Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.343 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:
0.68 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
267 mg/kg food
Assessment factor:
30

Additional information

Aquatic PNECs

Fish, Daphnia and algal acute toxicity endpoints are available. From the available database, algae appear to be the most sensitive organisms. The algal inhibition test is a multi-generational study. Therefore, provided it is supported by a NOEC from another trophic level, the algal NOEC many be used as a chronic endpoint. In this case, additional chronic data are available forDaphnia magna (21-day NOEC of 0.12 mg/L). Thus, it is appropriate to apply an assessment factor of 50 to the NOEC from the algal inhibition study. Both growth and biomass endpoints were reported in the Weyers (2006) study. However ECHA guidance (CHAPTER R.7B - ENDPOINT SPECIFIC GUIDANCE page 48) indicates that growth endpoints are preferred. Therefore, it is appropriate to use the NOEC for growth of 0.11.

The following PNECs were calcuated using this endpoint:

PNEC Aqua (freshwater) - Based on an assessment factor of 50 the PNEC is 0.0022 mg/L.

PNEC sediment - No specific data are available for sediment-dwelling organisms. Using the Equilibrium Partitioning Method to estimate on the basis of the PNECwaterof 0.0022 mg/L, the resulting PNECsedimentis 3.43 mg/kgdwt. Partitioning is calculated using the Koc of 15560 for diphenyl cresyl phosphate, with the QSAR (MCI method).

PNEC marine sediment -No specific data are available for sediment-dwelling organisms. Using the Equilibrium Partitioning Method to estimate on the basis of the PNECmarine waterof 0.00022 mg/L, the resulting PNECsedimentis 0.343 mg/kgdwt. Partitioning is calculated using the Koc of 15560 for diphenyl cresyl phosphate, with the QSAR (MCI method).

PNEC terrestrial - No specific terrestrial data available. Using the Equilibrium Partitioning Method to estimate on the basis of the PNECwaterof 0.0022 mg/L, the resulting PNECterrestrialis 0.68 mg/kgdwt. Partitioning is calculated using the Koc of 15560 for diphenyl cresyl phosphate, with the QSAR (MCI method).

PNEC STP: Not derived as no effects were reported up to the limit of the water solubility.

The PNEC oral was calculated based on a 30 -day study in gallus domesticus (Kimmerle 1971). The NOAEL of 1000 mg/kg b.w. was multiplied with the conversion factor of 8 yielding a TOXoral of 8000 mg/kg. This value was divided by the assessment factor of 30 according to REACH guidance document R10.

Conclusion on classification

Based on available data the substance has to be classified as Aquatic Acute Cat. 1, H400 and Aquatic Chronic Cat. 3, H412 according to Regulation EC No. 1272/2008 and N, R50/53 according to Directive 67/548/EEC.