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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
After receiving the final decision the lab was contacted on 10th of September 2020 and the study was finally ordered on 24th of September 2020 with delivery date in February 2021.
Due to an internal delay at the testing laboratory the study could not be delivered in time. Details can be found in the attached letter from the lab.
The range-finding-study is finished and the results are included in a second endpoint study record. The completion of the full study is planned in April 2021 with immediate update of the dossier.
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Principles of method if other than guideline:
non-GLP range-finding study
main study started
GLP compliance:
no
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
1.1 Test Water
Reconstituted Water
(Elendt "M4"):
Analytical grade salts and additives will be added at the following nominal concentrations in deionised water:
Main Compounds
Trace Elements Vitamins
CaCl2·2 H2O 293.80 mg/L H3BO3 2860 µg/L Thiamin HCl 75.0 µg/L
MgSO4·7 H2O 123.30 mg/L MnCl2·4 H2O 361 µg/L Cyanocobalamin (B12) 1.0 µg/L
KCl 5.80 mg/L LiCl 306 µg/L Biotin (B6) 0.75 µg/L
NaHCO3 64.80 mg/L RbCl 71 µg/L
Na2SiO3·9 H2O 10.00 mg/L SrCl2·6 H2O 152 µg/L
NaNO3 0.27 mg/L NaBr 16 µg/L
KH2PO4 0.14 mg/L Na2MoO4·2 H2O 63 µg/L
K2HPO4 0.18 mg/L CuCl2·2 H2O 17 µg/L
ZnCl2 13 µg/L
CoCl2·6 H2O 10 µg/L
KI 3.3 µg/L
Na2SeO3 2.2 µg/L
NH4VO3 0.6 µg/L
Na2EDTA·2 H2O 2.5 mg/L
FeSO4·7 H2O 1.0 mg/L
Test organisms (species):
Daphnia magna
Details on test organisms:
Species: Daphnia magna (Straus), clone 5

Age at Test Start: Less than 24 hours old

Origin: The daphnids introduced in the test will be taken from in-house laboratory culture.
Breeding Conditions: The daphnids are bred in the laboratories under similar temperature and light conditions as used in the test. The cultivation of the parental daphnids is performed in Elendt M4 medium. The test organisms will not be first brood progeny. The daphnids in the stock culture are fed at least on all working days with green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.

Reference Item: For the evaluation of the quality of the Daphnia clone and the consistency of the experimental conditions, the reference item potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.

Acclimatisation: Is not necessary since the breeding is performed in the same water.

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
18 °C - 22 °C with a maximum deviation of ± 1 °C within this range.
pH:
pH 6 – 9
Dissolved oxygen:
> 3 mg/L
Nominal and measured concentrations:
Nominal: 0.0075, 0.075, 0.75 and 7.5 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 2.9 µg/L
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on geomean measured value of C14 compound
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Based on geomean measured value of C14 compound
Details on results:
s. result tables

Solubility and adsorption results


The recovery of the main test item constituent 2,2’(dodecylimino)bisethanol was compared for freshly prepared and aged test solutions between a pre-saturated and a non pre-saturated test beaker. Therefore, a test item concentration of 10 mg/L was added to a 30 minutes pre-saturated test beaker and a non-pre saturated test beaker.  Samples were taken directly after preparation and after 24 hours for analytical verification.


Neither the concentration nor the stability of 2,2’(dodecylimino)bisethanol was significantly different between pre- and non pre-saturated test beaker for both sampling points. Therefore, no pre-saturation was applied for the range-finder test.


 


Biological range-finder results

















































































































































        
        
        

Daphnia acute test


      

 



 



 


        

Test Item



No. of Daphnia tested



No.  Immobilised



% immobilisation



Observation



Concentration [mg/L]



24 h



48 h



24 h



48 h



24 h



48 h



 



 



 



 



 



 



 



 



 



 


 

 


  

 


 

Control



10



0



0



0



0



0



0



0,0075



10



0



0



0



0



0



0



0,075



10



0



0



0



0



0



0



0,75



10



5



4



50



40



SL(5)



SL(6)



7,5



10



10



10



100



100



0



0























Observations


 

0 = No abnormalities



SL = Slow movement



(in parenthis number of daphnia



 with sublethal effects)



 


Analytical range-finder results













































































































































































































































































































Table 3. Results for the Determination of Laurydiethanolamine of the Test Item in the Test Samples (Daphnia)



 



 



Sample Description



Concentration


 

Concentration



Concentration


 

Mean measured


 

Sampling



Age



found


 

calculated



nominal



% of



Concentration



[µg test item/L]



day



[h]



[µg a.i./L]1



D.F.



