from acutal testing based on structure-activity relationships. Therefore the genotoxic behaviour of a similar chemical can be predicted with confidence by inclusion within this chemical class, thus avoiding unnessary testing. (Johannsen FR et al.(2008) Regulatory Toxicology and Pharmacology 50: 322 - 335)
There is only one in vitro mutagenicity study concerning the mutagenic potential for n-Decyl methacrylate available where n-Decyl methacrylate was negative in vitro (Ames test, Zeiger et al., (1987)). The results of genetic toxicity studies of the structurally closely related Isodecyl methacrylate (i-C10-Ester) and Dodecyl methacrylate (C12-Ester) are considered to be representative for the genetic toxicity of n-Decyl methacrylate (n-C10 -Ester).
n-Decyl methacrylate was negative in gene mutation test in bacteria according to the Ames test similar to OECD 471, non GLP (Zeiger et al., (1987). The structural analogue Isodecyl methacrylate showed also negative results in gene mutation tests in bacteria (Ames-Test, OECD 471, GLP) as well as in mammalian cells (HPRT-Test, OECD 476, GLP). No clastogenicity occurred in a chromosome aberration study (OECD 473, GLP).
In conclusion, Isodecyl methacrylate did not reveal any mutagenic potential. So we expect n-Decyl methacrylate to be none mutagenic as well. This is also supported by the in vitro Ames test with n-Decyl methacrylate.
Justification for selection of genetic toxicity endpoint
Only one study on n-Decyl methacrylate available, but supported by three other studies of structurally closely related substance Isodecyl methacrylate. Furtherrmore one in vivo study on the structurally closely related Dodecyl methacrylate exsits, which was negative too. No study was selected, since all in vitro studies were negative.
Short description of key information:
There is only one in vitro mutagenicity study concerning the mutagenic potential for n-Decyl methacrylate available where n-Decyl methacrylate was negative in vitro (Ames test, Zeiger et al., (1987)). The results of genetic toxicity studies of the structurally closely related Isodecyl methacrylate (i-C10-Ester) and Dodecyl methacrylate (C12-Ester) are considered to be representative for the genetic toxicity of n-Decyl methacrylate
(n-C10 -Ester).
The absence of a mutagenic potential was demonstrated for gene mutations as well as chromosome aberrations for the structurally closely related
Isodecyl methacrylate and Dodecyl methacrylate. So we expect n-Decyl methacrylate to be none mutagenic as well. This is also supported by the in vitro Ames test with n-Decyl methacrylate.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to the criteria as of directive 1272/2008/EC, no classification is warranted.
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