Amides, C12-18, N-[3-(dimethylamino)propyl]

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.3 µg/L

Assessment factor:

50

PNEC freshwater (intermittent releases):

0.86 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.03 µg/L

Assessment factor:

500

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

0.2 mg/L

Assessment factor:

10

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

1.981 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.198 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

9.1 mg/kg soil dw

Assessment factor:

100

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

All endpoints are based on measured data applying assessment factors.

The PNEC_{aquatic bulk}is calculated using the assessment factor proposed by the TGD. As long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used. Based on the observed comparable or lower toxicity to fish it is considered unlikely that fish toxicity will be critical. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile other than for obtaining a lower assessment factor. It is therefore concluded that for scientific reasons and in accordance to REACH legislation further testing on fish has to be avoided for reasons of animal welfare. This means that it is proposed to waive the long term fish unless a further refinement of the effect assessment is considered necessary based on the outcome of the chemical safety assessment.

Conclusion on classification

Ecotoxicity

Due to intrinsic properties of amine containing cationic surfactants river water ecotoxicity tests deliver more reproducible test results with limited uncertainty. As river water has a mitigating effect on ecotoxicity due to sorption of the amines to suspended matter a factor of 10 should be applied to the effect levels to correct for the lower ecotoxicity observed.

 

Table Available algae, daphnia and fish test results (Klimisch 1, 2 and 4)

Algae		Fish	Daphnia
72 h EC50 (mg/L)	72 h EC10 (mg/L)	96 h LC50  (mg/L)	21 d EC50 (mg/L)	21 d EC10 (mg/L)	EC50corr (mg/L) **	EC10corr (mg/L) **)
0.085*	0.015*	0.58	0.5*	0.28*	0.0085	0.0015

 

  

 * The fish test is performed in reconstitued lab water. After correction for the mitigation possibly caused by the use of river water, the lowest L(E)C50 is the algae EC50

**corrected for Classification with Factor 10

 

Biodegradability

The substance is readily biodegradable

 Bioaccumulation potential

No measured BCF fish is available. Standard OECD 305 tests are technically very complicated with these strongly sorbing easily biodegradable substances. Based on a calculated log pow of 3.4 a low bioaccumulation potential is indicated for narcotic substances. For polar narcotics there is only limited information on the relationship between log Kow and BCF.

For hexadecyl amine rapid metabilisation in fish is anticipated based on in vitro metabolism test results with this substance (K_met= 0.152 1/d; Bernard et al., 2006). Based on the structural similarity and ready biodegradability of N-[3-(dimethylamino)propyl]-C12-18(even numbered)-alkylamide similar metabolisation rates are expected for this substance. According to the REACH PBT guidance R.11, evidence of high biotransformation/metabolisation rate in fish may be used to support for arguing for a limited bioaccumulation potential but quantitative thresholds have not been established. The use of QSAR- and mechanistically-based bioaccumulation models is also considered valuable in the overall bioaccumulation assessment process. The BCFBAF model (v3.0) as included in EPIsuite (v4.0) is used to calculate a BCF. With a log Kow of 3.4 the BCF model predicts a log BCF of 1.46.

 

Classification according(Classification, Labeling & Packaging Directive 1272/2008/EC)

As all acute ecotoxicity values (corrected and uncorrected) as given in the first table are below 1 mg/L the substances should be classified as acute aquatic hazard category 1. The substance is ‘readily biodegradable’ and have a log Kow < 4. Based on long-term studies a classification for chronic aquatic toxicity is warranted according to 2nd ATP to CLP. This leads to the following environmental classification

Acute (short-term) aquatic hazard category 1

M factor acute 100

Chronic aquatic hazard category 1

M factor chronic 1