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Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

8.1. Assessment of PBT/vPvB Properties - Comparison with the Criteria of Annex XIII

 

8.1.1. Persistence Assessment

Due to the results from chapter 4.1 Degradation showing the substance to be readily biodegradable, the substance is not considered to be persistent (not P) and not very persistent (not vP) in the environment.

8.1.2. Bioaccumulation Assessment

Due to the results from chapter 4.3 Bioaccumulation the substance is not bioaccumulative (not B) and not very bioaccumulative (not vB) based upon a low log Kow value (<3.0) and model predictions.

8.1.3. Toxicity Assessment

Due to the results of the aquatic toxicity studies (see chapter 7.1. Aquatic compartment including sediment), the

substance is not toxic (not T).

 

The relevant mammalian toxicity studies (see chapter 5. Human Health Hazard Assessment), show only low

toxicity for isobutyric acid in acute oral and dermal studies.

 

No toxicity for long-term endpoints results from the respective studies, so according to Annex XIII, REACh the substance is not toxic.

8.1.4. Summary and overall Conclusions on PBT or vPvB Properties

Hydrolysis studies document that isobutyric anhydride rapidly and completely hydolyses to isobutyric acid in the environment and in biological systems. Isobutyric acid data indicates that none of the criteria for PBT or vPvB have been met, thererfore isobutyric anhydride is also not considered to be a PBT or vPvB substance.

8.2. Emission Characterisation

Because the substance does not fulfill the PBT and vPvB criteria, no emission characterization is performed.