Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The test item is an UVCB substance with a low water solubility of 25 mg/l. Therefore a specific analysis e.g. with LC-MS/MS could not be performed reliably.


In the table below the available acute and chronic ecotoxicity data for all three trophic levels are given:






















































Test



Guideline



Endpoint



Value



 



 



 



(mg/L)



Acute Fish



203



LC50 (96h)



>5000 (NOEC=5000mg/l)



Acute Daphnia



202



EL50 (48h)



>100 (NOEL=100mg/l)



Algae



201



ErL50 (72h)



>100 (NOEL=31.6)



Microorganisms



209



NOEC (3h)



1000



 



 



 



 



Algae



201



ErL10 (72h)



47.3



 


All acute and chronic freshwater test results are > 1 mg/L.


 


Daphnia&Algae


In view of the difficulties associated with the evaluation of aquatic toxicity of poorly water soluble test items, a modification of the standard method for the preparation of aqueous media was performed for daphnia and algae tests. An approach endorsed by several important regulatory authorities in the EU and elsewhere (ECETOC 1996 and OECD 2000), is to expose the organisms to a Water Accommodated Fraction (WAF) of the test item in cases where the test item is a complex mixture and is poorly soluble in water and in the permitted solvents. Analytical verification was done by TOC measurement.


 


In the daphnia limit test (OECD202) no effects were observed up to the nominal loading rate of 100 mg/l corresponding to a TOC measured concentration on 68.5 mg/l.


 


In the algae test (OECD201) no effects were observed up to the nominal loading rate of 31.6 mg/l corresponding to a TOC measured concentration on 14.6 mg/l. ErL50 has been determined to be >100mg/l nominal loading rate corresponding to a TOC measured concentration on 51.4 mg/l.


 


Fish


No effects are observed up to the limit test of 5000mg/l without analytical verification in an acute fish test according to OECD203.


 


Microorganism


No effects are observed up to the highest nominal test concentration of 1000mg/l without analytical verification performed with a structural analogous substance according to OECD209.


 


CONCLUSION


Fish, Daphnia and Algae were tested with the registration substance. Up to the water solubility of the registration substance of 25 mg/L at 20 deg C no ecotoxicty was observed for fish, daphnia, algae and microorganism. Based on this findings no PNECs were derived. For fish, daphnia, algae and microorganisms no hazards were identified in the forementioned tests.