Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.3 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.03 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
20 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.065 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.006 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:
0.009 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33.3 mg/kg food
Assessment factor:
300

Additional information

Acute toxicity studies were performed to assess the acute toxicity of Reactive Blue 19 or its structural analogues to Leuciscus idus melanotus or Danio rerio under static conditions.

Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. All results are expressed in terms of nominal concentrations. No toxic effects against fish were observed at the limit test concentration of 100 mg/L defined by the OECD Guideline. The LC50 was calculated to lie above 300 mg/L.

Acute toxicity on Daphnia magna was assessed in an Acute Immobilisation Test with a structural analogue, over an exposure period of 24 hours. Based on the results of this study, the test item had no toxic effect on daphnids at up to 900 mg/L nominal.

The effect of the test item was assessed on algal growth using the unicellular green alga Scenedesmus subspicatus (new name: Desmodesmus subspicatus), over an exposure period of 72 hours in a test system adapted to dyestuff testing, to take into account the UV-absorbing properties of the stained tes medium. The test results of this study showed, that the effects observed were soely due to UV-absorption; no toxic effects were observed on algae growth up to the highest test substance concentration of 320 mg/L.

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 according to GLP and/or 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.