Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2 200 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 bulkis 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

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 L(E)C50to correct for the lower ecotoxicity observed.

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

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)

EC10corr(µg/L) (corrected for Classification with Factor 10)

2,2'-(C12-14 evennumbered alkyl imino) diethanol

61791 -31 -9

 100*

107

9.16 

 

405

279

0.916

 * 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

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'-(C12-14 evennumbered alkyl imino) diethanol

1.5

 

The log Kow observed for 2,2'-(C12 -18 (evennumbered) alkyl imino) diethanol (CAS no 71786 -60 -2) is 0.7 (slow stirring). This measured log Kow value indicates a low 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.

For hexadecyl amine rapid metabilisation in fish is anticipated based on in vitro metabolism test results with this substance (Kmet= 0.152 1/d; Bernard et al., 2006). Based on the structural similarity and ready biodegradability of the primary fatty amine ethoxylates similar metabolisation rates are expected for the primary fatty amine ethoxylates. 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) allows the inclusion of metabolism into the BCF calculation but the results of this model should be considered with care as the training set holds only a limited number of substances which can reliably be used to predict the fate of cationic surfactants. With a log Kow of 0.7 the BCF model predicts a BCF of 3.16 L/kg (without metabolism).

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 10