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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:

An evaluation of the inherent properties of Tridecylamine, branched and linear(CAS 86089-17-0) 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.

Tridecylamine, branched and linear, has been deleted from the list of potential PBT/vPvB substances since the substance does not fulfil the PBT and vPvB criteria (ESIS, 2008). Based on experimental data from an OECD 305 study with the analogue substance n-hexadecylamine, the BCF was concluded by the ECHA - Risk Assessment Committee to be in the region of 500 L/kg or above (RAC; 2011). This BCF value is based on the minimum measured exposure concentrations (50% of nominal = 1.5 µg/L) and the whole fish concentration after removal of the physically absorbed test item (mucous and scales).In addition, considering molecular size and other mitigating factors, at least all reliable models predict BCF values of clearly below 2000, indicating that the substance does not fulfill the "B"-criterion and therefore also not the “vB”-criterion.

The low potential of bioaccumulation of tridecylamine, branched and linear, is supported by a toxicokinetic study with mice performed by Fowler et al. (1976; see IUCLID Ch. 7.1.1). After injection of radiolabeled tridecylamine into mice, its fate in mice was followed. It was shown that the mice tended to concentrate the substance in lung tissue. The authors could also show that tridecylamine was metabolised (excretion of carbon dioxide). It was concluded that tridecylamine, like other monoalkylamines, undergoes oxidative deamination by monoamine oxidase and is further metabolised to carbon dioxide.

BCF values were also calculated for the structurally similar C13 amine 1-Tridecanamine (CAS 2869-34-3) using several QSAR models (IUCLID Ch. 5.3.1). The results indicate a low bioaccumulation potential for TDA, b+l. Considering mitigating factors like metabolism the reliable models predict BCF values of clearly below 2000, indicating that the substance does not fulfil the "B"-criterion:

- CATALOGIC v.5.11.15 BCF base-line model v02.08: BCF = 1072 to 1097 (within AD)

 - EPI Suite v4.11 - BCFBAFv3.01: Meylan et al. (1997/1999): BCF = 58 (within AD); Arnot & Gobas (2003): BCF = 1280 (within AD; however, result less accurate as substance ionisies appreciably)

 - VEGA tool v1.1.1: CAESAR v2.1.14: BCF = 721 (not within AD); Meylan v1.0.3: BCF = 58 (not within AD); KNN/Read-Across v1.1.0: BCF = 27 (not within AD)

 - US EPA T.E.S.T. v4.1: Consensus method: 82.81 (within AD; low confidence)

Regarding "T", chronic data are available for algae only, which was the most sensitive organism in acute toxicity studies. The 72-h ErC10 was determined to be 0.003 mg/L and hence is below the critical value of 0.01 mg/L for chronic aquatic studies. Therefore the substance is assessed to be T.

Toxicity data are also available for the terrestrial compartment. Long-term effects on earthworms were investigated in a GLP guideline study following OECD TG 222 with Eisenia fetida (BASF SE, 2016; report no. 68E0391/03G010). The 28-d LC50 is greater than 1000 mg/kg soil dw. The effect on the reproduction after 56 days was: EC10 = 437 mg/kg soil dw.

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.