Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
9.96 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:
47.69 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
8.33 mg/kg food
Assessment factor:
30

Additional information

Long term toxicity to fish study according to GLP-standards and OECD guideline 210. The NOEC of BHT in Oryzias latipes was 0.053 mg/L and the LOEC was 0.14 mg/L.

Long term toxicity to aquatic invertebrates according to OECD guideline 211 and GLP standards. The 21 -day NOEC of BHT in Daphnia Magna was 0.069 mg/L and the 21 -day EC50 was 0.096 mg/L.

Conclusion on classification

Based on the available ecotoxicological information:

Short-term toxicity to fish: The estimated 96-h LC50 for fish is 0.199 mg/l (ECOSAR v1.00a, phenols class).

Short-term toxicity to aquatic invertebrates: The 48-Hour EC50 based on the geometric mean measured test concentrations was 0.48 mg/L with 95% confidence limits of 0.39 - 0.70 mg/L and the No Observed Effect Concentration was 0.15 mg/L.

Toxicity to aquatic algae: The estimated 96-h EC50 for green algae is 0.758 mg/l (ECOSAR v1.00a, phenols class).

Since the values are below 1 mg/L and the substance is considered as not readily biodegradable and has a log Pow greater than 4, the substance is classified as follows:

Hazardous to the aquatic environment, Chronic Hazard Category 1 and Acute Hazard Category 1 (M-factor 1).