Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.11 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.1 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
11 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.11 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
50.6 ng/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:
36.6 ng/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

A study report (rated as Klimisch 1) on aquatic invertebrates is available (Frenzl 1992). Daphnia magna were exposed for 48 hours to ortho-phthalaldehyde in a static short-term GLP toxicity study (EU C.2) to concentrations of 0.05, 0.07, 0.20, 0.50, and 0.94 mg ortho-phthalaldehyde/L for 48 hours. The determined EC50 after 48 hours is 0.11 mg/L (95% CI 0.13 -0.10).

In a CO2 Evolution (Modified Sturm Test) Test according to OECD 301 B and GLP the biodegradation of ortho-phthalaldehyde was studied (Weiss-Fuchs 2002). The test substance is not readily biodegradable under test conditions as the biodegradation reached only 7 % after 28 days.

Data on the freshwater algae Pseudokirchneriella subcapitata as presented on the EPA database (ECOTOX knowlegdebase) is added to the dossier as supplementary information. The reported 96-h EC50 is 184 µg/L, indicating that D. magna is slightly more sensitive than algae.

An additional growth inhibition study with aquatic plants (algae preferred) is not necessary in the present dossier, as the short-term toxicity testing on D. magna and the test on biodegradation showed that the most rigorous classification is necessary for the test item. Therefore, further testing would not contribute to additional benefit of scientific knowledge.

Conclusion on classification

Results from the acute toxicty testing show that ortho-phthalaldehyde must be classified as Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) following the provisions laid down in the CLP Regulation (Regulation (EC) No 1272/2008), because the EC50 values reported are < 1 mg/L and the substance is not readily biodegradable.