Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
37.2 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
186 µg/L

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1 897 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
189.7 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
357.6 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Additional information

Aquatic Toxicity: The substance is not classified as a « difficult test substance » according to the OECD Guidance document on aquatic toxicity testing of difficult substances and mixtures (OECD series on testing and assessment n° 23). The substance has been shown to be moderately soluble (561 mg/l at 20°C), not volatile (Vapor pressure < 0.01hPa, Henry’s law constant H < 0.01 Pa m3/mol), non-ionisable and stable in the aquatic tests conditions (t1/2 pH4 and pH 7 > 1 year, t1/2 pH9 = 7.8 days). Furthermore the low octanol/water partition coefficient (log Pow < 3.0) indicates that loss due to partitioning (adsorption to the test equipment or to the test organisms) is not significant and that there is no bioaccumulation concerns.

 

In the table below are summarized the results of aquatic toxicity studies performed:

Test guideline

 

Median lethal dose (mg/l)

NOEC (72h) (mg/l)

Fish Acute toxicity (OECD 203)

LC50 (96h)

18.2

Short term Toxicity to Daphnia (OECD 202)

EC50 (48h)

8.25

Algal Growth Inhibition Test (OECD 201)

ErC50 (72h)

45.9

11.7

 

Median lethal dose (mg/l)

EC10 (21 days)* (mg/l)

Daphnia magna reproduction Test (OECD 211)

EC50 (48h)

16.1

1.86 (reproduction)

2.01 (mortality)

* See attached report "Hedione _Chronic toxicity study to Daphnia magna_final_10032014.pdf" 

Microorganism Toxicity: No toxicity concerns towards microorganisms were observed in the toxicity control of the ready biodegradation experiments in which the substance is readily biodegradable at more than 90%.

As the substance is ready biodegradable, its Log Pow is < 3, it is therefore not classified as hazardous to the aquatic environment according to DSD (67/548/CEE) and CLP (1272/2008/CEE).

 

Sediment Toxicity: No sediment testing is necessary if the log Pow < 3 (Figure R7.8-9: ITS for toxicity to sediment organisms, pages 136). Relevance to perform this test will be assessed in the Chemical Safety Assessment.

 

Terrestrial organism Toxicity: Relevance to perform this test will be assessed in the Chemical Safety Assessment.

Conclusion on classification

As all acute toxicity environmental tests performed (Fish, Daphnia, Algae) have a LC50 > 1 mg/l, the lowest acute effect being 8.25 mg/L, there is no short term aquatic hazard. As the substance is readily biodegradable, and the EC10 is >1 mg/L, there is no long term aquatic hazard. The substance is therefore not classified as hazardous to the aquatic environment according to DSD (67/548/CEE) and CLP (1272/2008/CEE).