Registration Dossier

Diss Factsheets

PBT status:
the substance is not PBT / vPvB

The substance has demonstrated that it meets the ‘ready biodegradability’ criteria at the screening level (OECD TG 301B), with ca. 77% biodegradation, based on Carbon dioxide (CO2) evolution achieved after 28 days, respectively. The 10-day window was not applicable to the substance consisting of structurally similar constituents (relevant isomers) (OECD, 2006). The substance has demonstrated an n-octanol/water partition coefficient of log Kow < 4.0 via a reliable HPLC screening study (OECD TG 117) and with supporting QSAR predictions indicating comparable results. The log Pow range is ≥ -2.0 to ≤ 2.8 within the range of pH 4, pH 7 and pH 9. Therefore, the conclusion for the substance is that it is not bioaccumulative (i.e. BCF < 500 and/or BCF << 2000) in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11 as it does not fulfil the screening criteria for bioaccumulation potential. While a full dataset on chronic aquatic toxicity data is not available, the substance is not considered toxic based on consideration of the available chronic and acute aquatic toxicity study data in algae, daphnia and fish (per OECD TG 201, 202, 203), by read-across to structural analogue and/or using bridging data on the present substance (Daphnia Sp. toxicity, OECD TG 202) which do not fulfil the screening criteria for toxicity based on the long term EC10 or NOEC or short term EC50 values of these studies. Based on the available information, the substance is not classified as having CMR properties, nor does it show other evidence of toxicity criteria based on read-across to structural analogue available sub-acute or screening studies for systemic or reproductive/developmental toxicity studies in animals. It is noted that further information is required in mutagenicity.Intent to read-across to source substance OECD TG 489, COMET Assay (in vivo mammalian cell study: DNA damage and/or repair) currently under test proposal assessment. Source substance: Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide ; EC/List Number: 810-703-1 / CAS Number: 1187441-10-6. At the present time the substance is not classified for mutagenicity (‘inconclusive’ pending the outcome of further information). In conclusion, the substance is not PBT and not vPvB.

Likely routes of exposure:

Not applicable. Substance is not PBT/vPvB.