Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.003 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.005 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.05 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:
0.098 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

PNEC freshwater sediment:


K_(susp-water) = 49.7


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


 


PNEC_freshwater sediment


= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000


= (49.7/1150)* 2.5E-03 *1000


= 0.108 mg/kg wwt


= 0.497 mg/kg dw


 


PNEC marine water sediment:


K_(susp-water) = 49.7


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


 


PNEC_marine water sediment


= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000


= (49.7/1150)*2.5E-04*1000


= 0.0108 mg/kg wwt


= 0.0497 mg/kg dw


 


PNEC soil:


K_(soil-water) = 58.7


RHO_(soil) = 1700


Conversion factor (wwt -> dwt): 1.13


 


PNEC_soil


= (K_(soil-water)/ RHO_(soil))*PNEC_water * 1000


= (58.7/1700)* 2.5E-03* 1000


= 8.63E-02 mg/kg wwt


= 0.0975 mg/kg dw

Conclusion on classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


 


The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Tert-Butylperoxy-3,5,5-trimethylhexanoat was not readily biodegradable. Algae were the most sensitive species tested, revealing a 72 h NOEC (growth rate) of 0.125 mg/L and a 72 h EC 50 (growth rate) of 0.51 mg/L. No long-term toxicity study was available. Based on available data the substance was classified and labelled as Aquatic Chronic 1; (H410: Very toxic to aquatic life with long lasting effects) according to Regulation 1272/2008/EC (CLP), as amended for the seventeenth time in Regulation (EU) 2021/849.