Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.516 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.052 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
735 000 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
73 500 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:
259 000 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Official classification regarding environmental hazards

Aquatic compartment

There are no data in Regulation (EC) 1272/2008 Annex VI Table 3.1 and 3.2 for the substance available.

 

Self-classification

Aquatic compartment

Following DSD/DPD, the substance is not to be classified as hazardous for the environment.

Rationale:

According to DSD/DPD, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not readily degradable and have an experimentally determined BCF ≥ 100 (or, if absent, a log Kow ≥ 3.0), indicating a potential to bioaccumulate, which will be classified as R53 unless other scientific evidence exists showing classification to be unnecessary. DL-α-tocopherol (CAS 10191-41-0) is not readily degradable due to its poor solubility in water. However, the substance is not expected to accumulate significantly based on estimated BCF values and supporting information described in IUCLID Ch. 5.3.1. The substance is inherently and ultimately biodegradable after an extended period of time (see IUCLID Ch. 5.2.1). In addition, the available chronic toxicity data for fish and algae show the absence of chronic toxic effects up to the limit of solubility in water. Therefore, the substance is not to be classified as R53.

 

Following GHS, the substance is not to be classified as acutely hazardous to the aquatic environment. Based on the available acute and chronic data, the substance is not to be classified as chronically hazardous to the aquatic environment.

Rationale:

The substance is not to be classified as acutely hazardous to the aquatic environment, since the lowest acute effect value is > 1 mg/L. Acute toxicity was not observed up to the limit of water solubility.

 

Chronic data are available for fish and algae. According to Regulation (EC) No 1272/2008, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable in accordance with section 4.1.2.9.5 of the regulation and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4), indicating a potential to bioaccumulate, which will be classified as Chronic 4 unless other scientific evidence exists showing classification to be unnecessary. DL-α-tocopherol (CAS 10191-41-0) is not rapidly degradable due to its poor solubility in water. However, the substance is not expected to accumulate significantly based on estimated BCF values and supporting information described in IUCLID Ch. 5.3.1. The substance is inherently and ultimately biodegradable after an extended period of time (see IUCLID Ch. 5.2.1). In addition, the available chronic toxicity data for fish and algae show the absence of chronic toxic effects up to the limit of solubility in water. Therefore, the substance is not to be classified as Chronic 4.