Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.97 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
19.7 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.197 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1.97 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.008 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

For the acute aquatic toxicity classification, the results of the ready biodegradation test and the results of short-term toxicity tests for the source substance Direct Red 83:1 are taken into account. In this casethe result of the short-term toxicity test to algae is considered to be the worst case witha 72 h-ErC50 of 2.81 mg/L (for the test substance with a purity of 69.96 %) and a 72 h-ErC50 of 1.97 mg/L (for the test substance with a purity of 100 %).In addition, the test substance is considered to be not readily biodegradable. 

For the chronic aquatic toxicity classification, the results of the ready biodegradation test, the results of the short-term toxicity and the results of the long-term toxicity are taken into account for the source substance Direct Red 83:1. In this case there are adequate toxicity data for one trophic level (algae). The result of the short-term toxicity test to algae is considered to be the worst case with a 72 h-ErC50 of 2.81 mg/L (for the test substance with a purity of 69.96 %) and a 72 h-ErC50 of 1.97 mg/L (for the test substance with purity of 100 %) and a 72 h-ErC10 of 0.54 mg/L (for the test substance with a purity of 69.96 %) and a 72 h-ErC10 of 0.38 mg/L (for the test substance with a purity of 100 %).

Based on these results the substance the source substance Direct Red 83:1 is not classified as acute aquatic toxicity and based on these results the substance is classified as chronic aquatic toxicity Cat. 2; H411:Toxic to aquatic life with long lasting effects according to Regulation (EC) No 1272/2008 (CLP) as amended for the fourteenth time in Regulation (EU) 2020/217.Based on the read-across characteristics explained in the previous chapters, it is justified that the target substance Direct Red 243 acquires also this classification.