Isodecyl methacrylate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

In an OECD 422 / GLP study, rats received the structurally closely related Dodecyl methacrylate at dose-levels of 100, 300 and 1000 mg/kg/d. Neither substance-induced effects on the male and female reproductive performance, nor on the offspring at any dose-level were observed.The NOAEL (reproduction/developmental) was considered to be 1000 mg/kg/d in males and females.

In addition, a two-generation reproduction toxicity GLP study in rats (OECD 416) with the structural analogue Methyl methacrylate was used for assessment. The dosages were up to 400 mg/kg/d. The mid- and high-dose parental animals showed clinical signs of systemic toxicity. The NOAEL for general, systemic toxicity was 50 mg/kg/d for the P and F1 parental rats, based on adverse effects on food consumption observed at the LOAEL of 150 mg/kg/d in the P parental females. The NOAEL for fertility and reproductive performance for the P and F1 parental rats was 400 mg/kg/d. The NOAEL for developmental toxicity in the F1 and F2 generation was 400 mg/kg/d as well.

In conclusion, based on studies with analogous methacrylate esters in experimental animals, there is no evidence for toxicity of Isodecyl methacrylate to the reproductive system. For the sake of animal welfare, it is not considered as justified to conduct further studies.

Short description of key information:
Results of the toxicity to reproduction studies on structurally closely related alkyl methacrylate esters are considered as representative for Isodecyl methacrylate.
In an OECD 422 GLP study with Dodecyl methacrylate, the NOAEL for reproductive toxicity is considered to be 1000 mg/kg/d for all relevant
endpoints. Methyl methacrylate has been tested in a two-generation reproduction toxicity study in rats (OECD 416). The NOAEL for general, systemic toxicity was 50 mg/kg/d (due to adverse effects on food consumption) and the NOAEL for fertility and reproductive performance was 400 mg/kg/d. In
conclusion, based on the existing studies with analogous methacrylate esters in experimental animals, there is no evidence for toxicity to the
reproductive system with respect to Isodecyl methacrylate. For the sake of animal welfare, it is not considered as justified to conduct further studies.

Effects on developmental toxicity

Description of key information

In an OECD 422 GLP study with the structurally closely related Dodecyl methacrylate in rats, the NOAEL for development of offspring was at 1000 mg/kg/d. Moreover, there is extensive information available where the absence of a teratogenic potential was demonstrated representatively for 
all alkyl methacrylate esters in teratogenicity studies in rats and rabbits (OECD 414) with Methyl methacrylate and n-Butyl methacrylate. 
In conclusion, based on studies with analogous methacrylate esters in experimental animals, there is no evidence for developmental toxicity and 
teratogenicity of Isodecyl methacrylate. For the sake of animal welfare, it is not considered as justified to conduct further studies.

Additional information

In an OECD Guideline 422 and GLP study with Dodecyl methacrylate in rats, the NOAEL for development of offspring was at the highest test dose of 1000 mg/kg/d. Moreover, there is extensive information available for further structurally analogous methacrylate esters. In an inhalation developmental toxicity study with Methyl methacrylate in rats (OECD 414), exposure to concentrations up to 8.3 mg/L (2028 ppm) resulted in no embryo or fetal toxicity or malformations even at exposure levels that resulted in maternal toxicity.  In a study with n-Butyl methacrylate comparable OECD 414, rats were exposed at target concentrations up to 1200 ppm. Maternal toxicity was observed at 300 to 1200 ppm. The NOAEL for developmental toxicity was 300 ppm. There was no evidence of embryolethality or teratogenicity. With Methyl methacrylate, an oral OECD 414 study in rabbits was performed with doses of 50, 150, and 450 mg/kg/d. The NOAEL for prenatal developmental toxicity was 450 mg/kg/d. No adverse foetal findings of toxicological relevance were evident at any dose, even in the presence of maternal toxicity.

In conclusion, based on studies with analogous alkyl methacrylate esters in experimental animals, there is no evidence for developmental toxicity and teratogenicity of Isodecyl methacrylate. For the sake of animal welfare, it is not considered as justified to conduct further studies.

Justification for classification or non-classification

According to the criteria as of directive 1272/2008/EC, no classification is warranted.