Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.25 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2.5 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.024 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.021 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:
260.04 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
6.67 mg/kg food
Assessment factor:
300

Additional information

Category approach and aquatic toxicity

The substance being Registered in this particular dossier is one of a series of chemically similar materials each of which is composed of a closely related series of alkylated phenol species. For further details on the Category, see section 13. The data for other members of the category can be used to complete the hazard characterisation for the Registration material where substance-specific data are lacking. The majority of aquatic testing is conducted using Water Accommodated Fractions or methods where the effects of the presence of refined base oil in some category member samples would be minimised. However, for the derivation of PNECs, the presence/absence of the highly refined base oil is taken into account; the Registration material does not comprise as a constituent the base oil, but all toxicology testing has been carried out with oil present, hence the end results and PNECs are adjusted to take account of this and end up with values relevant to the active ingredient of this Registration material.

Conclusion on classification

Based upon the results of the key studies for fish, aquatic invertebrates and algae the registered substance does not meet the criteria for acute aquatic toxicity classification according to 67/548/EEC or EC Regulation 1272/2008. As it shows no toxicity at the limits of solubility, does not readily biodegrade, and has only an in vitro/experimental BCF study value rather than a whole fish result, and no chronic NOECs, it is considered that the material should not be classified for the environment. Nevertheless, due to the missing information the substance is classified in a precautionary approach as H413.