Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.016 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
8.31 mg/kg food
Assessment factor:
90

Additional information

PNEC water(freshwater)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (freshwater)

0.107 mg/L

1000

Based on the results of three short-term toxicity studies with freshwater aquatic organisms

 

The general principle of the method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008)is that the result from a laboratory test is divided by an appropriate assessment factor. PNECs are estimated by division of the lowest value for the toxicity with the relevant assessment factor. Results of long-term tests are preferred to those of short-term tests, because such results give a more realistic picture of effects on the organisms during their entire life cycle.

 

Short-term results from fish, daphnia and algae representing three trophic levels are available. The most critical result is the 48 hrs EC50 in daphnia of 107.3 mg/L, hence it seems appropriate in this assessment to consider 107.3 mg/L as the lowest end of the toxicity range for aquatic organisms. This range covers three taxonomic groups, fish, invertebrates and algae, and taking into account the recommendations of the ECHA guidance, a factor of 1000 to the lowest end of the short-term toxicity range is applied, obtaining a PNEC for aquatic organisms of 0.107 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/1000 = 0.107 mg/L

 

PNEC water (marine water)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (marine water)

0.0107 mg/L

10000

Based on the results of three short-term toxicity studies with freshwater aquatic organisms

 

The general principle of the method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008) is that the result from a laboratory test is divided by an appropriate assessment factor. PNECs are estimated by division of the lowest value for the toxicity with the relevant assessment factor. Results of long-term tests are preferred to those of short-term tests, because such results give a more realistic picture of effects on the organisms during their entire life cycle.

 

Short-term results from fish, daphnia and algae representing three trophic levels are available. The most critical result is the 48 hrs EC50 in daphnia of 107.3 mg/L, hence it seems appropriate in this assessment to consider 107.3 mg/L as the lowest end of the toxicity range for aquatic organisms. This range covers three taxonomic groups, fish, invertebrates and algae, and taking into account the recommendations of the ECHA guidance, a factor of 10000 to the lowest end of the short-term toxicity range is applied, obtaining a PNEC for aquatic organisms of 0.0107 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/10000 = 0.0107 mg/L


 

PNEC water (intermittent release)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (intermittent release)

1.07 mg/L

100

Based on the results of three short-term toxicity studies with freshwater aquatic organisms

 

The general principle given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008) is that the PNEC-values derived for freshwater or marine waters are based on the implicit assumption that the environmental exposure is constant. However, in many cases, discharges will be limited in time. In such cases, the environmental exposure will also be limited in time, and it is assumed that when exposure stops rapidly, populations can tolerate higher concentrations than when it is long lasting.

 

Short-term results from fish, daphnia and algae representing three trophic levels are available. The most critical result is the 48 hrs EC50 in daphnia of 107.3 mg/L, hence it seems appropriate in this assessment to consider 107.3 mg/L as the lowest end of the toxicity range for aquatic organisms. This range covers three taxonomic groups, fish, invertebrates and algae, and taking into account the recommendations of the ECHA guidance, a factor of 100 to the lowest end of the short-term toxicity range is applied, obtaining a PNEC for aquatic organisms of 1.07 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/100 = 1.07 mg/L

 

PNEC Sewage Treatment Plant (STP)

 

 

Value

Assessment factor

Remarks/Justification

PNEC Sewage Treatment Plant (STP)

2.0

10

Based on the results of a ready biodegradation test

 

The general principle of the method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008) is that the result from a laboratory test is divided by an appropriate assessment factor. PNECs are estimated by division of the lowest value for the toxicity with the relevant assessment factor.

 

The PNEC is derived from the available ready biodegradability test (OECD 301B). An assessment factor (AF) of 10 is applied to the test concentration of 20 mg/L at which the test item is not assumed to be inhibitory towards inoculum, obtaining a PNEC for microorganisms of 1.0 mg/L.

