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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.043 µg/L
Assessment factor:
100
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:
1.692 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 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 earthworms the toxicity data is read-across from primary fatty amine ethoxylate di (2 -hydroxyethyl) oleylamine (CAS 25307-17-9). A justification for read-across is included in IUCLID Chapter 13.


All endpoints are based on measured data applying assessment factors.

Conclusion on classification

Ecotoxicity


Aquatic ecotoxicity tests have been performed in standard test media to quantify the intrinsic toxicity for C&L purposes and in natural riverwater to derive the PNECaquatic-bulk to be used for environmental risk assessment purposes. The reasoning why this PNECaquatic-bulk is derived is explained in the next paragraph and in the endpoint summaries of the algae and long term daphnia tests. 


Due to intrinsic properties of amine containing cationic surfactants river water ecotoxicity tests deliver more reproducible test results with limited uncertainty. River water has a mitigating effect on ecotoxicity due to sorption of the amines to DOC and suspended matter. For this reason, data obtained under standard test conditions is 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 .


 


More details on the use of the bulk approach are described in a document attached to IUCLID chapter 13.


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
















































































































































































































PFAPO-T (2-[(2-hydroxypropyl)(C16-18 sat. C18 unsat. alkyl)amino]propan-1-ol, (EC 695-977-9, CAS 1309955-79-0, old CAS 68951-72-4))



 



nominal


 



TWA


 



 



EC(L)50/L(L)C50



EC(L)10/NOEC(L)



EC50



EC10/NOEC



 



(µg/L)



(µg/L)



(µg/L)



(µg/L)



Algae test (2010)



273**



137**



 



 



Bulk-approach static



 



 



 



 



Akzo Nobel



 



 



 



 



(CAS 68951-72-4, old CAS)



 



 



 



 



Algae test (2022)


3615.872.020.284

WAF-approach static



 



 



 



 



Noack



 



 



 



 



New CAS no.: 1309955-79-0



 



 



 



 



Short term daphnia test (2022)


waived waived 

Acute fish test (2022)



waived



 



waived



 



Long-term fish (2022)


19.55.016.34.25

Flow-through



overall survival


overall survivaloverall survival

Noack



 



 



 



 



New CAS no.: 1309955-79-0



 



 



 



 


Long-term daphnia test (2012)

480**



140**



 



 



Bulk-approach semi-static



 



 



 



 



Akzo Nobel


    

(CAS 68951-72-4, old CAS)


   

Long-term daphnia test (2022)


187415048.17.45

WAF approach semi-static


    

Noack


    

New CAS no.: 1309955-79-0


    

Toxicity to microorganisms (2010)



169000



31550



 



 



Geerts (2010)



 



 



 



 



3h-ECx



 



 



 



 



 (CAS 90367-28-5, old CAS)



 



 



 



 



** 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)


 


 









































Acute toxicity



 



 



Hazard



M-factor



EC50 = 16.3 µg/L (TWA, long term fish)



 



 



H400



10



readily biodegradable



 



 



 



 



Chronic toxicity



 



 



Hazard



M-factor



EC10 = 4.25 µg/L (TWA, long term fish)



 



 



H410



1