Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
64 ng/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.64 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
6.4 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
64 ng/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
24.3 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:
48.6 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

The environmental classification of 2,2'-(2-methylpropylidene)bis[4,6-xylenol] is currently not harmonized according to the CLP Regulation (EC) 1272/2008.

Short-term toxicity tests resulted in EC50 values below 1 mg/L for both fish (96-h LC50 = 0.064 mg/L), daphnids (48-h EC50 = 0.19 mg/L) and Pseudokirchneriella subcapitata (72-h EC50 0.067 mg/L), to which it should be noted that no effects were observed at the limit of solubility in the media.

Long-term studies are not available. Based on these results and due to the fact 2,2'-(2-methylpropylidene)bis[4,6-xylenol] is not readily biodegradable, highly insoluble in water this substance should be classified in Acute Category 1 and Chronic Category 1 for the aquatic environment according to Annex 1 (section 4.1.2.6) of the CLP Regulation.