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:
100 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.086 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 air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.002 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
111.11 mg/kg food
Assessment factor:
90

Additional information

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

General discussion

The acute toxicity studies in Fish and Daphnia produced no adverse results, with respective EC50 / LC50 values presented as limits at > 100 mg/l (the limit of the test concentrations measured).  The substance is not considered to be environmentally dangerous on this basis.

The original algae study conducted yielded the following results: 

72 h EC50 growth rate 190 mg/L

72 h EC50 biomass 32 mg/L

72 h NOEC 9.4 mg/L

Based on the effects noted, it was assumed that the results may be due to algistatic effects of the dyestuff, rather than actual toxicity observed. A further assessment of this endpoint was therefore conducted to assess the effects of light absorption. This investigation indicated that effects noted in the original algal study were due to light absorption rather than associated toxicity. On this basis the substance is not deemed to be toxic to algae. No classification and labelling is applicable. This was agreed by the German Member State Authority in the original notification of the substance under the 7thAmendment.

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

Conclusion on classification

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