Registration Dossier

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):
21 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:
0.012 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.005 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

Read-across from other, structurally closely related ZDDPs is justified because of structural similarity and analogy of properties and effects.

Conclusion on classification

Studies of this substance and/or structurally similar ZDDPs are available for evaluating biodegradation and toxicity to aquatic vertebrate and invertebrate species.

 

This substance and/or structurally similar ZDDPs are

not biodegradable when tested in accordance with OECD 301D. The biological oxygen demand was <5% of the chemical oxygen demand in both test concentrations at all sampling dates.

The acute aquatic toxicity of this substance and/or structurally similar ZDDPs

was evaluated using rainbow trout and was conducted in accordance withOECD 203. The 96 h LL (Lethal Loading Rate) 50 value of the substance was determined to be 4.4 mg/l. The No Observed Effect Loading rate was 3.2 mg/l loading rate WAF.

 

Then acute toxicity of this substance and/or structurally similar ZDDPs

also was evaluated in Daphnia (OECD 202). The 48-Hour EL*50 was determined to be 75 mg/L nominal loading rate and the No Observed Effect Loading rate was 32 mg/l nominal loading rate.

 

The acute toxicity of this substance and/or structurally similar ZDDPs

was evaluated in freshwater algae in accordance with OECD Guideline 201. Exposure ofScenedesmus subspicatusto the test material gave an EbL50 (72h) value of 240 mg/L loading rate WAF and an ErL50 (0-72hr) value of 410 mg/L loading rate WAF. The No Observed Effect Loading rate was 220 mg/L loading rate WAF.

 

Based on the available environmental fate and ecotoxicological data for daphnids, fish and algae, this substance requires classification to the aquatic environment according to Directive 67/548/EEC,  the EU CLP (Regulation (EC) No. 1272/2008).  This substance has acute aquatic toxicity between 1-10mg/L in the most sensitive species, is not readily biodegradable, and has an estimated log P =3.0.