Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
15 000 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.233 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:
0.303 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

According to Annex I of Directive 67/548/EEC and Annex VI of Regulation (EC) No 1272/2008, there is no environmental classification for diisopropanolamine. The acute toxicity to fish, daphnids and algae are > 100 mg/L. In brief for fish the LC50 after 96 hours of exposure was 1466 mg/L, for daphnids the EC50 was 272 mg/L after 48 hours of exposure, for algae the ErC50 after 72 hours of exposure was 339 mg/L. Relevant chronic toxicity data are not available. There is a single long-term reproduction study for which only a summary is availabe and no NOEC on reproduction was reported. However the LOEC was 16 mg/L after 7 days of exposure based on survival. For algae, the NOEC based on the growth rate after 72 hours of exposure was 125 mg/L. Both values do not indicate the need for chronic classification. Diisopropanolamine has a measured low log Kow of -0.79 and is hence not expected to bioaccumulate. Further, the substance is readily biodegradable. Thus, environmental classification of diisopropanolamine for acute or chronic aquatic hazards is not indicated.

Conclusion on classification

Official classification regarding environmental hazards

Aquatic compartment

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is not officially classified.

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is not officially classified.

  

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 (72-h ErC50 = 240 mg/L; S. costatum; Eide-Haugmo 2009/2012).

Chronic data are available only for algae, therefore classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data:

Chronic data are available only for algae (72h ErC10 = 219 mg/L) indicating that the substance does not present a long-term hazard according to the categories outlined in Table 4.1.0(b) (ii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) for rapidly degradable substances.

- Acute toxicity data:

Daphnids and Fish are the trophic levels not covered by chronic data. Therefore, classification is based on the respective acute effect data. The lowest acute effect value is a 48-h EC50 of 277.7 mg/L determined for daphnia; the substance is rapidly degradable and the log Pow is < 4. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is not to be classified as chronically hazardous.