Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.034 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.335 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.335 mg/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:
0.34 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.034 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:
0.048 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNECs have been included in the REACH registration for completeness. No exposure assessment has been conducted as the substance is not present in concentrations which would lead to polymers being classified as hazardous under the CLP regulation.  No performance of the exposure assessmnet is further supported with 3 documents attached in Section 13.2 of this REACH registration.   

Conclusion on classification

No effects were observed at a concentration of 89.2 mg/L in Daphnia magna. As this is based on data provided by ECHA, full details on this value are not available although this is possibly the highest concentration tested. In Algae a 72 hr NOEC of 69.98 mg/L is provided, again with no indications why higher values were not tested. In an acute toxicity study to fish a 96 hr LC50 of 33.5 mg/L is available, which is the key value for safety assessment as fish appear to be the most sensitive trophic level. Based on this value, no classification in accordance with the CLP regulation (1272/2008, as amended) is relevant for this substance in relation to aquatic acute toxicity. When considering Chronic toxicity, the only available result is an algae study NOEC of 69.98 mg/L. As the substance is not readily biodegradable (not fulfilling 10 -day window criterion), consideration of the acute data is applicable in this case. As the lowest acute LC/EC50 value is > 10 and < 100 mg/L (fish), classification as Aquatic Chronic. 3 is deemed appropriate for this substance.