Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.037 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:
0.015 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC aqua (freshwater), PNEC aqua (marine), PNEC aqua (intermittent release)

There are data from acute studies in green alga (freshwater) and aquatic invertebrates (freshwater) as well as a QSAR prediction for freshwater fish for methyl-a-D-glucopyranoside, but no long-term or reproduction study, nor studies with marine organisms. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied and the PNEC aqua (freshwater) was derived from the 48 h NOEC value of > 100 mg/L, determined with aquatic invertebrates ( Daphnia magna), the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 0.1 mg/L.

An assessment factor of 10000 was applied and the PNEC aqua (marine) was derived from the 48 h NOEC value of 100 mg/L, aquatic invertebrates (Daphnia magna). This results in a PNECaqua (marine) of 0.01 mg/L. 

An assessment factor of 100 was applied to the NOEC value, which was the 48h NOEC > 100 mg/L,with aquatic invertebrates (Daphnia magna). Thus, the PNECaqua(Intermittent release) was calculated to be 1 mg/L. 

PNEC STP

The PNEC STP was based on the NOEC of 100 mg/L obtained in a Ready Biodegradability - Warburg respirometer Test. Based on the available data, an assessment factor of 10 was applied in accordance with the Guidance in Information requirements and chemical safety assessment, R.10, to calculate the PNEC STP = 10 mg/L.

PNEC air

The registration substance has a low vapour pressure of 1.89E-06 Pa at 25°C. Based on this no risk for air breathing animals and humans is expected. 

PNECoral (secondary poisoning)

Bioaccumulation potential has been estimated to be low. There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived. 

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning method using EUSES 2.1. 

The following data have been taken into account for calculation: Molecular weight 194.18 g/mol,Vapour pressure1.89E-06 Pa at 25°C, Water solubility 9.12E04 mg/L at 25°C, Log Kow -2.5

 

 

The following data have been taken into account for calculation: 

Molecular weight

194.18 g/mol

Melting point

168°C

Vapour pressure

1.89E-06 Pa at 25°C

Water solubility

9.12E04 mgL at 25°C

Log Kow

-2.5 (set to a minimum value of -1 in EUSES)

PNEC Aqua(freshwater)

0.1 mg/L

PNEC Aqua(marine water)

0.01 mg/L

 

The calculation resulted in a PNEC sediment(freshwater) of 0.366 mg/kg sediment dw, a PNEC sediment (marine waters) of 0.0366 mg/kg sediment dw and a PNEC soil of 0.0146 mg/kg soil dw.

Conclusion on classification

The most sensitive organism to alpha methyl glucoside was the freshwater invertebrate (Daphnia magna). Thus, the lowest acute toxicity value is the 48h NOEC to the water flea (Daphnia magna) of 100 mg/L. This value was used for the calculation of PNECs.

Based on these results alpha methyl glucoside does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).