Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

In conclusion, the test item C.I. Leuco Sulphur Brown 37 had no acute toxic effects on zebra fish under the present test conditions at the theoretical concentration of 50 mg/L. This concentration corresponds to the lowest EC50 value obtained in the test with daphnia. According to the threshold approach it was demonstrated, that zebra fish is not the most sensitive species for C.I. Leuco Sulphur Brown 37.

Key value for chemical safety assessment

Additional information

The acute toxicity of the test itemC.I. Leuco Sulphur Brown 37to zebra fish (Brachydanio rerio) was determined in a 96‑hour semi-static test with daily test medium renewal according to the EU Commission Directive 92/69/, Part C.1, the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992).

A limit test was performed in accordance with the threshold approach requiring that the fish test is performed with a single concentration close to or slightly higher than the lowest EC50value obtained in tests with in this case lemna and daphnia. The threshold approach (based on the Guidance on Information Requirements and Chemical Safety Assessment, ECHA (2008)) was used to demonstrate that zebra fish is not the most sensitive species forC.I. Leuco Sulphur Brown 37.

 

TheEC50value for C.I. Leuco Sulphur Brown 37 in a lemna 7-day growth inhibition test was >100 mg/L (based on theoretical concentrations, Harlan Study No. D55221). The lowest EC50value for C.I. Leuco Sulphur Brown 37 was obtained in a daphnia 48-hour immobilization test (Harlan Study No. D55210) and was 48 mg/L (based on theoretical concentrations). Basedon this, the theoretical concentration tested in the present study with zebra fish was50 mgC.I. Leuco Sulphur Brown 37/L (dilution 1:2).

 

Due to the low water solubility of the test item, a dispersion of the test item with the loading rate of 100 mg/L was ultrasonic treated for 15 minutes and continuously stirred at room temperature in the dark over 96 hours. Then, the dispersion was filtered. The dilution 1:2 of the undiluted filtrate with the loading rate of 100 mg/L was used as test medium. This corresponds to a theoretical concentration of 50 mg/L. Additionally, a control was tested in parallel.

 

The preparation of the test media was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (2000).

 

The biological test results (based on theoretical concentrations) after 96 hours exposure:

 

– 96-hour LC50:

>50 mg/L

 

 

– 96-hour LC0:

>=50 mg/L

 

 

– 96-hour LC100:

>50 mg/L

 

 

– 96-hour NOEC:

>=50 mg/L

 

 

– 96-hour LOEC:

>50 mg/L

 

In conclusion, the test itemC.I. Leuco Sulphur Brown 37had no acute toxic effects on zebra fish under the present test conditions at the theoretical concentration of 50 mg/L. This concentration corresponds to the lowest EC50value obtained in the test with daphnia. According to the threshold approach it was demonstrated, that zebra fish is not the most sensitive species forC.I. Leuco Sulphur Brown 37.