 

PNEC microorganisms = test concentration with no toxicity /10 = 2.0 mg/L

 

PNEC sediment (freshwater)

 

 

Value

Assessment factor

Remarks/Justification

PNEC sediment (freshwater)

0.40 mg/kg

Not applicable

Equilibrium partitioning

Chemical class for Koc – QSAR: Alcohols

Log Kow: <-1

 

An estimation of the PNEC sediment can be performed according to the equilibrium partitioning method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008):

 

PNEC sediment = (Ksusp-water / RHOsusp) * PNECwater * 1000

 

Where:

 

Ksusp-water = 0.932 m3 /m3 (according to EUSES2.1)

RHOsusp = 1150 kg/m3 (according to the “R16” Guidance document (2008) equation R16-23)

PNECwater [freshwater] = 0.107 mg/L

Conversion factor wet-dry suspended matter = 4.6

 

Hence:

PNECsediment wet = (0.932 / 1150) * 0.107 * 1000 = 0.087 mg/kg

PNECsediment dry = 0.0867 * 4.6 = 0.40 mg/kg

 

PNEC sediment (marine water)

 

 

Value

Assessment factor

Remarks/Justification

PNEC sediment (marine water)

0.040 mg/kg

Not applicable

Equilibrium partitioning

Chemical class for Koc – QSAR: Alcohols

Log Kow: <-1

 

An estimation of the PNEC sediment can be performed according to the equilibrium partitioning method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008):

 

PNEC sediment = (Ksusp-water / RHOsusp) * PNECwater * 1000

 

Where:

Ksusp-water = Ksusp-water = 0.932 m3 /m3 (according to EUSES2.1)

RHOsusp = 1150 kg/m3 (according to the “R16” Guidance document (2008) equation R16-23)

PNECwater [marine] = 0.0107 mg/L

Conversion factor wet-dry suspended matter = 4.6 (according to EUSES2.1)

 

 

Hence:

PNECsediment = (0.932 / 1150) * 0.0107 * 1000 = 0.0087 mg/kg

PNECsediment dry = 0.0087 * 4.6 = 0.040 mg/kg

 

 

PNEC soil

 

 

Value

Assessment factor

Remarks/Justification

PNEC soil

0.016 mg/kg

Not applicable

Equilibrium partitioning

Chemical class for Koc – QSAR: Alcohols

Log Kow: <-1

Water solubility: >10000 mg/L at 20 °C

Vapour pressure: 0.0068 Pa at 20°C

MW: 146.1 g/mol

 

An estimation of the PNECsoil can be performed according to the equilibrium partitioning method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008):

 

PNECsoil = (Ksoil-water / RHOsoil) * PNECwater * 1000

 

Where:

Ksoil-water = 0.239 m3 /m3 (according to EUSES2.1)

RHOsoil = 1700 kg/m3 (according to the “R16” Guidance document (2008) equation R16-23)

PNECwater [freshwater] = 0.107 mg/L

Conversion factor wet-dry soil = 1.13 (according to EUSES2.1)

 

Hence:

PNECsoil wet = (0.239 / 1700) * 0.107 * 1000 = 0.015 mg/kg

PNECsoil dry = 0.015 * 1.13 = 0.016 mg/kg

 

PNEC oral

 

 

Value

Assessment factor

Remarks/Justification

PNEC oral

8.31 mg/kg food

90

Based on the result of a sub-chronic study in mammals.

 

The general principle of the method given by the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008) is that the result from a laboratory test is divided by an appropriate assessment factor. PNECs are estimated by division of the lowest value for the toxicity with the relevant assessment factor. Results of long-term tests are preferred to those of short-term tests, because such results give a more realistic picture of effects on the organisms during their entire life cycle.

 

The most relevant data for derivation of the PNEC for secondary poisoning are from a 90 days study in the rat. The NOEC of 748 mg/kg bw/day is available.

 

According to Technical Guidance Document on Risk Assessment (2003) an assessment factor of 90 is appropriate for the results of a study of this duration. Therefore, applying this assessment factor:

 

PNECoral = NOEC/AF = 748/90 = 8.31 mg/kg food

Conclusion on classification

Aquatic Toxicity acute

The fish, daphnia, and algae acute aquatic toxicity are greater than 1 mg/L (96h LC50 (fish) > 119 mg/L, 48h EC50 (daphnia)

> 107.5 mg/L and 72h EC50 (algae) > 121.5 mg/L).

 As a result, the substance does not meet the criteria for acute classification according to Regulation (EC) No 1272/2008, Annex I section 4.1

 

Aquatic Toxicity chronic

The fish, daphnia, and algae acute aquatic toxicity are greater than 10 mg/l and lower than 100 mg/L (96h LC50 (fish) > 119 mg/L, 48h EC50 (daphnia) > 107.5 mg/L , and 72h ErC50 (algae) =51.4 mg/L)

As well, the substance is very soluble, ready biodegradable and has a Log Kow of -1.39. As a result, the substance does not meet the criteria for chronic classification according to Regulation (EC) No 1272/2008, Annex I section 4.1.