Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acute tests on all three trophic levels were performed to examine the aquatic toxicity of the test substance. In all cases no toxic effect could be detected in the range of the water solubility of the test substance. The EC50 of the test compound on activated sludge was determined to be above 100 mg/L (nominal concentration).

The NOEC for the reproduction of Daphnia magna of two related compounds in long term guideline studies were found to exceed the water solubility of the substance.

 

In addition, the calculated logPow values of the substance are >> 4.5, which means there is no correlation any more between the logPow and the bioaccumulation. Moreover, the water solubility is very low (< 1 x 10-4 g/L at 20°C).

 

According to toxicological studies, the substance is considered to be not bioavailable because none of the findings in the subacute oral toxicity study are indicative of absorption. In contrast, fecal elimination as shown by reddish discoloration is visualized at high doses.

The pigment is of a molecular weight that does not exclude absorption (857.41) but the pigments form aggregates that are too large to penetrate bio-membranes. For soluble dyestuffs, non-specific discoloration of organs and plasma is usually observed, however this is not the case for the substance.

The substance is likely not to be able to cross biological membrane and therefore does not have any potential to bioaccumulate.

 

In conclusion, the test substance does not cause long-term adverse effects in the aquatic environment and is considered to be not bioavailable (there is no risk for bioaccumulation).

The absence of chronic toxicity effects at the solubility limit in the prolonged toxicity studies with daphnia, the very high logPow and the low water solubility as well as the toxicological findings provide scientific evidence that the substance will not constitute a potential long-term and/or delayed danger to the aquatic environment.