Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

C4 sulfonamido methacrylate as registered consists of the substance itself as well as three impurities. These impurities comprise ≤4% of the total composition. A limited amount of data suitable for the PBT assessment are available for C4 sulfonamido methacrylate, with the remainder being derived by read across from C4 acrylate. A comprehensive justification of read across is provided in IUCLID section 13. Both C4 sulfonamido methacrylate and C4 acrylate were extensively metabolized in vivo during toxicokinetic studies. When tested in parallel toxicology studies, C4 sulfonamido methacrylate show the same or lower toxicity as C4 methacrylate. C4 sulfonamido methacrylate and C4 acrylate are not PBT or vP/vB compounds.

No data are available for the three impurities, 2-Propenoic acid, 2-methyl-, 2-[methyl[(1,1,2,2,3,3,4,4-octafluorobutyl)sulfonyl]amino]ethyl ester, 2-Propenoic acid, 2-methyl-, 2-[2-[methyl[(1,1,2,2,3,3,4,4,4-nonafluorobutyl)sulfonyl]amino]ethoxy]ethyl ester, and 2-(2-{methyl[(1,1,2,2,3,3,4,4-octafluorobutyl)sulfonyl]amino}ethoxy)ethyl 2-methylprop-2-enoate. These impurities are based on two structural differences to C4 sulfonamido methacrylate: a terminal hydrogen substitution resulting in an octafluorobutyl side chain, and an ethylene oxide duplication between the sulfonamide nitrogen and the methacrylate group. Neither change is expected to cause substantial changes to reactivity or lipophilicity, such that the impurities have similar persistance, bioaccumulation potential, or toxicity to C4 sulfonamido methacrylate and C4 acrylate. Data for these latter two compounds are read across to the impurities to perform the assessment. By read across, the impurities are also not considered PBT or vPvB.

By readacross, the constituent of this substance AND the main impurities do NOT meet the specific criteria in Annex XIII Section 1, or while not allowing a direct comparison with all the criteria, nevertheless indicate that each substance would not have these properties. Substance is NOT PBT or vPvB.