Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Non harmful/toxic for fish after short-term exposures

Key value for chemical safety assessment

Additional information

The existing data on Direct Blue 199 sodium salt (i.e. Direct Blue 199_Na) have been taken into account in order to assess the potential for short-term toxicity to fish of Direct Blue 199. The usage of information on Direct Blue 199_Na, which has the same main component and with a different counter ion, can be considered as suitable and appropriated because the difference in salification is expected to not influence the characteristics related to the specific end-point. The impurity profile does not impact on the read across proposed. Details on the approach followed are included in the document attached to the IUCLID section 13.

Direct Blue 199_Na was tested for short-term toxic to fish at different lot concentrations. In some cases the test procedures are scientifically acceptable, while in other many details are missing. In all case there are no evidence that the concentration of the substance being tested has been satisfactorily maintained throughout the tests. The substance is very soluble in water and it does not undergo to readily abiotic degradation, thus it is expected that Direct Blue 199_Na would be bioavailable during the testing period. Despite the Direct Blue 199_Na content in the batches tested was low, it has to be taken into account that the assays were performed at very high concentrations (up to 1000 mg/l).

Despite the reliability cannot be confirmed, in all cases the LC50 recorded was much higher than 100 mg/l.