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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:

8.1.1. Persistence Assessment

The determination of the ready biodegradability of the test substance indicated that 100% degradation of the test substance occurred by day 20 based on BOD. The test substance is classified as readily biodegradable under the conditions of this test. Thus, based on the ECHA Guidance Documention (Chapter R.11, Section R.11.1.2.2 and Table R-11), the test substance would not be classified as either P or vP.

8.1.2. Bioaccumulation Assessment

A measured bioconcentration factor (BCF) for the test substance is not available. A calculated Log Kow value of 0.673 indicates a low potential for bioaccumulation. Thus, based on the ECHA Guidance Documention (Chapter R.11, Section R.11.1.2.2 and Table R-11), the test substance would not be classified as either B or vB.

8.1.3. Toxicity Assessment

Reliable acute aquatic toxicity test data are available for the test substanceforthe three principal trophic levels: primary producers, represented by algae; plant eating animals, represented by daphnids; and predators, represented by fish. A chronic fish or daphnid study is not available. Acute toxicity LC50or EC50values were all in excess of 100 mg/L. The test substanceis not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3).

There is no evidence to suggest classification of the test substance for chronic toxicity either as T/R48 or Xn/R48.

Due to the lack of long-term toxicity information in either a freshwater or marine organism, it is not possible to definitively assess the toxicity (T) criterion. However, based on acute aquatic toxicity values in excess of 100 mg/L, it is unlikely that the test substance would fulfill the toxicity criterion (T).

8.1.4. Summary and overall Conclusions on PBT or vPvB Properties

The ready biodegradability of the test substance in a screening level test indicates that it will not be persistent in the environment and that it is unlikely that its half-life in fresh water will exceed 40 days. Based on these results, the test substance would not be rated as either a P or vP substance.

Based on a calculated Log Kow values of 0.673, the test substance should not be rated as either a B or vB substance.

It is unlikely that the test substance would fulfill the toxicity criterion (T) as specified in the REACH regulation (Annex XIII), based on acute aquatic toxicity values in excess of 100 mg/L. Itis not classified as a carcinogen, mutagen, or as a reproductive hazard; also, there is no evidence of chronic toxicity of the test substanceas identified by classifications of T/R48 or Xn/R48.