Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.002 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.014 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:
0.028 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

A number of acute and chronic aquatic toxicity tests with the submission item are available. The available acute toxicity tests in species from three trophic levels showed that the substance exhibits acute toxicity to freshwater fish, daphnids and algae with algae being most sensitive and showing EC50 values in the range from 0.1 to 1 mg/L. In addition to the acute aquatic toxicity tests, a semi-static 21-day chronic exposure study on the reproductive toxicity of Gaskamine 240 to freshwater invertebrates (Daphnia magna) was conducted that gave a NOEC of 0.14 mg/L after 21 days of exposure. According to the ECHA guideline (Chapter R.10, ECHA 2008) a 72-hour study on the growth inhibition of freshwater green algae (Scenedesmus subspicatus) can be interpreted as a long-term study since it involves a number of reproductive cycles and thus several algal generations. The NOEC of 0.04 mg/L established in the algal study was lower than that found in the reproductive study with daphnids. The PNEC aqua (freshwater) thus was derived from the lower NOEC by applying an assessment factor of 50. Since marine toxicity studies are lacking, the PNEC aqua (marine water) was derived from the lower NOEC by applying an assessment factor of 500. Sediment and soil toxicity studies are not required for substances which are manufactured or imported in quantities ranging from 10 to 100 tonnes per year, and these study types therefore are lacking for Gaskamine 240. Preliminary PNECs for the sediment and soil compartments were calculated from the aquatic PNECs by using the equilibrium partitioning method and appropriate solids-water partition coefficients for suspended particulate matter (439 m3/m3) and soil (526 m3/m3). The Henry's Law constant at 25 °C used in the calculations was 1.73E-06 Pa x m3/mol (mean value based on a mean molecular weight of 292.4 g/mol). Gaskamine 240 has the potential to adsorb onto suspended particulate matter and soil particles and is to be considered as persistent in the environment. An additional assessment factor of 10 therefore was applied to calculate the PNECs for sediment and soil.

A reliable sewage sludge respiration inhibition studied showed that the substance exhibits toxicity to sewage sludge microorganisms at relatively low concentrations. The respiration rate of activated sludge was reduced by 50% at a nominal concentration of 70 mg/L after three hours of exposure. No effect was seen at a nominal test concentration of 10 mg/L after 3 hours of exposure.

The physicochemical properties of the substance tend to show that Gaskamine 240 has the potential to accumulate in food webs. A PNEC oral therefore was derived from the available data on oral repeated dose toxicity.

Conclusion on classification

On the basis of the available acute and long-term aquatic toxicity studies, the substance Gaskamine 240 has to be classified according to the second amendment of the CLP Regulation (Commission Regulation (EU) No 286/2011) into Category Acute 1 based on the findings of the acute algal toxicity test and into Category Chronic 2 based on the findings in the chronic toxicity test in aquatic invertebrates.