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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:

The substance does not fulfil the criteria for PBT .

Persistence: According to REACH Annex XIII, resp. the more detailed "Information requirements Part C" (2012) the persistency screening criteria regarding Biowin calculation are not fullfilled for Formamidopropylbetain. The substance is not regarded as persistent.

The substance was not readily biodegradable under the conditions of the modified Sturm test performed. The test substance demonstrated potential for inherent biodegradation with biodegradation values of 31 % and 39 %.

(see section 5.2).

Bioaccumulation: The substance has a low potential for bioaccumulation according to the measured logKow = - 3.3. (see section 4.7).

Toxicity: it is not toxic with NOEC < 0.01 mg/l for all trophic levels (see section 6.1), does not need to be classified for carcinogenic, mutagenic or reproductive toxicity, and shows no evidence of chronic toxicity identified by classification according to Direcitve 67/548/ EEC or Regulation EC No. 1272/2008.