Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Methyl acrylate showed no evidence of carcinogenicity in a 2-year vapour inhalation study in Sprague-Dawley rats up to the highest tested dose (135 ppm = 0.519 mg/L).

Key value for chemical safety assessment

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.3, 2009): no classification required

Additional information

Sprague-Dawley rats (86/sex/group) were exposed to methyl acrylate vapour at 15, 45, or 135 ppm (0.058, 0.173, 0.519 mg/L/), 6 hrs/day, 5 days/week for 2 years. During the initial 13-week period, the concentrations were 5, 15 and 45 ppm (0.019, 0.058, 0.173 mg/L). One group of 86 rats/sex was exposed to air and served as control. Interim kills were performed after 12 and 18 months of exposure (BASF AG 1985, Reininghaus et al. 1991). A temporary retardation of body weight gain was observed in the high-dose group. Dose-related degeneration of the olfactory epithelium (primarily the anterior portion) and a subsequent regeneration and replacement with respiratory epithelium was also observed at the highest dose. No differences in the incidences of preneoplastic or neoplastic lesions were observed between control and exposed groups. (see also Section 7.5 Repeated Dose Toxicity)

Conclusion

Methyl acrylate was not carcinogenic in an adequately performed 2-year inhalation study in Sprague-Dawley rats up to the highest tested dose (135 ppm = 0.519 mg/L).