Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC water(freshwater)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (freshwater)

0.973 mg/L

1000

Based on the results of short-term toxicity studies with 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 on the read-across substances Sorbitol and Maltitol. The most critical short-term result is the 48 hour EC50 in aquatic invertebrates of > 973 mg/L. Therefore, it seems appropriate in this assessment to consider 973 mg/L as the lowest end of the short-term 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 0.973 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/1000 = 0.973 mg/L

 

PNEC water (marine water)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (marine water)

0.0973 mg/L

10000

Based on the results of short-term toxicity studies with 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.

 

The data set does not include test data on marine water species but short-term results on freshwater species representing three trophic levels (fish, daphnia and algae) are available on the read-across substances Sorbitol and Maltitol. Therefore, in absence of data on saltwater species the PNEC for aquatic organisms can be used for both, freshwater and marine environments and divided by the appropriate assessment factor. The most critical short-term result is the 48 hour EC50 in aquatic invertebrates of > 973 mg/L. Therefore, it is appropriate to consider 973 mg/L as the lowest end of the short-term 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 used, obtaining a PNEC for aquatic organisms of 0.0973 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/10000 = 0.0973 mg/L

 

PNEC water (intermittent release)

 

 

Value

Assessment factor

Remarks/Justification

PNEC water (intermittent release)

9.73 mg/L

100

Based on the results of short-term toxicity studies with 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 on the read-across substances Sorbitol and Maltitol. The most critical short-term result is the 48 hour EC50 in aquatic invertebrates of > 973 mg/L. Therefore, it seems appropriate in this assessment to consider 973 mg/L as the lowest end of the short-term 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 9.73 mg/L.

 

PNEC aquatic organisms = short-term toxicity range/100 = 9.73 mg/L

 

PNEC Sewage Treatment Plant (STP)

 

 

Value

Assessment factor

Remarks/Justification

PNEC Sewage Treatment Plant (STP)

66.7 mg/L

10

Based on the results of a ready biodegradability 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 activate sludge simulation study run on the read-across substances Glucose and Maltose. An assessment factor (AF) of 10 is applied to the test concentration of 667 mg/L at which no impact on activate sludge performance is observed, obtaining a PNEC for microorganisms of 66.7 mg/L.

 

PNEC microorganisms = test concentration with no toxicity /10 = 66.7 mg/L

 

PNEC sediment (freshwater)

 

 

Value

Assessment factor

Remarks/Justification

PNEC sediment (freshwater)

3.63 mg/kg

Not applicable

Equilibrium partitioning

Chemical class for Koc – QSAR: Alcohols

Log Kow < -1

 

It is not possible to calculate the PNEC sediment for Syrups, hydrolyzed starch, hydrogenated due to the complex composition of the UVCB substance.

 

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] = 0.973 mg/L

Conversion factor wet-dry suspended matter = 4.6

 

Hence:

PNECsediment wet = (0.932 / 1150) * PNECwater * 1000 = 0.789 mg/kg

PNECsediment dry = 0.789 * 4.6 = 3.63 mg/kg

 

PNEC sediment (marine water)

 

 

Value

Assessment factor

Remarks/Justification

PNEC sediment (marine water)

0.363 mg/kg

Not applicable

Equilibrium partitioning.

Chemical class for Koc – QSAR: Alcohols

Log Kow < -1

 

It is not possible to calculate the PNEC sediment for Syrups, hydrolyzed starch, hydrogenated due to the complex composition of the UVCB substance.

 

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 [marine] = 0.0973 mg/L

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

 

 

Hence:

PNECsediment = (0.932 / 1150) * PNECwater * 1000 = 0.0789 mg/kg

PNECsediment dry = 0.0789 * 4.6 = 0.363 mg/kg

 

 

PNEC soil

 

 

Value

Assessment factor

Remarks/Justification

PNEC soil

0.15 mg/kg

Not applicable

Equilibrium partitioning

Chemical class for Koc – QSAR: Alcohols

Log Kow: < -1

Water solubility: > 10000 mg/L

Vapour pressure: 1210 Pa at 20°C

MW: > 182 g/mol

 

It is not possible to calculate the PNEC sediment for Syrups, hydrolyzed starch, hydrogenated due to the complex composition of the UVCB substance.

 

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 = 0.24 m3 /m3 (according to EUSES2.1)

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

PNECwater [freshwater] = 0.973 mg/L

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

 

Hence:

PNECsoil wet = (0.24 / 1700) * PNECwater * 1000 = 0.137 mg/kg

PNECsoil dry = 0.137 * 1.13 = 0.15 mg/kg

 

PNEC oral

 

 

Value

Assessment factor

Remarks/Justification

PNEC oral

--

--

Not relevant

 

The substance has no potential to cause toxic effects and there are no indications that it bioaccumulates in higher organisms. Based on the low bioaccumulation potential and its ready biodegradability secondary poisoning is not regarded as relevant.

Conclusion on classification

Aquatic Toxicity acute

The fish, daphnia, and algae acute aquatic toxicity are greater than 100 mg/L (96h LC50 (fish) > 1 mg/L, 48h EC50 (daphnia) > 973 mg/L, and 72h ErC50 (algae) > 994 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 100 mg/L (96h LC50 (fish) > 1000 mg/L, 48h EC50 (daphnia) > 973 mg/L, and 72h ErC50 (algae) > 994 mg/L). As well, the substance is very soluble, is anticipated to rapidly degrade, and has a predicted Log Kow of less than -2. 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.