Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
45 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.007 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:
0.01 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10.67 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Studies of this substance are available for evaluating biodegradation, metabolism, and toxicity to aquatic vertebrate and invertebrate species.

 

An analog of this substance, EC 283-392-8, was not ready biodegradable when tested in accordance with OECD Guideline 301B (Schaefer, EC and Haberlein, D, 1998). The mean percent theoretical CO2 evolved for the test substance was 1.5% (range 0.6 to 2.0%). The control chambers evolved an average of 6.5 milligrams of CO2 over the test period. The mean percent theoretical CO2 evolved for the reference substances was 99%.

 

This substance caused a significant adverse effect on the oxygen consumption of the microbes associated with the activated sludge (Goodrich, MS, 1994; OECD Guideline 209). The EC50for inhibition of metabolism, as represented by respiration, was calculated to be greater than 10,000 mg/l. . 

 

The acute aquatic toxicity of an analog ofthis substance, EC 283-392-8,was evaluated using rainbow trout and was conducted in accordance withOECD Guideline 203 (Goodband, TJ, 2001). The 96 h LL (Lethal Loading Rate) 50 value of the substance was determined to be 4.5 mg/l. The NOEL was 1.8 mg/l. The 96 h LC50 and NOEL values for an analog of this substance with the saltwater speciesCyprinodon variegataswas determined to be 46 mg/l and less than 26 mg/l, respectively. 

 

Then acute toxicity of an analog of this substance, EC 283-392-8,also was evaluated inDaphnia(Goodband, TJ, 2005; OECD Guideline 202). The 48-Hour EL*50 was determined to be 23 mg/L nominal loading rate and the No Observed Effect Loading rate was 10 mg/l nominal loading rate.

 

The acute toxicity of an analog of this substance, EC 283-392-8,was evaluated in freshwater algae in accordance with OECD Guideline 201 (Vryenhoef, H, 2005). Exposure ofScenedesmus subspicatusto the test material gave an EbL50 (72h) value of 21 mg/L loading rate WAF and an ErL50 (0-72hr) value of 24 mg/L loading rate WAF. The No Observed Effect Loading rate was 10 mg/L loading rate WAF.

 

Based on the available environmental fate and ecotoxicological data for daphnids, fish and algae, this substance has acute aquatic toxicity between 1-10mg/L in the most sensitive species, is not readily biodegradable, and has a measured log Kow of 2.21. Therefore, this substance is classifiable to the aquatic environment ( Aquatic Chronic Category 2a) ccording to the EU CLP (Regulation (EC) No. 1272/2008).  

 

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