Reactive Blue F08-0170

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.1 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.01 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

10 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.085 mg/kg sediment dw

Extrapolation method:

sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.009 mg/kg sediment dw

Extrapolation method:

sensitivity distribution

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.02 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

5 mg/kg food

Assessment factor:

300

Additional information

General discussion

The acute toxicity of REACTIVE BLUE F08-0170 was assessed with an acute immobilisation test on Daphnia magna, over an exposure period of 48 hours in a static test. Toxic effects were not observed during the preliminary concentration range-finding test therefore a limit test was performed in the main experiment using only one test concentration (100 mg/L nominal) and one control group. The measured concentration (based on mean value of four test item components) was 102 mg/L at the start and 84 mg/L at the end of the test. As the measured concentration deviated not more than 20 per cent from the nominal value during the experiment, the biological results are based on the nominal concentration. Based on the results of this study, REACTIVE BLUE F08-0170 had no toxic effect on Daphnia up to at least the tested concentration level of 100 mg/L (EC50 > 100 mg/L and NOEC = 100 mg/L).

The effect of REACTIVE BLUE F08-0170 test item was assessed on algal growth using the unicellular green alga Pseudokirchneriella subcapitata (Selenastrum capricornutum), over an exposure period of 72 hours. As the test item is a highly water soluble deep-coloured dye and the amount of light for photosynthesis is likely to be significantly affected by the shading effect of the coloured test solution, a modified test was performed in order to separate the physical effect of the coloured material from its true toxic effects. The results of this experiment showed that the majority of the observed inhibition effect was related to the light absorption by the test item.However, a greater inhibition was seen at 72 hours when REACTIVE BLUE F08-0170 was in contact with the algae cells for 72 hours. This indicates that there was also a toxic effect on the growth of the alga (Pseudokirchneriella subcapitata). As the measured concentrations deviated not more than 20 per cent from the nominal in most cases, the biological results were based on the nominal concentrations. The 72 hr EC50 (growth rate) is considered to be > 200 mg/L (nominal).

An acute fish toxicity test of REACTIVE BLUE F08 -0170 was conducted according to OECD Guidelines for the Testing of Chemicals, 203 Fish Acute Toxicity Test. The 96h-LC50 of the test substance to Zebra fish (Brachydanio rerio) was > 148.2 mg/L (calculated based on the geometric mean of actual concentration of main constituent).

Conclusion on classification

The environmental studies conducted on the substance have all been ranked reliability 1 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.

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

 

The substance is therefore proposed to be “not classified” and appropriate comments are detailed within Section 2 of the registration dossier.