Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.087 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.872 mg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
5.65 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
65.226 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:
129.836 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

NEC freshwater sediment:

K_(susp-water) = 1.87E3 = 1870

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6  

PNEC_freshwater sediment = (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000

= (1870/1150)* 0.0872 *1000

= 141.7948 mg/kg wwt

= 652.256 mg/kg dwt  

 

PNEC marine water sediment:

K_(susp-water) = 1.87E3 = 1870

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6  

PNEC_marine water sediment = (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000

= (1870/1150)* 0.00872 * 1000

= 14.17948 mg/kg wwt

= 65.2256 mg/kg dwt  

 

PNEC soil:

K_(soil-water) = 2.24E3 = 2240

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13  

PNEC_soil = (K_(soil-water)/ RHO_(soil))*PNEC_water * 1000

= (2240/1700)* 0.0872 * 1000

= 114.8989 mg/kg wwt

= 129.8357 mg/kg dwt

 

Conclusion on classification

Acute aquatic toxicity:

Fish were the most sensitive species in acute aquatic toxicity tests with SIKA Hardener LI, according to EU method C.1 and OECD guideline 203, resulting in a 96-hour EC50 of 87.2 mg/L. Based on acute aquatic toxicity results obtained, SIKA Hardener LI was not classified and labelled for acute aquatic toxicity according to Directive 67/548/EC (DSD) and Regulation (EC) No 1272/2008 (CLP).

 

Chronic toxicity:

SIKA Hardener LI was tested in an aquatic toxicity test with algae, according EU-method C.3 and OECD guideline 201. The 72-hour EC50 for growth rate was 180.4 mg/L and the 72-hour NOEC 25 mg/L. SIKA Hardener LI was shown to be ready biodegradable failing the 10-day window and hydrolysis was rapid, with a half-life of 99 min at 25°C. Thus, the substance has to be classiffied with R52/53 according to Directive 67/548/EEC (DSD) and as environmental chronic toxic cat. 3 according to Regulation (EC) No 1272/2008 (CLP). This classification is in line with the data and the classification of both hydrolysis products (for details see IUCLID5 sections 6.1.1, 6.1.3 and 6.1.5).