Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

The assessment of Diethylaminoethylchloride hydrochloride (DEC) shows that the substance does not meet all the criteria for classification as PTB.  The substance has a low Log Kow estimated at:  Log Kow -1.00.  This low Log Kow is an indication that the substance is very hydrophilic and not B or vB.  In addition the bioaccumulation factor (predicted from valid EPI suit) is extremely low at 3.162 L/kg.  This is well below the > 2000 L/kg threshold which again indicated not B or vB. With respect to the persistency the predicted (EPI suit) Biowin 3 degradation rate is 2.6457 (weeks – months) and is below the > months threshold for persistent substances, therefore DEC is not P or vP.

With respect to the toxicity there is currently no evidence that DEC should be classified as (cat 1A or 1B), cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) in accordance with EC No. 1272/2008.  However there is evidence the DEC may be potentially mutagenic.  DEC has an oral toxicity LD50 of 25 to 200 mg/kg and has been found to give positive AMES test indicating the potential of mutagenic effects.  Based on this evidence DEC has the potential to be classed as T.

Likely routes of exposure:

The substance is not classified as PBT therefore there route of exposure is not relevant.