Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 500 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.692 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.169 mg/kg sediment dw
Assessment factor:
500
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:
5 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
2 mg/kg food
Assessment factor:
300

Additional information

All endpoints are based on measured data applying assessment factors.

The PNECaquatic 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 for primary fatty amine ethoxylates it is considered unlikely that fish toxicity will be critical for primary fatty amine ethoxylates. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the primary fatty amine ethoxylates 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. For primary fatty amine ethoxylates a safety factor of 50 is applied for the derivation of the PNECaquatic, bulk

The PNECsed and soil values calculated using the EPM method were till recently considered of lower reliability for ionic substances. Chen et al., 2014 have shown that for a quaternary ammonium compound the concentration of the unbound chemical (i.e., the freely dissolved concentration) is the relevant dose parameter and that thus effects for sediment and soil organisms can be predicted using the EPM without additional correction factor of 10 for additional exposure via ingestion as long as the pore water concentration is correctly predicted. Because of the availability of a measured equilibrium distribution coefficient between water and soil the use of the EPM without the additional correction factor of 10 is considered to be justified.

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 DOC and suspended matter, is data obtained under standard test conditions prefered for classification and labeling purposes. If no data obtained under standard conditions is available the results of tests performed in natural river water can be corrected for the mitigation using a worst-case factor of 10 to the L(E)C50.

Table Available algae, daphnia and fish test results.

Primary fatty amines ethoxylates

CAS number

96 h

Fish

LC50

(µg/L)

72 h algae

ERC50(µg/L)

72 h algae

ERC10/ NOEC (µg/L)

48 h daphnia

EC50

(µg/L)

21 d daphnia

EC50

(µg/L)

21 d daphnia

EC10/ NOEC

(µg/L)

EC50 (µg/L) used for Classification

 

EC10 (µg/L) used for classification

 

2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol

25307-17-9

390

100

86.7

53.8

34.1

15.6

43

301

10.7

53.8

 15.6

Figures given in italic and underlined are performed in reconstituted lab water. The other endpoints were obtained by performing tests in natural river water.

Biodegradability

The primary fatty amine ethoxylates are readily biodegradable.

Bioaccumulation potential

No measured BCF fish is available for the primary fatty amine ethoxylates. Standard OECD 305 tests are technically very complicated with these strongly sorbing easily biodegradable substances. Three valid measured log Kow values are however available as presented in the table below.

primary fatty amines ethoxylates

CAS number

Measured Log Kow

2,2'-(C12-18 evennumbered alkyl imino) diethanol

71786-60-2

0.7

2,2'-(C16-18 (evennumbered) alkyl imino) diethanol

1218787-30-4

3.6

2,2’(octadec-9-enylimino)-bisethanol

25307-17-9

3.4

 

The highest log Kow is observed for 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol (CAS no 1218787-30-4). For this product has also the lowest CMC of 3.5 mg/L was observed. The measuredlog Kow value of 3.6 indicates a moderate bioaccumulation potential for narcotic substances. For polar narcotics like the primary fatty amine ethoxylates however there is only limited information on the relationship between log Kow and BCF. The observed rapid biotransformation of the C12 to C18 alkyldiethanol amines demonstrates that it will be very unlikely that these substances will accumulate in fish. This was confirmed by the calculated BCF values which where were all below the CLP threshold value of 500 L/kg.

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. Primary fatty amine ethoxylates are all ‘readily biodegradable’ and have a measured 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 accordingfor n-Primary alkyl amines ethoxylates

Acute (short-term) aquatic hazard category 1

M factor 10

Chronic aquatic hazard category 1

M factor 1