[µg a.i./L]1



[µg a.i./L]2



nominal1



[µg test item/L]



Control



0



0



<LOD



2



n.a.



0,000



n.a.


 

Control



2



48



<LOD



2



n.a.



0,000



n.a.


 

7,5



0



0



2,823



2



5,645



5,685



99


 

7,5



2



48



<LOD



2



n.a.



5,685



0,07



LOD used


     

mean value (n=2):



50



3,73


      

RSD (n=2):



141


 

75



0



0



28,468



2



56,936



56,850



100


 

75



2



48



18,391



2



36,782



56,850



65


 
     

mean value (n=2):



82



61,8


      

RSD (n=2):



30


 

750



0



0



27,714



20



554,279



568,500



97


 

750



2



48



25,246



20



504,922



568,500



89


 
     

mean value (n=2):



93



699


      

RSD (n=2):



7


 

7500



0



0



29,771



200



5954,104



5685,000



105


 

7500



2



48



29,976



200



5995,235



5685,000



105


 
     

mean value (n=2):



105



7882


      

RSD (n=2):



0



 



 



 



 



 



 



overall mean value (n=8):



83


 

 



 



 



 



 



RSD (n=8):



43



 


         

1 The tabulated results represent rounded results calculated on the exact raw data



2 Nominal values calculated using content given in analytical certificate


  

LOD: Limit of detection = approx. 0.5 µg test item/L


   

LOQ: Limit of Quantification = 25 µg test item/L


   

n.a.: not applicable; RSD: Relative Standard Deviation; D.F.: Dilution factor


 

a.i.: Laurylditethanolamine


     

 













































































































































































































































































































Table 4. Results for the Determination of Tetradecyldiethanolamine of the Test Item in the Test Samples (Daphnia)



 



 



Sample Description



Concentration


 

Concentration



Concentration


 

Mean measured


 

Sampling



Age



found


 

calculated



nominal



% of



Concentration



[µg test item/L]



day



[h]



[µg a.i./L]1



D.F.



[µg a.i./L]1



[µg a.i./L]2



nominal1



[µg test item/L]



Control



0



0



<LOD



2



n.a.



0,000



n.a.


 

Control



2



48



<LOD



2



n.a.



0,000



n.a.


 

7,5



0



0



0,588



2



1,177



1,523



77


 

7,5



2



48



<LOD



2



n.a.



5,685



0,07



LOD used


     

mean value (n=2):



39



2,90


      

RSD (n=2):



141


 

75



0



0



6,992



2



13,985



15,225



92


 

75



2



48



1,832



2



3,665



15,225



24


 
     

mean value (n=2):



58



43,5


      

RSD (n=2):



83


 

750



0



0



7,206



20



144,124



152,250



95


 

750



2



48



5,026



20



100,518



152,250



66


 
     

mean value (n=2):



80



603


      

RSD (n=2):



25


 

7500



0



0



8,232



200



1646,444



1522,500



108


 

7500



2



48



7,805



200



1560,943



1522,500



103


 
     

mean value (n=2):



105



7900


      

RSD (n=2):



4



 



 



 



 



 



 



overall mean value (n=8):



71


 

 



 



 



 



 



RSD (n=8):



55



 


         

1 The tabulated results represent rounded results calculated on the exact raw data



2 Nominal values calculated using content given in analytical certificate


  

LOD: Limit of detection = approx. 0.5 µg test item/L


   

LOQ: Limit of Quantification = 25 µg test item/L


   

n.a.: not applicable; RSD: Relative Standard Deviation; D.F.: Dilution factor


 

a.i.: Laurylditethanolamine


     

 

Conclusions:
A range finding study according to OECD202 resulted in an EC50 of 600 µg/L.

Description of key information

A range finding study according to OECD202 resulted in an EC50 of 600 µg/L.


The full study was delayed and the results will be provided in an additional update shortly. 

Key value for chemical safety assessment

Additional information