Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4.4 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
30 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.44 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.394 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.31 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Short-term toxicity tests for fish, invertebrates and algae are available for HHCB. The lowest toxicity value in these short-term tests is a 48h-EC50 of 0.3 mg/l for Daphnia magna. Therefore, based on the current data, HHCB needs to be classified as very toxic to aquatic life.

HHCB is not readily biodegradable and the experimentally determined BCF is >500, therefore it also needs to be classified as a long-term hazard to the environment.

For CLP, chronic toxicity data should be used for the classification of long-term hazards if available. Chronic toxicity tests are available for fish, invertebrates and algae. The lowest NOEC / EC10 in these chronic tests is a 6d-EC10 development of 0.044 mg/l for Acartia tonsa. Therefore, based on the available chronic data, HHCB also needs to be classified for its long-term hazard to the environment according to CLP.

According to Directive 67/548/EEC (DSD), the classification is R50/53. The classification according to Regulation 1272/2008/EC (CLP) is H400 and H410 (Aquatic Acute 1 and Aquatic Chronic 1).