Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, dioleates

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

6.38 µg/L

Assessment factor:

50

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

5.09 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.638 µg/L

Assessment factor:

500

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

98.6 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

204 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

20.4 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:

9.93 mg/kg soil dw

Assessment factor:

100

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Ecotoxicity testing with cationic surfactants is complicated as these substances tend to sorb to negatively charged surfaces like glassware organic and suspended matter. The reproducibility of these tests is in general poor. When cationic surfactants enter the environment they will be immediately sorbed to the suspended matter and DOC present in the environment. The toxicity will due to this sorption be mitigated. The degree of this mitigation is however poorly predicted with the currently available exposure models (e. g. EUSES) as they only predict sorption based on hydrophobic interaction with organic matter where the main sorption of these substances will be due to ionic interaction. To increase the reproducibility of the ecotoxicity testing and to compensate for the deficiency of the bioavailability modeling tests have been performed with river water. To ensure the representativeness of the test results, realistic worst-case river water (DOC close to 3 mg/L and suspended matter close to 15 mg/L) has been used. These river water studies should therefore be considered as higher tier studies. This approach is also applied in EU risk assessments of DODMAC and primary fatty amines and is known as the Bulk-approach (ECETOC TR88 2003).

In order to classify a standard laboratory toxicity study as valid, it is of particular importance that - besides information on test substance, test method/conditions and test organism used - suitable precautions are taken to prevent the loss of test substance by adsorption and that exposure concentrations are based upon measured levels.

For ecotoxicity tests performed using the bulk-approach, however, adsorption to suspended matter and DOC is acceptable and only adsorption to glassware should be accounted for. For a valid bulk approach test the concentration-effect relationship should be based on the sum of adsorbed and dissolved substance in the volume of the medium tested. One of the advantages of the bulk approach tests with these difficult substances is that in the presence of suspended matter, humic acids and/or algae, the residual sorption to glassware will be negligible. The observed sorption to glassware was 2% in the algae test at a test concentration of 316 µg/L and 4% in the long-term daphnia test at a test concentration of 1 mg/L at the end of both tests. The results of these bulk approach tests are therefore much easier to interpret, more environmental realistic, and when compared to PECbulk clearly provide a more appropriate assessment of risks for the environment. All effect values given are therefore based on the nominal test item concentrations.

PNECs are based on the following data for the test substance (or read-across to N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate] if marked with "*"):

Test type	Results
Microorganisms, activated sludge	3h-NOEC respiration: 986 mg/L
Short-term studies
Daphnia magna	21d-EC50: 1.40 mg/L*
Danio rerio	96h-LC50: 1.34 mg/L*
Pseudokirchneriella subcapitata	72h-ErC50: 0.502 mg/L
Chronic studies
Pseudokirchneriella subcapitata	72h-ErC10: 0.319 mg/L
Daphnia magna	No long-term effects were observed during the chronic daphnia test.
Terrestrial studies
Eisenia fetida	56d-NOEC reproduction, biomass, mortality: 993.2 mg/kg soil dw*

 

The PNEC freshwater has been derived on the basis of aquatic toxicity data determined in tests employing river water. The river water data are based on nominal concentrations. The rationale behind the use of river water tests is the strong sorption to organic matter and test vessels of the substance. The derived PNECbulk will be compared to the PECbulk (which includes the fraction adsorped onto suspended matter) in the risk characterisation. The same approach has been used for other cationic and anionic surfactants.

 

The PNECaquatic bulk is calculated using the assessment factor proposed by the REACH guidance. As long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used. With the same motivation, AF of 500 has been used for the derivation of PNEC marine.

