Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

An evaluation of the inherent properties of DTDA (CAS 101012-97-9) is performed against Annex XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment R.11: PBT Assessment (2012) were applied.

The available evidence on degradation is not sufficient for an assessment based on the Annex XIII criteria for Persistence (P and vP). As the substance is concluded to be not readily biodegradable as well as to be hydrolytically stables, it should be considered potentially P/vP from a precautionary point of view until further data become available.

Based on the log Kow of the representative uncharged molecules of DTDA (C13, C23, C26, C29), 5.2 to 12.9, a potential for bioaccumulation is indicated. C26 and C29 have log Kow values of > 10; therefore, the aquatic BCF is expected to be < 2000 L/kg. The log Kow estimates of these two molecules may be less accurate as both substances are not within the estimation domain of the used model. A log Kow of 7.67 (pH 7.0) was estimated for the charged di-iso-tridecylamine (C26, CAS 57157-80-9; representative molecule of DTDA, ca. 80%), indicating a potential for bioaccumulation. It should be noted that at log Kow values >6 a decreasing relationship to bioaccumulation is observed.

In addition, several (Q)SAR models predict BCF values < 2000 and further indicate a low potential for bioaccumulation due to metabolism and other mitigating factors (reduced BCF to < 2000).

The estimations are supported by experimental results following OECD 305 which were determined for n-hexadecylamine (CAS 143-27-1). The BCF was determined to be ≥ 500 (ECHA - RAC, 2011). Read across to this substance was accepted by the competent authorities within the PBT assessment of the analogous substance tridecylamine, branched and linear (CAS 86089-17-0).

In addition, a toxicokinetic study with mice using the analogous substance tridecylamine, branched and linear (CAS 86089-17-0), feedstock of DTDA, showed that metabolism was effective in detoxification and excretion. Therefore, it can be concluded that DTDA does not fulfil the B/vB criterion.

Regarding “T”, experimental chronic toxicity data are available for algae only. The lowest chronic value is greater than 0.01 mg/L. The screening criteria for T based on acute toxicity data are also not fulfilled. The substance does not hold any relevant official classifications. Thus, the T criterion is not fulfilled.

It can be concluded that the substance is assessed to be neither PBT nor vPvB.

Likely routes of exposure:

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