Registration Dossier

Administrative data

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:
0.08 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.008 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

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:
2.1 mg/kg food
Assessment factor:
300

Additional information

An acute fish toxicity test was conducted with the substance in accordance with OECD Guideline 203 and in compliance with the Good Laboratory Practice Guidelines. During the test, the test substance reacted with water. The main component of test substance gradually transformed into another substance, therefore the initial concentration of the test solution could not be kept steady. The measured concentration of test solution was expressed by the geometric mean concentration of the parent compound.

Under the conditions of the test, the 96h-LC50 of the test substance was greater than the geometric mean measured concentration of 100 mg/L substance solution.

Acute toxicity of Reactive Red F03-0318 on Daphnia magna was assessed in an Acute Immobilisation Test, over an exposure period of 48 hours in a semi-static test system. Based on the results of this study, the test item Reactive Red F03-0318 had no toxic effect on daphnids at up to at least 160 mg/L nominal.

The effect of Reactive Red F03-0318 test item was assessed on algal growth using the unicellular green alga Pseudokirchneriella subcapitata (Selenastrum capricornutum), over an exposure period of 72 hours. The results of this experiment showed that the majority of the observed inhibition effect was also related to the light absorption by the test item. At 50 and 100 mg/mL, a statistically significant effect was calculated for growth rates, however, this effect (inhibition: µ = 9.4% and 6.9%, respectively) is not biologically significant, but is due to the biological variability of the test system. A slight albeit not dose-dependent inhibition of yield was seen at 50, 100 and 200 mg/L, when the Test Item Reactive Red F03-0318 was in contact with the algae cells for 72 hours. This indicates that there was also a slight toxic effect on the growth of the alga (Pseudokirchneriella subcapitata). The 72h-EC50 was > 200 mg/L (nominal).

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.