Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Persistence Assessment

The substance is not readily biodegradable following the criteria given by OECD Guidelines for the Testing of Chemicals (30 % after 28d) but an aerobic soil environment will have a significant contribution to the overall degradation of the substance. The half-lives in aerobic soils (DT50) of the substance were between 2.3 to 10.6 days at 20°C in the different soils. Under anaerobic conditions, cyprosulfamide degraded slower with a half-life of approx. 48.5 – 59.5 days at 20°C. Therefore the substance will be not persistent in the environment.

The substance does not meet the P criterion.

Bioaccumulation Assessment

Test data on bioaccumulation are not available as this endpoint. However, the log Kow of the test substance was measured to be > 3 (log Kow of 1.77 at 23 °C at pH 4, log Pow of -0.80 at 23 °C at pH 7 and a log Pow of -1.81 at 23 °C at pH 9), which is below the trigger value of 4.5, and no specific uptake mechanism is known or suspected. Thus, the substance can be considered as not B and not vB and further evaluation of the B and vB criteria is not necessary according to the “Guidance on information requirements and chemical safety assessment, Part C PBT Assessment” (ECHA, 2008).

Therefore, the substance does not meet the B criterion.

Toxicity Assessment

From the ecotoxicity perspective the toxicity criterion is not met for the test substance, because all LC50/EC50 were > 100 mg/L, measured), which was clearly above the NOEC trigger value of < 0.01 mg/L, stated as screening criteria for toxicity in the “Guidance on information requirements and chemical safety assessment, Part C PBT Assessment” (ECHA, 2008).The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC and does not meet the T criterion from the toxicology perspective.

The substance does not meet the

T criterion.

Summary and overall Conclusions on PBT or vPvB Properties

The test substance does not fulfil the PBT and vPvB criteria.