Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.84 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.827 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.084 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.3 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.19 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.32 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1.59 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs are based on the following data:

Test type

Results

 Remarks

Microorganisms, activated sludge

3h-EC10respiration: 13 mg/L

 GLP, reliability 1,

 (Klee, 2012)

Short-term studies

 

 

Daphnia magna

21d-EC50parental mortality: 1.05 mg/L

 GLP, Reliability 1,

 (Noack, 2012)

Danio rerio

96h-LC50: 2.14 mg/L

 GLP, Reliability 1,

 (Scheerbaum, 2012)

Pseudokirchneriella subcapitata

72h-ErC50: 0.0827 mg/L

GLP, Reliability 1,

 (Scheerbaum, 2012)

Chronic studies

 

 

Pseudokirchneriella subcapitata

72h-ErC10: 0.042 mg/L

 GLP, Reliability 1,

 (Scheerbaum, 2012)

Daphnia magna

21d-EC10repro: 0.738 mg/L

 GLP, Reliability 1,

 (Scheerbaum, 2012)

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 of the substance. The derived PNECbulk will be compared to the PECbulk (which includes the fraction adsorped onto suspended matter and DOC) 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. However based on the observed lower toxicity to fish in acute tests, it is considered unlikely that long term fish toxicity will be critical for the PNEC derivation. 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 and that based on the weight of evidence available on the ecotoxicity data it is considered justified to apply a safety factor of 10 for the derivation of the PNECaquatic, bulk. With the same motivation, AF of 100 could be used for the derivation of PNEC marine.

For precautionary reasons however the default AF of 50 is used for freshwater and 500 for the marine compartment.

No tests were performed with sediment organisms or terrestrial organisms. The PNECs for those compartments were derived using the equilibrium partitioning theory and Kd. Since PNECfreshwater is based on the bulk concentration, a recalculation was necessary to PNECfreshwater dissolved before application of the equilibrium partitioning method. The following equation was used:

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

Where:

PNECfreshwaterbulk = 4.21 µg/L

Kpsusp = 4020 L/kg

SUSPwater = 15 mg/L.

The resulting PNECfreshwater dissolved = 3.97 µg/L.

The PNEC for sediment is then calculated applying the EPM:

PNECsed = Ksusp-water* PNECaquatic dissolved

Where:

PNECaquatic dissolved = 3.97 µg/L

Kpsusp              = 4020 L/kg

PNECsed-EPM       = 16 mg/kg dw             

PNECsoil was calculated according to the same method using Ksoil-water = 2010 L/kg.                                  

Considering the use of the EPM for cationic surfactants:

The ECHA Guidance on information requirements and chemical safety assessment(v.4.0, June 2017), Chapter R7b states that “EPM is based on sorption to organic matter. Therefore, it cannot be used for some classes of substances, e.g. when binding behaviour is not driven by lipophilicity (e.g. aromatic amines forming covalent bonds to sediment components, ionisable substances, surface active substances).”

Thus, the use of the EPM needs to be sufficiently justified.

 

The use of the EPM is thus questioned for the derivation of the PNECsed and soil for cationic surfactants. The EPM equation is however not only used for the hazard assessment but also for the calculation of the dissolved concentration in the last steps of the exposure assessment. See Equations R.16-34 and R.10 -2

The EPM equation is thus used for the effects assessment but also for the exposure assessment and when applied on both the effect and exposure side in the same way the unknown error in the ratio in the equation cancels each other out when the RCR is calculated.              

In short the EPMcan be used for cationic surfactants to predict the hazards for the benthic compartment in case on both the effect and exposure side the EPM is used in an identical way.

To evaluate if the EPM can be used conservatively for cationic surfactants, results from long term daphnia and sediment tests for 8 different cationic surfactants were used See table below. The results of the sediment studies were compared to the EPM calculated sediment effects. For 5 out of the 8 the EPM predicted the EC10 for sediment organisms more conservatively than what was observed in the sediment test without applying the additional safety factor of 10 to compensate for ingestion. After including the additional AF (of 10), for all 8 substances the EPM was found to be more conservative than the observed sediment toxicity. The Kp sups-water for these substances ranged from 1040 L/kg to 20100 L/kg.

New data sediment and daphnia data on cationic surfactants will be added to the dataset in the end to generate sufficient support using the appropriate ECHA guideline to report the respective information.

 

Name CAS number Long term daphia NOEC/EC10 dissolved (µg/L) EPM data sediment Ratio observed/predicted NOEC/EC10 
Kpsusp-water* (L/kg) AF for ingestion Observed Benthic NOEC/EC10 (mg/kg dw) Predicted Benthic NOEC/EC10 using the EPM (µg/L)
Amines, N-C16-18-alkyl (evennumbered) propane-1,3-diamine 133779-11-0  315.08 1040 y 86 32.88 2.62
1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate 102047-27-8 87.37 4020 y 134 35.15 3.81
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides 68607-24-9 124.61 1813.5 y 62.5 22.64 2.76
2,2'-(octadec-9-enylimino)bisethanol 25307-17-9 9.62 7460 n 101.2 71.82 1.41
Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides 68391-05-9 8.55 16800 n 320 143.61 2.23
C16-18-(even numbered, C18-unsaturated)-alkylamines 68037-95-6 12.73 1394 n 188 17.80 10.56
Quaternary ammonium compounds, di-C10-alkyldimethyl, chlorides 7173-51-9 14.00 20098.8 n 530 281.43 1.88
C12-16 alkyldimethylbenzylammonium chloride 68424 -85-1 4.15 16778.8 n 520 278.53 1.87

*It should be noted that for all substances 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.

Conclusion on classification

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

Ecotoxicity

Due to intrinsic properties of etheramine/etheramine acetate, 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 etheramine/etheramine acetate to DOC and suspended matter, a factor of 10 is 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 the etheramine/etheramine acetate. 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:

 

Test type

Results

Test substance

Correction for river water with factor 10

Short term studies

Danio rerio

96h-LC50: 2.14 mg/L

Etheramine acetate

 214 μg/L

Daphnia magna

21d-EC50parent immobility: 1.05 mg/L

Etheramine acetate

 105 µg/L

Pseudokirchneriella subcapitata

72h-ErC50: 0.0827 mg/L

Etheramine

 8.3 µg/L

Long term studies

Daphnia magna

21d-EC10reprod: 0.738 mg/L

Etheramine acetate

 73.8 µg/L

Pseudokirchneriella subcapitata

72h-ErC10: 0.0421 mg/L

Etheramine

 4.21 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 was > 60% oxidation after 28 days.

Bioaccumulation potential

The very low log Kow of -0.34 suggests that the substance has a low bioaccumulation potential.

Conclusion classification according to CLP Regulation 1272/2008

Based on the results of the acute aquatic toxicity tests (values < 1 mg/L) the substance is classified with Category Acute 1 (M-factor 100, as 0.001 < ErC50corrected for river water < 0.01 mg/L).

Based on the results of the chronic aquatic toxicity (0.001< ErC10corrected for river water < 0.01 mg/L) and since the substance has a low bioaccumulation potential and is rapidly biodegradable, the substance is classified with Category Chronic 1 (M-factor 1). 

Classification according to 67/548/EEC (DSD)

Acute aquatic toxicity is < 1 mg/L and the substance is rapidly biodegradable and has a low bioaccumulation potential (log Kow of -0.34). Therefore the substance is classified with N; R50.