Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
32 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.31 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.2 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.88 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

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

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 toand suspended matter a factor of 10 should be applied to the L(E)C50to correct for the lower ecotoxicity observed. In the absence of sufficient acute daphnia data the 21 d EC50for daphnia is used as basis for the acute classification of the polyamines as a worst-case. Some test results for tests performed in reconstituted lab water are available and these endpoints can therefore directly be used for classification purposes. The only acute fish and daphnia data available are forN-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (CAS no 2372-82-9). For fish a 96 h LC50 of 0.431 mg/L was observed and for daphnia a 48 h EC50 of 0.0775 mg/L.

 

Table   Available algae, daphnia and fish test results (Klimisch 1, 2) for the polyamines.

Polyamines

New CAS number

Old CAS number

72 h algae

ERC50(µg/L)

72 h algae

ERC10/ NOEC (µg/L)

21 d daphnia

EC50

(µg/L)

21 d daphnia

EC10/ NOEC

(µg/L)

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

N-(3-aminopropyl)-N- (C12-18 even numbered) alkyl-propane-1,3-diamine

1219458-12-4

91771-18-5

223

137

342

63.7

34

(Z)-N-(3-aminopropyl)-N'-9-octadecenylpropane-1,3-diamine

28872-01-7

28872-01-7

1090

518

684

810

68

N-(3-aminopropyl)-N'-C16-18 (evennumbered), C18 unsaturated alkyl -propane-1,3-diamine

1219458-14-6

61791-57-9

 

 

 

 

68

(Z)-N-(3-aminopropyl)-N'-[3-(9-octadecenylamino)propyl]propane-1,3-diamine

67228-83-5

67228-83-5

 

 

 

 

68

N-(3-aminopropyl)-N'-[3-(C16-18 (evennumbered), C18 unsaturated alkyl amino)propyl]propane-1,3-diamine

 

1219458-11-3

68911-79-5

2470

1270

974

800

97

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

 

2372-82-9

2372-82-9

15

9.5

34

24

15

N-(3-aminopropyl)-N-tallow alkyltrimethylenediamine

85632-63-9

85632-63-9

914

347

566

320

56.6

Figures given in bold are based on read across; figures given in italic and underlined are performed in reconstituted lab water and these are therefore not corrected.

 

 Biodegradability

Triamines

Only valid ready biodegradability test result for linear and branched triamines is available because these substances are very toxic to micro-organisms. Nevertheless all aspects important for achieving a ready biodegradability test result i. e. 1) ultimate (complete) biodegradation (demonstrated in (S) CAS tests, through read across with triamine C12-18 and branched triamine C12 and intermediates) 2) high rates of degradation (through read across with triamine C12-18/branched triamine C12) and 3) occurrence of competent micro-organisms in unacclimated ecosystems (through read across with triamine C12-18) are fulfilled. All alkyl linear and branched dipropylene triamines should therefore be classified as readily biodegradable (Table). 

Table Typical members of the family of alkyl dipropylene triamine.

 

Chemical name

CAS (old)

Tallow dipropylene triamine

61791-57-9

Cocodipropylene triamine

91771-18-5

Oleyl dipropylene triamine

28872-01-7

N-(3-aminopropyl) -N-dodecylpropane-1,3, diamine

2372-82-9

N-(3-aminopropyl) -N-tallow alkyltrimethylenediamine

85632-63-9

 Compositions of coco and tallow-alkyl chains are specified by Karleskind (1996).

 

Bioconcentration factor

No measured BCF fish is available. Standard OECD 305 tests are technically very complicated with these strongly sorbing completely biodegradable substances. Two valid log Kow values are provided in the dossier. One for triamine C12-18 (CAS no 1219458-12-4) and one for tetramine oleyl (CAS no 67228-83-5). For both a log Kow of -0.3 was observed using the slow stirring method (OECD 123) at pH 6. This log Kow value of -0.3 indicates a low bioaccumulation potential. With this log Kow, a BCF of 3.162 L/kg is calculated using BCFBAF v3.0 estimation program (EPIweb v4.0).

 

Classification according DSD (Dangerous Substance Directive 67/548/)

As all ecotoxicity values (corrected and uncorrected) as given in the Table with ecotoxicity data are below 1 mg/L. Based on these results it is proposed to classify the polyamines asR50.

Based on the available studies on biodegradation, all alkyl dipropylene triamines and N-(3-aminopropyl)-N-alkyl-1,3 diamines are estimated to be readily biodegradable. The measured log Kow -0.3 and calculated BCF of 3.162 L/kg which indicates a low bioaccumulation potential.

This leads to the following environmental classification according DSD for triamines

N, R50

Classification according(Classification, Labeling & Packaging Directive 1272/2008/EC)

As all acute ecotoxicity values (corrected and uncorrected) as given in the Table with ecotoxicity data are below 1 mg/L but the triamines are ‘readily biodegradable’ and the< 500 L/kg, no chronic but an acute classification applies:

This leads to an environmental classification accordingfor linear and branched triamines

                                                               Acute (short-term) aquatic hazard Acute Category 1;

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