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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

1-Isopropyl-2,2-dimethyltrimethylene diisobutyrate consistently failed to attain 60% degradation (CO2 evolution) within a 10-day window in screening-level tests for ready biodegradability. Although reaching acceptable levels of degradation suggesting it is inherently and ultimately biodegradable, it was not rated as readily biodegradable. However, based upon the guidance provided in section R.7.9.5.2 (Guidance Document, Chapter R.7b) the 10 day window criterion is not necessary for defining the pass level for evaluation of the P criterion. Therfore the > 70% degradation in 28 days exhibited by TXIB indicates that the substance would not be considered to be persistent (P) or vP under the REACH regulation (Annex XIII). The lipid-corrected BCF value for 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate in bluegill sunfish is 2.69. Based on this value, 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate is not rated as either B or vB under the REACH regulation (Annex XIII). 1-Isopropyl-2,2-dimethyltrimethylene diisobutyrate fails to meet the toxicity criterion (T) as specified in the REACH regulation (Annex XIII): the chronic toxicity NOEC values in freshwater organisms are in excess of 0.01 mg/L; 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate is not classified as a carcinogen, mutagen, or as a reproductive hazard; also, there is no evidence of chronic toxicity for 1-isopropyl-2,2-dimethyltrimethylene diisobutyrate as identified by classifications of T/R48 or Xn/R48. 1-Isopropyl-2,2-dimethyltrimethylene diisobutyrate is not a PBT or vPvB substance by the criteria specified in the REACH regulation (Annex XIII).