Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
251 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
172 µg/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:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
89 µg/kg food
Assessment factor:
90

Additional information

General discusssion

As long-term NOECs from species representing two trophic levels are available (algae and daphnia) and these results cover the level showing the lowest EC50 in short term tests, an assessment factor of 50 may be used. However based on the observed lower toxicity to fish not only for the alkyl-1,3 -diaminopropanes but also for primary fatty amines and mono and dialkyl quats it is considered unlikely that fish toxicity will be critical for alkyl-1,3 -diaminopropanes. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the alkyl-1,3-diaminopropanes 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 ecotoxicity data for several cationic surfactants the use of safety factor of 10 is justified for the derivation of the PNECaquatic,bulk.

The PNECsediment and the PNECsoil are derived on the basis of experimental data and the application of the appropriate assessment factor according to REACH guidance.

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 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)Cxto correct for the lower ecotoxicity observed. Algae are in general the most sensitive species and are therefore for most of the alkyl-1,3-diaminopropanes basis for classification. It should be noted that the 21 day daphnia EC50(parental mortality) is included in the table below for classification purposes as a worst-case in the absence of reliable 48 day EC50values. The lowest chronic NOEC for (Z)-N-9 -octdecenyl-1,3 -diamopropane is 100 µg/L (21d daphnia test in riverwater). Correcting this value for mitigation with the realistic worst-case correction factor of 10 leads to NOEC/EC10 for classification of 10 µg/L.

Available river water EC50 data algae and chronic daphnia used for classification

Alkyl-1,3-diaminopropanes

CAS number

72 h algae

ERC50(µg/L)

21 d daphnia

EC50

(µg/L)

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

 (Z)-N-9 -octdecenyl-1,3 -diaminopropane

7173 -62 -8

507

290

29

Amines, N-C16 -18-alkyltrimethylenedi-

1219010-04-4

507

290

29

Figures in bold are based on read-across.

 

Available river water EC10/NOEC data algae and chronic daphnia used for classification

Alkyl-1,3-diaminopropanes

CAS number

72 h algae

ERC10(µg/L)

21 d daphnia

NOEC

(µg/L)

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

 (Z)-N-9 -octdecenyl-1,3 -diaminopropane

7173 -62 -8

188

100

10

 Amines, N-C16 -18-alkyltrimethylenedi-

1219010-04-4

188

100

10

Figures in bold are based on read-across.

  

Biodegradability

Based on the available studies on biodegradation, the substances are estimated to be readily biodegradable. The 10-days-window criterion does not need to be evaluated for the cationic surfactants under consideration as they are UVCB substances.

 

Bioconcentration factor

No measured BCF for fish is available. Standard OECD 305 tests are technically not feasible with the strongly sorbing easily biodegradable substances. The log Kow values provided in the dossier are however acceptable. The BCF was therefore calculated using the BCFBAF v3.0 estimation program as included in EPIweb v4.0. In addition based on information of kinetics in mammals and for n-hexadecyl amine in fish and the general properties of surfactants, a high bioaccumulation potential is not expected.

Measured log Kow values for alkyl-1,3,diaminopropane technical products and the calculated log BCF based on the measured log Kow.

Alkyl-1,3-diaminopropanes

CAS number

Slow stirring 

log Kow

Calculated BCF (EPI v4.0)

 (Z)-N-9 -octdecenyl-1,3 -diaminopropane

7173 -62 -8

-0.0

4.6

Amines, N-C16 -18-alkyltrimethylenedi-

1219010-04-4

-0.0

4.6

Figures in bold are based on read-across.

Conclusion on classification

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

As all acute ecotoxicity values (corrected and uncorrected) as given in the Table above are below 1 mg/L and the diamines are ‘readily biodegradable’ and have a low bioaccumulation potential based on the measured log Kow values, the environmental classification for (Z)-N-9 -octadecenyl-1,3-diaminopropane andN-C16-18-alkyl-(evennumbered) C18 unsaturated-1,3-diaminopropane is:

:

Acute (short-term) aquatic hazard Acute Category 1

The corresponding M-factor is 10 based on the EC50 of 29 ug/L (21 d EC50 parental daphnia riverwater test of 290 ug/L corrected with factor of 10)

When chronic toxicity data are available these should be used for classification for chronic aquatic hazard. Considering the lower sensitivity of fish it is considered justified to use the long-term daphnia and algae test results for the chronic classification. (Z)-N-9 -octadecenyl-1,3-diaminopropane and N-C16-18-alkyl-(evennumbered) C18 unsaturated-1,3-diaminopropane are bothreadily biodegradable and the lowest EC10/NOEC is 100 µg/L (21d daphnia test in riverwater). Correcting this value for mitigation with the realistic worst-case correction factor of 10 leads to NOEC/EC10 for classification of 10 µg/L. The substance should be classified with:

Chronic (Long-term) aquatic hazard Chronic Category 1

 

The corresponding M-factor is 1 based on the EC10/NOEC of 10 µg/L (21d NOEC daphnia riverwater test of 100 µg/L corrected with factor of 10)

 

 

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

As all ecotoxicity values (corrected and uncorrected) are below 1 mg/L. Based on these results it is proposed to classify (Z)-N-9 -octadecenyl-1,3-diaminopropane and N-C16-18-alkyl-(evennumbered) C18 unsaturated-1,3-diaminopropane asR50.

Alkyl-1,3-diaminopropanes are readily biodegradable. The measured log Kow <3 and calculated BCF <100 L/kg which means that an R53 does not need to be assigned.

This leads to the following environmental classification according DSD for (Z)-N-9 -octadecenyl-1,3-diaminopropane and N-C16-18-alkyl-(evennumbered) C18 unsaturated-1,3-diaminopropane is:

.

 N, R50