Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
2.63 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 is 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 EC50 (growth rate) of 0.51 mg/L. Based on the available data the substance was classified and labelled as Aquatic Acute 1 (H400: Very toxic to aquatic life) and as Aquatic Chronic 3 (H412: Harmful to aquatic life with long lasting effects), according to Regulation 1272/2008/EC (CLP), as amended for the eigheenth time in Regulation (EU) 2022/692.