Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.127 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.61 mg/L

Marine water

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

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:
1 000 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
100 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
100 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

No ecotoxicological information is available for synthetic rutile. Therefore, read-across is proposed to TiO2 and upgraded ilmenite (UGI).

For synthetic rutile, no Acute 1/Chronic 1, 2, 3 classification category under CLP is warranted as there was no acute toxicity (<50%) observed on invertebrates and fish up to >1,000 mg TiO2/L. Only algae resulted in an EC50 value for growth rate below 100 mg/L (61 mg TiO2/L) for Pseudokirchneriella subcapitata. However, the corresponding chronic EC10 values for the algae P. subcapitata was 12.7 mg TiO2/L, which is above the 1 mg/L threshold for classification based on chronic toxicity. Although no chronic data are available for daphnids and fish, the remaining Chronic 4 classification category under CLP can be removed based on the following arguments:

• No significant acute toxicity was noted for daphnids and fish at a concentration of 100 mg/L that is 100 times higher than the chronic threshold concentration level (1 mg/L). This observation strongly suggests that no chronic effects below 1 mg/L are expected for fish and invertebrates.

• No significant chronic effects are noted for the most sensitive organism, i.e. the alga P. subcapitata, at a concentration of 1 mg/L.

Therefore, there is no need for an environmental classification of synthetic rutile.