Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.73 µg/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:
2.77 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Adequate chronic toxicity data are not available for Basic Blue 140, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available.

The key values chosen for Chemical Safety Assessment concerning the aquatic compartment are the following:

- for the short-term toxicity to fish (Danio rerio) the effect level was recorded in the range of 10 and 100 mg/l (LC50 (96 h): 18.2 mg/l)

- for short-term toxicity to aquatic invertebrates (Daphnia magna) the EC50 (48h) resulted to be greater than 100 mg/l

- for toxicity to aquatic algae and cyanobacteria (Scenedesmus subspicatus) the EC50 (72h) resulted to be greater than 100 mg/l

- for toxicity to microorganisms the EC10 (3h) was stated at 580 mg/l and the EC50 resulted greater than 1000 mg/l

The outcomes from the short-term tests performed on the three trophic levels suggest that fish is the most sensitive species.

In order to derive the PNEC water (both freshwater and marine water), the short-term effect level of the most sensitive species has been chosen. The PNEC for STP has been derived taking into account the EC10 value resulted from the respiration inhibition test on microorganisms.

Conclusion on classification

Adequate chronic toxicity data are not available; Basic Blue 140 (BBl140) is very water soluble, not readily biodegradable and has a negative log kow.

On the basis of the short-term toxicity data on the three trophic levels (details above), BBl140 can be classified as hazard to the aquatic environment in category 3 (H412), according to the CLP Regulation (EC 1272/2008).