Registration Dossier
Registration Dossier
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EC number: 695-101-5 | CAS number: 1275611-65-8
Endpoint summary
Administrative data
Description of key information
PNECsoil = 2.5 mg/kg dw based on one long term earthworm study.
The EPM based PNECsoil is 0.53 mg/kg dw based on an aquatic PNECbulk of 0.32 µg/L and a Kp soil of 1763 L/kg.
Additional information
No short term terrestrial test data is available for N-C16-18-alkyl-(even numbered, C18 unsaturated) trimethylpropane-1,3 -diamine. There is one long term terrestrial toxicity test available for N-C16-18-alkyl-(even numbered, C18 unsaturated) trimethylpropane-1,3-diamine. The long earthworm test resulted in a NOEC of 250 mg/kg dw for reproduction using artificial soil with only 5% finely grounded peat. The reliability of the long term earthworm test is considered higher than the results of the EPM. The observed NOEC of 250 mg/kg dw is therefore used for the derivation of the PNECsoil.
With an assessment factor of 100 a PNECsoil is calculated of 2.5 mg/kg dw
For comparison reasons the PNECsoil was also calculated using the equilibrium partitioning method as presented below.
The EPM based terrestrial PNEC (without the correction for additional uptake via food) of 0.53 mg/kg dw ....... to the PNEC as based on the long term earthworm study of 2.5 mg/kg dw.
Distribution constants for for N-C16-18-alkyl-(even numbered, C18 unsaturated) trimethylpropane-1,3 -diamine as used in the calculation of the PNECsoil.
Kpsoil |
1763 L/kg |
Ksoil-water |
2646 m3/m3 |
Kpsusp |
3526 L/kg |
Ksusp-water |
882 m3/m3 |
Kpsed |
1763 L/kg |
Ksed-water |
882 m3/m3 |
Since PNECfreshwater is based on the bulk concentration, a recalculation was necessary to PNECfreshwaterdissolved before application of the equilibrium partitioning method. The following equation was used:
PNECfreshwaterdissolved= PNECfreshwaterbulk/ (1 + Kpsusp*SUSPwater*10 -6)
Where:
PNECfreshwaterbulk= 0.32 µg/L
Kpsusp= 3526 L/kg
SUSPwater= 15 mg/L.
The resulting PNECfreshwaterdissolved= 0.304 µg/L.
The PNECsoil is then calculated using the equations detailed in REACH guidance R.16:
PNECsoil = Ksoil-water* PNECaquatic dissolved* 1000 * 1 / RHOsoil
Where: PNECaquatic = 0.304 µg/L
Ksoil-water = 2646 m3/m3
RHOsoil = 1700 kg/m3(TGD, equ. 18)
PNECsoil-EPM = 0.473 mg/kg ww
= 0.53 mg/kg dw
*More than 95% of the currently available ecotoxicity data on sediment and soil organisms for cationic surfactants show that the additional safety factor for exposure via ingestion is over conservative when these data are compared to the EPM based toxicity. It should be noted that real measured sorption data are used which are not normalized to the organic matter content of the soils and that for both sediment and soil the same Kd is used. For suspended matter however the Kd is doubled to compensate for the additional sorption due to a higher content of small particles.
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