Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.55 mg/L
Assessment factor:
20
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.06 mg/L
Assessment factor:
200
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.53 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:
5.3 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Where possible, PNEC calculations have been undertaken using default assessment factors in accordance with ECHA guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration] response for environment.

PNECs were derived from the study with the most sensitive species available for each compartment/endpoint. Acute aquatic effects tests with fish, daphnids and algae showed no significant effects and, in the case of fish and daphnids, LC50s were not established. Other than effects on algae, no long-term effects data are available on the substance itself. However, data are available on structural analogues of the substance and these have been used in deriving PNECs following adaptation of the NOECs to account for differences in molecular weight.

Conclusion on classification

Acute toxicity:

Algae are the most sensitive species to the toxic effects of 4 -MHHPA with an acute EC50 of 135 mg/L (based on growth rate). Based on the results obtained in the aquatic toxicity studies, 4 -MHHPA need not be classified regarding acute toxicity to the environment.

Although 4 -MHHPA is not regarded as being readily biodegradable, classification is not justified based on the low toxicity observed in acute studies at three trophic levels, and low potential for bioaccumulation.

Overview of Results used for Classification and Labelling:

Fish, short-term, freshwater: LC50 > 100 mg/L

Daphnia magna, short-term, freshwater: LC50 > 100 mg/L

Algae, freshwater: LC50 = 135 mg/L