Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.079 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:
0.149 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

PNEC water(freshwater)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (freshwater)

0.0144 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 96 hrs LC50 in Rainbow trout of 14.4 mg/L, hence it seems appropriate in this assessment to consider 14.4 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 0.0144 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/1000 = 0.0144mg/L

 

PNEC water (marine water)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (marine water)

0.00144 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 96 hrs LC50 in Rainbow trout of 14.4 mg/L, hence it seems appropriate in this assessment to consider 14.4 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 0.00144 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/10000 = 0.00144 mg/L


 

PNEC water (intermittent release)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (intermittent release)

0.144 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 96 hrs LC50 in Rainbow trout of 14.4 mg/L, hence it seems appropriate in this assessment to consider 14.4 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 0.144 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/100 = 0.144 mg/L

 

PNEC Sewage Treatment Plant (STP)

 

 

Value

Assessment factor

Remarks/Justification

PNEC Sewage Treatment Plant (STP)

2.7 mg/L

100

Based on the results of a Activated Sludge Respiration Inhibition 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 Activated Sludge Respiration Inhibition Test (OECD 209). An assessment factor (AF) of 100 is applied to the 3hrs EC50 result of 270 mg/L, obtaining a PNEC for microorganisms of 2.7 mg/L.

 

PNEC microorganisms = test concentration with no toxicity /100 = 2.7 mg/L

 

PNEC sediment (freshwater)

 

 

Value

Assessment factor

Remarks/Justification

PNEC sediment (freshwater)

0.786 mg/kg

Not applicable

Equilibrium partitioning

 

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 = 13.65 m3 /m3

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

PNECwater [freshwater] = 0.0144 mg/L

Conversion factor wet-dry suspended matter = 4.6

 

Hence:

PNECsediment wet = (13.65 / 1150) * 0.0144 * 1000 = 0.1709 mg/kg

PNECsediment dry = 0.1709 * 4.6 = 0.786 mg/kg

 

PNEC sediment (marine water)

 

 

Value

Assessment factor

Remarks/Justification

PNEC sediment (marine water)

0.079 mg/kg

Not applicable

Equilibrium partitioning

Chemical class for Koc – QSAR: Non-hydrophobics

Log Kow: 2.94

 

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 = 13.65 m3 /m3

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

PNECwater [marine] = 0.00144 mg/L

Conversion factor wet-dry suspended matter = 4.6

 

Hence:

PNECsediment = (13.65 / 1150) * 0.00144 * 1000 = 0.017 mg/kg

PNECsediment dry = 0.017 * 4.6 = 0.079 mg/kg

 

 

PNEC soil

 

 

Value

Assessment factor

Remarks/Justification

PNEC soil

0.149 mg/kg

Not applicable

Equilibrium partitioning

 

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 = 15.5 m3 /m3

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

PNECwater [freshwater] = 0.0144 mg/L

Conversion factor wet-dry soil = 1.134

 

Hence:

PNECsoil wet = (15.5 / 1700) * 0.0144 * 1000 = 0.131 mg/kg

PNECsoil dry = 0.131 * 1.134 = 0.149 mg/kg

 

PNEC oral

 

 

Value

Assessment factor

Remarks/Justification

PNEC oral

5.0 mg/kg food

300

Based on the result of a sub-acute 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 28 days study in the rat. The NOAEL of 150 mg/kg bw/day is available, hence it seems appropriate in this assessment to consider 150 mg/kg bw/day as the lowest end of the toxicity range for oral exposure.

 

According to the ECHA guidance on information requirements and chemical safety assessment, Chapter R.10 (May 2008):

-         An appropriate conversion factor should be use for converting results expressed as NOAEL to NOEC;

-         An appropriate assessment factor should be used for calculating PNECoral from the calculated NOEC.

 

It is determinate that a conversion factor from NOAEL to NOEC of 10 should be applied and an assessment factor of 300 is appropriate for this kind of study, hence:

 

NOEC = NOAEL * CONV = 150 * 10 = 1500 mg/kg food

PNECoral = NOEC / AF = 1500 / 300 = 5.0 mg/kg food

Conclusion on classification

Hazard to the aquatic environment: Substance has no adequate chronic toxicity data on aquatic organisms, while it has adequate acute toxicity data on aquatic organisms. The following results are taken into consideration for Classification and Labeling assessment:

- LC50 (Rainbow trout, 96h, OECD 203): 14.4 mg/L

- EC50 (daphnia magna, 48h, OECD202): 27.2 mg/L

- ErC50 (Selenastrum Capricornutum, 72h, OECD201): 26.6 mg/L

- Ready Biodegradability (28 days, OECD301B): not readily biodegradable

- BCF: no data available

- LogKow (OECD117): 2.94 at 21°C

 

As a result, the substance meets the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 4.1 as amended by Regulation (EC) No 286/2011, as follow:

- Aquatic Chronic 3

- no pictogram is used

- no signal word is used

- Hazard Statement: H412, Harmful to aquatic life with long lasting effects