Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
10 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
15 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.184 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:
0.096 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The ecotoxicity assessment based on a weight-of-evidence approach considering studies for the registered UVCB mixture on acute aquatic toxicity to fish, Daphnia and algae as well as numerous ecotoxicity data for constituents of Tar acid, xylenol fraction, (CAS 84989-06-0). The acute aquatic toxicity data for fish, Daphnia and algae indicates that Tar acid, xylenol fraction (CAS 84989-06-0) is slightly less toxic than some of its constituents. In a weight-of-evidence approach all data were considered and the lowest effect value for each endpoint was chosen as key value for the chemical safety assessment. Thus, even in cases where less sensitive values would be available for Tar acids, Xylenol fraction itself, these values were not considered in favour to base the hazard assessment and classification on a worst case (e.g. see PNEC derivation above or conclusion on classification below).

Conclusion on classification

Classification related key information

Biodegradation in water: Not readily biodegradable

Bioaccumulation: low bioaccumulation potential based on log Kow <3

Aquatic acute toxicity

- Fish (freshwater): LC50 (96 h) = 4.4 mg/L (Salmo trutta) (read-across to p-cresol)

- Fish (marine): EC50 (96 h) = 3.7 mg/L (Gadus morrhua, eggs) (read-across to 2,4-xylenol)

- Aquatic invertebrates (freshwater): EC50 (48 h) = 2.37 mg/L (Daphnia magna) (read-across to 2,4-xylenol)

- Aquatic invertebrates (marine): EC50 (96 h) = 1.5 mg/L (Strongylocentrotus droebachiensis, eggs) (read-across to 2,6 -xylenol)

- Algae (freshwater): ErC50 (48 h) = 7.8 mg/L (Desmodesmus subspicatus) (read-across to p-cresol)

 

Aquatic chronic toxicity

- Fish (freshwater): NOEC (32 d) = 1.35 mg/L (Pimephales promelas) (read-across to p-cresol)

- Aquatic invertebrates (freshwater): NOEC (21 d) = 1.0 mg/L (Daphnia magna) (read-across to p-cresol)

- Algae (freshwater): NOEC (72 h) = 1.7 mg/L (Pseudokirchneriella subcapitata) (read-across to mixed xylenols)

Classification justification according to CLP

As a worst case assumption an analogue read-across approach considering the most toxic cosntituents was followed. Acute and chronic data on the toxicity of constituents of Tar acids, Xylenol fraction (CAS 84989-06-0) to aquatic organisms are available for all trophic levels. Tar acids, Xylenol fraction (CAS 84989-06-0) is considered to be not rapidly biodegradable and to have a low bioaccumulation potential (log Kow <3). The lowest acute aquatic toxicity value is 1.5 mg/L (EC50-96h, marin fish) and the lowest chronic toxicity value is 1 mg/L (NOEC-21d, water flea). Therefore, Tar acids, Xylenol fraction (CAS 84989-06-0) is classified and labelled as Category Chronic 2 for environmental hazards according to the consolidated version of Regulation (EC) No 1272/2008 (dated: 01.01.2017) and further amendments (ATPs).