Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.5 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
3.25 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.75 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1.57 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.1 g/kg food
Assessment factor:
30

Additional information

In accordance with ECHA guidance, PNECs were derived for benzyl butyl phthalate based on the available ecotoxicological data with the appropriate assessment factors applied considering the extent of the available data set.

Acute (LC50 and EC50) data were available at three tropic levels, invertebrates, algae and fish. The most sensitive result was for an algae. This EC50 value was used to derive the PNEC for intermittent releases in water.

Chronic (NOEC) data were available at three tropic levels, invertebrates, algae and fish. The most sensitive result was for a freshwater fish Pimephales promelas. This NOEC was used to derive the freshwater and marine water PNEC. As all these results were for freshwater species a higher assessment factor was applied to generate the marine water PNEC.

No applicable data on the toxicity of benzyl butyl phthalate in sediments or soils are available. Therefore the equilibrium partitioning method was applied to the freshwater PNEC to obtain the PNEC for freshwater sediments and soils, and to the marine waters PNEC to obtain the PNEC for marine sediments.

As no data were available for the toxicity of the substance to microorganisms the PNEC for STPs was determined from the concentration used in an inherent biodegradability test where no inhibition of the microorganisms was observed. This concentration was therefore considered as a NOEC. An assessment factor (10) was applied to generate the PNEC.

Conclusion on classification

Under Dir 67/548/butyl benzyl phthalate is classified as hazardous to the environment with the classification ‘R50/R53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment’ and has the symbol of ‘N : Dangerous for the environment’. Under the GHS/CLP butyl benzyl phthalate is classified as both ‘Aquatic Acute 1’ and ‘Aquatic Chronic 1'. 

The available ecotoxicological data agree with these assignments.