Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

no hazard identified

PNEC value:

0.1 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

Marine water

Hazard assessment conclusion:

no hazard identified

PNEC value:

0.01 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

no hazard identified

PNEC value:

10 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

no hazard identified

Sediment (marine water)

Hazard assessment conclusion:

no hazard identified

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

6.67 mg/kg food

Assessment factor:

300

Additional information

The aquatic toxicity of Reactive Blue 220 was tested in fish and Bacteria.

Zebrafish (Danio rerio) were exposed for 96 hours to 500 mg/L of Reactive Blue 220. To determine the matter content, samples were taken at the beginning of the experiment and after 48 and 96 hours from the centre of the vessels. The geometrical means of the concentration analyses resulted in 511 mg/L and therefore were above the requested 80% of the nominal concentration. No deaths were observed either in the control or the 500 mg/L test group. Hence, the LC50 after 48 and 96 hours is higher than 500mg/L.

Determination of toxicity to bacteria ("Bacterial toxicity") was done in the inhibition of oxygen respiration ("Robra-Test") with activated sludge from wastewater treatment plants up to a concentration of 1000 mg/L Reactive Blue 220. The evaluation of the inhibition of the oxygen rate consumption after 3 hours of exposure of the bacteria to the test material did not lead to any adverse effects up to the highest dose tested. Hence, the NOEC after 3 hours is higher than 1000 mg/L.

The potential toxicity of Reactive Blue 220 to daphnids and algae was assessed via read across from a structural analogue.

The study to evaluate the potential toxicity of the test substance to daphnids was conducted with a structural analogue according to EU test guidance 67/548/EEC part C2 in compliance with GLP. The EC0 of the test substance after was >= 100 mg/L nominally and >= 70 mg/L in the mean of the analytical determined values. The analytical content of < 80% of the nominal value is due to the fact that the test substance hydrolyses easily from the ester and vinyl structure to the alcohol of the dyestuff, which was not taken into account analyzing the substance content. Due to the fact that the EC0 is >= 70 mg/L without any adverse effects on the daphnids, it can be concluded that also the EC50 of the test substance is >100 mg/L. Hence, the substance is not considered to pose a hazard to Daphnia.

The test for growth inhibition on algae according to the EU-guideline, was supplemented by a modified algae test which takes into account the light absorption of the dyes (modified algae test according to Memmert & Knoell (1992)). For both tests, test item concentrations of nominally 12.5, 25, 50, and 100 mg/L of the structural analogue were used. With this method, it is possible to differentiate algicidic from algistatic effects. Investigation of the effects of light absorption of the dyestuff indicates that effects noted in the algal study are due to light absorption rather than associated toxicity. On this basis the substance is not deemed to be toxic to algae.

Conclusion on classification

The environmental studies conducted on the substance have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

Given the revised results for the Algae study, the results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute environmental effects is therefore required.