Registration Dossier
Registration Dossier
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EC number: 236-050-7 | CAS number: 13122-18-4
Ecotoxicological Summary
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.
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