Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.33 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
10.42 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.33 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.491 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.09 g/kg food
Assessment factor:
90

Additional information

The PNEC´s were derived from the most sensitive study available for each compartment.

For calculation of the PNECwater the EC10 of 33.3 mg/L value of the Algal Growth Inhibition Test was used to reflect a worst case scenario. As three long term studies from three trophic levels were available, an assessment factor of 10 was applied (Guidance On Information Requirements And Chemical Safety Assessment, May 2008). Therefore, the PNEC for aquatic organisms is 3.33 mg/L.

PNECaquatic freshwater = lowest long term result/10 = 3.33 mg/L

For the calculation of the PNECaquatic-marine the lowest freshwater result, of the three long term studies from three trophic levels was used with an assessment factor of 100 (Guidance On Information Requirements And Chemical Safety Assessment, May 2008).

PNECaqua-marine = lowest long term result/100 = 0.33 mg/L

For the calculation of the PNECaqua-intermitted releases the most sensitive short term result was used and an assessment factor of 100 was applied. The short term toxicity test to fish revealed the most sensitive EC50 value of > 1042 mg/L.

PNECaqua-intermitted releases = lowest short term result/100 = 10.42 mg/L

Conclusion on classification

Based on the aquatic and terrestrial toxicity data obtained, that all coincide in the final conclusion that the test substance is of no immediate concern for the environment, BAYHIBIT AM is not classified according to EU Directive 67/548/EC and according to EU regulation No. 1272/2008 (GHS; amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006).

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