Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.4 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
18.3 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
19.3 µg/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:
18.7 µg/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

Available data: the acute and chronic data are as follows.

Fish acute data: 96h-LC50: > 102 mg/L (norminal)

Daphnia:

Acute data: 48h-EC50: 18.3 mg/L (norminal);

Chronic data: 21 d NOEC: 1.7 mg/L (norminal)

Algae growth inhibition data: 72h-ErC50 value (growth rate): 316 mg/L (norminal); 72h No-Observed Effect Concentration (NOEC): < 25 mg/L (norminal)

And the substance is considered to be readily degradable and log Pow at pH 4, 7 and 10 were less than 1.

 

Due to the test substance can react with rater rapidly generating lots of hydrolysis products, the toxicity is considered as caused by whole muti-components in solution, hence the classification is based on nominal concentration of test substance.  

Acute classification:

In according to Regulation (EC) 1272/2008, amendment 286/2011, table 4.1.0 (a), acute classification is either Category Acute 1 or not classified, Category Acute 1 applies if EC50 for fish or Daphnia magna or algae ≤ 1 mg/L.

For this substance all EC50 values are > 1mg/L, therefore the substance is not classified for acute aquatic toxicity.

 

Chronic classification:

In according to Regulation (EC) 1272/2008, amendment 286/2011, table 4.1.0 (b.ⅱ), rapidly degradable substances for which there are adequate chronic toxicity data available, chronic classification is either Category Chronic 1, Category Chronic 2, Category Chronic 3 or not classified.

As the substance is considered to be readily degradable, chronic 21 d EC50/NOEC values for Daphnia were all > 1 mg/L, Category Chronic 1, 2 and 3 do not apply (Category Chronic 3 is required for rapidly degradable substances if chronic NOEC or ECx for fish or Daphnia magna or algae > 0.1 to ≤ 1 mg/L).

In addition, “Safety net” classification (Category Chronic 4) are cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow ≥ 4). This substance does not meet this criteria.

Therefore the substance is not classified for chronic aquatic toxicity.

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