Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.02 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.602 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.013 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:
0.003 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

Dibenzoyl peroxide has a Log Kow of 3.2 (OECD 117) indicating a low potential for bioaccumulation. The substance is classified as readily biodegradable.

The acute aquatic toxicity data (C(E)L50) based on the lowest of the available toxicity values is between 0.01 and 0.1 mg/L.

Tow long-term aquatic toxicity dataare available for two trophic levels: algae and invertebrates. The lowest long-term toxic data corresponds to EC10 of 0.001 mg/L(from OECD 211).

The aquatic hazard classification based on these data according to CLP criteria (Regulation No 1272/2008) is:

Category Acute 1, M-factor = 10

Category Chronic 1, M-factor = 10

One key study is available for each of the following endpoints:

Acute toxicity to Daphnia magna

  

Initial mean measured Dibenzoyl peroxide (mg/L)

EC50 (48 h)

0.110 [0.0765, 0.157]

No observed effect concentration (NOEC)

0.0765

 [95% confidence limits]

 

Algal growth inhibition assay

  

Initial measured Dibenzoyl peroxide (mg/L)

Area under the growth curve

  

EbC50(72 h)

0.0422 [0.0230, 0.0661]

No observed effect concentration (NOEC)

0.02

Average specific growth rate

  

ErC50 (0 - 72 h)

0.0711 [0.0643, 0.0729]

No observed effect concentration (NOEC)

0.02

Yield

  

EyC50 (0 - 72 h)

0.0613 [0.0248, 0.0687]

No observed effect concentration (NOEC)

0.02

 [95% confidence limits]

Acute toxicity to fish

  

Initial mean measured Dibenzoyl peroxide (mg/L)

EC50 (96 h)

0.0602 [0.0477, 0.0856]

No observed effect concentration (NOEC)

0.0316

[95% confidence limits]

Chronic toxicity to invertebrates

  

Mean measured Dibenzoyl peroxide (mg/L)

EC10 (21d) reproduction

0.001 [0.0001, 0.0018]

  

No observed effect concentration (NOEC)

  

0.0011

[95% confidence limits]