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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:

L-isoleucine was determined to be readily biodegradable based on read-across from a recent GLP and OECD guideline study on L-valine (> 80% biodegradation within 28 d), in combination with an older determination of the biodegradation potential of L-isoleucine according to the Offhaus method.

Bioaccumulation of L-isoleucine can be excluded based on its low log Kow of -1.72.

L-isoleucine is not classified as carcinogenic, mutagenic, toxic for reproduction or Specific Target Organ Toxicity after repeated exposure according to Regulation EC No. 1272/2008 (CLP). L-isoleucine was determined not to be aquatic toxic based on read-across to L-valine (short-term toxicity test for fish and aquatic invertebrates) up to concentrations of 1000 mg/L.