Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
11.3 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

Additional information

Conclusion on classification

For the UGI products, no Acute 1/Chronic 1, 2, 3 classification category under CLP is warranted as there was no acute toxicity (<50%) to the alga (Pseudokirchneriella subcapitata), invertebrate (Daphnia magna) and fish (Danio rerio) in the WAF with 100 mg UGI/L. In addition, no chronic toxicity was observed based on the most sensitive species, the alga P.subcapitata. Indeed, the toxicity tests performed on the WAF with 1 mg UGI/L revealed an < 10% effect on growth rate for the alga. 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 level (WAF of 100 mg UGI/L) that is 100 times higher than the chronic threshold concentration level (WAF of 1 mg/L). This observation strongly suggests that no chronic effects below 1 mg/L are expected,
  • From the acute toxicity tests using a WAF of 100 mg UGI/L, it was noticed that the alga P. subcapitata was the most sensitive organism,
  • No significant chronic effects are noted for the most sensitive organism, i.e. the alga P. subcapitata, at a WAF concentration level of 1 mg UGI/L

Therefore, based on the ecotoxicity data that are presented in this report, there is no need for an environmental classification of UGI products.