Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2.8 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:
0.28 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.69 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 for di (2 -hydroxypropyl)tallow amine or read-across from di (2 -hydroxyethyl)oleyl amine applying the appropriate assessment factors. The PNEC sediment is both calculated using the equilibrium partition coefficient method and based on the sediment test result available for di (2 -hydroxyethyl)oleyl amine. The test result is used for risk assessment purposes. Also for fish and earthworms the toxicity data is read-across from primary fatty amine ethoxylate di (2 -hydroxyethyl) oleylamine. A justification for read-across is included in IUCLID Chapter 13.

The PNECaquatic bulk is calculated using the standard 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. Based on the observed comparable or lower toxicity to fish for primary fatty amine ethoxylates, when compared to the toxicity to daphnia and algae, it is considered unlikely that fish toxicity will be critical for primary fatty amine propoxylates (as observed for the 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 propoxylates 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 propoxylates 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 DOC and 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 and 2)

primary fatty amines Propoxylates

CAS number

96 h

Fish

LC50

(mg/L)

72 h algae

ERC50(µg/L)

72 h algae

ERC10(µg/L)

48 h daphnia

EC50

(µg/L)

21 d daphnia

EC50

(µg/L)

21 d daphnia

EC10(µg/L)

EC50corr(µg/L) (corrected for Classification with Factor 10)

 di (2 -hydroxypropyl) tallowamine

68951-72-4 (old)

1309955-79-0 (new)

0.1* 

340**

 170**

480**

140**

34

*Read-across from di (2 -hydroxyethyl) oleylamine (= 2,2'-(Octadecylimino)bisethanol; CAS no 25307-17-9)

** figures in bold are based on tests in natural river water. The endpoint value is divided by a factor of 10 as worst-case to correct for the mitigation which might be due to the use of natural river water.

Biodegradability

Di (2 -hydroxypropyl) tallowamine is readily biodegrable.

Bioaccumulation potential

No measured BCF fish is available for the primary fatty amine propoxylates. Standard OECD 305 tests are technically very complicated with substances which are sorbing and easily biodegradable. For two pH conditions valid measured log Kow values are however available as presented in the table below. For allow comparison the by EPIsuite (V4.0) calculated Log Kow for the protonated structures is included in the table.

 

primary fatty amines propoxylates

Measured Log Kow

(at pH 7)

Measured Log Kow

(at pH 3 - 4)

Calculated

Log Kow

(EPIsuite)

Di (2-hydroxypropyl)hexadecylamine

5.7

3.3

3.93

Di (2-hydroxypropyl)octadecenylamine

6.1

3.6

4.7

Di (2-hydroxypropyl)octadecylamine

6.9

4.4

4.9

Di (2-hydroxypropyl)tallow amine

6.2

3.7

4.5

The highest log Kow is observed for di (2 -hydroxypropyl)octadecyl amine. For this product a pKa was calculated of 5.73. For di (2 -hydroxypropyl) octadecyl amine also the lowest water solubility of 0.15 mg/L was observed. The measured log Kow value of 6.2 indicates a bioaccumulation potential if this substance would have been a narcotic substance. For polar narcotics like the primary fatty amine propoxylates 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 propoxylates also similar metabolisation rates are expected. 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 6.2 the BCFBAF model predicts a BCF of 20880 L/kg wwt without metabolism and 148.6 L/kg wwt with metabolism.

Classification according (Classification, Labeling & Packaging Directive286/2011/EC)

Short term data: L(E)C50for Fish, daphnia and algae: resp. 0.1, 0.048 and 0.034 mg/L (corrected with factor 10 for mitigation). As all acute ecotoxicity values (corrected and uncorrected) are below 1 mg/L the substances should be classified as acute aquatic hazard category 1. 

Long term data: EC10 for daphnia and algae: resp. 0.014 and 0.017 mg/L (corrected with factor 10 for mitigation). Di (2 -hydroxypropyl)tallow amine is ‘readily biodegradable’ and has a measured log Kow 6.2 at pH 7. No long-term fish data is available and fish are slightly less or equally sensitive when compared to algae or daphnia. It is however unlikely that the long-term fish EC10will be lower than 0.01 mg/L. The long-term toxicity range for bis (2-hydroxypropyl)tallow amine is in the range of > 0.01 to ≤ 0.1 mg/L i.e. Category Chronic 2.

This leads to the following environmental classification for bis (2-hydroxypropyl)tallow amine

Acute (short-term) aquatic hazard category 1

M factor 10

Chronic (long-term) aquatic hazard category 2

no M factor is warranted

based on the long term toxicity data