No tests were performed with sediment organisms. The PNECs for sediment is derived using the equilibrium partitioning theory and Koc. All relevant substance characteristics were entered into EUSES version 2.1.2 to produce PNECsediment for the freshwater and marine compartment as well as PNECsoil. Since PNECfreshwater is based on the bulk concentration present in surface water, a recalculation was necessary to PNECfreshwater, dissolved before application of the equilibrium partitioning method. The following equation was used:

PNECfreshwater, dissolved = PNECfreshwater, bulk/ (1+ Kpsusp*SUSPwater*10-6)

where PNECfreshwater,bulk = 6.38 µg/L, Kpsusp = 60136 L/kg (EUSES), and SUSPwater = 15 mg/L. The resulting PNECfreshwater, dissolved = 3.4 µg/L. PNECfreshwater,sediment, PNECmarine, sediment and also PNECsoil were then calculated directly with EUSES employing PNECfreshwater, dissolved of 3.4 µg/L. As the log Kow value of 32.91 for this substance is outside the applicability domain of EUSES, measured Kd and Koc values were entered in EUSES.

For the terrestrial compartment, one long term study is available showing that the 56-d NOEC of the substance was ≥ 993.2 mg/kg dw. According to the guidance, when only one test result with soil dwelling organisms is available the risk assessment is performed both on the basis of this result using assessment factors and on the basis of the equilibrium partition method (EPM, see above; Kp,soil = 30068). From both PECsoil/PNECsoil ratios the highest one is chosen for the risk characterisation. Therefore, the PNEC was calculated both based on the long term study as well as the EPM.

The PNEC soil based on EC10 from earth worm reproduction test (OECD 222, reliability 1) and an assessment factor of 100. This would result in a PNEC of 9.93 mg/kg dw. PNEC soil based on the EPM is derived from PNEC freshwater, dissolved (3.4 ug/L) using the equilibrium partitioning method and the experimentally determined Kp soil of 30068 L/kg resulting in a PNEC soil of 101 mg/kg dw. As the PECsoil is independent of the calculation method, the PNEC soil derived from the long term study will result in the highest PECsoil/PNECsoil ratios and is therefore chosen for the risk characterization: the PNECsoil is 9.93 mg/kg dw.

Conclusion on classification

For classification purposes Ecotoxicity, Biodegradability and Bioconcentration have to be considered.

Ecotoxicity

Due to intrinsic properties of the test substance, river water ecotoxicity tests deliver reproducible test results with limited uncertainty. As river water has a mitigating effect on ecotoxicity due to sorption of the quaternairy ammonium ethoxylates to DOC and suspended matter, a factor of 10 should be applied to the L(E)Cx and NOEC to correct for the lower ecotoxicity observed. Algae are in general the most sensitive species and are therefore the basis for classification of Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate]. It should be noted that the 21day-daphnia EC50 is included in the table below for classification purposes as a worst-case for acute toxicity in river water tests.

 

The classification is based on the following aquatic toxicity data for the test substance (or read-across to N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate] if marked with "*"): 

Test type	Results	Correction for river water with factor 10
Short-term studies
Danio rerio	96h-LC50: 1.34 mg/L*	134 µg/L
Daphnia magna	21d-EC50 adult mortality: 1.40 mg/L*	140 µg/L
Pseudokirchneriella subcapitata	72h-ErC50: 502 ug/L	50.2 µg/L
Chronic studies
Daphnia magna	No long-term effects were observed during the chronic daphnia test.	No long-term effects were observed during the chronic daphnia test.
Pseudokirchneriella subcapitata	72h-ErC10: 319 µg/L	31.9 µg/L

 

Biodegradability

The substance is rapidly biodegradable in the environment as demonstrated with a Closed bottle test according to OECD TG 301 D. The biodegradation percentage was > 60% after 28 days.

 

Conclusion classification according to CLP Regulation 1272/2008

Based on the results of the acute aquatic toxicity (values < 1 mg/L) the substance is classified with Category Acute 1 (M-factor 10).

Reliable chronic toxicity data are available for crustacea and algae with chronic EC10 resp 1.35 mg/L and 0.319 mg/L. In addition the substance is readily biodegradable. Based on the lowest results of the chronic aquatic toxicity (0.01 < corrected ErC10 < 0.1 mg/L) and since the substance is rapidly biodegradable, the substance is classified with Category Chronic 2. 

 

Classification according to 67/548/EEC (DSD)

Acute aquatic toxicity is < 1 mg/L and the substance is rapidly biodegradable and has a high bioaccumulation potential (log Kow of 32.91). Therefore the substance is classified with N:R50/53.