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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:

A substance that fulfils all three of the criteria for persistence, bioaccumulation and toxicity is a PBT substance according to REACH Regulation (EC) No 1907/2006. The substance, Vinasses, residue of fermentation, is considered not to be PBT or vPvB on the basis of the relevant data provided.

Persistence (P) Assessment:

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis and/or biodegradation). The substance, Vinasses, residue of fermentation, is readily biodegradable and therefore based on initial persistence screening is not expected to meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) Assessment:

The test substance Vinasses, residue of fermentation and all other members of the category are readily biodegradable. Therefore, it can be assumed that long term exposure to Vinasses in the aquatic or terrestrial environment is excluded. Further, the ready biodegradation implies good metabolization in microorganisms, and presumably vertebrates as well, which is underlined by the toxicokinetic assessment for the category members. Furthermore, due to the lack of any toxicological or ecotoxicological effects, it can be safely assumed that a potential bioaccumulation is unlikely to pose a risk for aquatic or terrestrial organisms. Therefore, based on the screening criteria for bioaccumulation stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Chapter R11: PBT/vPvB Assessment (2014), Vinasses, residue of fermentation is considered unlikely to be bioaccumulative.

Toxicity (T) Assessment

Environmental Toxicity:The substance was identified as not to be P and not to be B, therefore a toxicity assessment is not needed to demonstrate that the substance is not PBT. However, as demonstrated in section 6 of this report, none of the measured data for Vinasses, residue of fermentation is within the criteria for toxicity stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Chapter 11: PBT/vPvB Assessment (2014). No toxicity was observed in acute tests and the NOECs are > 10 mg/L in the available chronic tests. Therefore this substance is not considered toxic (T) for the environment.

Human Health Hazard: The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, the substance does not meet the “T” criterion for the human health.