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:

Criteria for assessing PBT properties are defined in Annex XIII of the REACH Regulation (EC) No. 1907/2006. Further details are laid down in ECHA Guidance on Information Requirements and Chemical Safety Assessment; Chapter R.11: PBT Assessment (November 2012). The assessment of PBT / vPvB properties is based upon a separate assessment for each parameter (i.e. P or vP, B or vB and T). Substances are only assigned as PBT or vPvB when they fulfil the criteria for all three properties (persistency, bioaccumulation and toxicity in case of PBT substance) or both criteria (i.e. very persistent and very bioaccumulative) in case of vPvB, respectively.

Based on test results referring to ready and inherent biodegradation, Butyldiethanolamine is considered as potentially persistent (P) but not as very persistent (not vP). The B criterion (bioaccumulative substance) is not fulfilled, due to the experimentally determined logPow of 0.58 (BASF AG, 1993) and the experimentally determined Bioconcentration factor (steady state: < 39; NITE, 2011).

Due to the lack of a long-term toxicity potential, also the T criterion is not fulfilled. Furthermore, no classification exists as carcinogenic, mutagenic or toxic for reproduction according to Regulation (EC) No. 1272/2008. The test substance is neither classified as "T, R48" or as "Xn, R48" based on the criteria laid down in Directive 67/548/EEC nor as STOT RE category 1 or 2 so far.

In conclusion, Butyldiethanolamine is only considered as potentially "P". Thus, the substance is neither PBT nor vPvB.

Likely routes of exposure:

Neither direct nor indirect exposure of the solely substance Butyldiethanolamine to the environmental compartment is intended. Workers may be exposed via the dermal route due to substance handling during manufacture.