Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.176 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.2 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.018 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.072 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:
0.654 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

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

Additional information

Studies with organisms from the aquatic and terrestrial compartment are available and thus, the PNECs are based on the test results and assessment factors recommended in the Technical Guidance Document (ECHA, 2008) have been applied. For the freshwater sediment, no studies have been conducted and the PNECs have been calculated using the Equilibrium Partitioning Method (EPM) as screening values. The EPM was used for the the calculation of the PNEC sediment (marine water) as well because only short-term studies are available.

The PNEC oral is derived from a toxicological endpoint as the toxicity towards birds has not been tested.

Conclusion on classification

Classification related key information

Biodegradation in water: screening tests: 71% (CO2 consumption) in 28 d (OECD 301D)

log Kow: 1.72 (EU method A.8)

Acute toxicity:

to fish: LC50 (96 h) = 420 mg/L for Oncorhynchus mykiss (OECD 203)

to algae: ErC50 (72 h) = 780 mg/L for Scenedesmus subspicatus (OECD 201)

to crustacea: EC50 (48 h) = 490 mg/L for Daphnia magna (OECD 202)

Chronic toxicity:

to fish: NOEC (28 d) = 1.8 mg/L for Brachydanio rerio (OECD 204)

to algae: NOErC (72 h) = 125 mg/L for Scenedesmus subspicatus (OECD 201)

to crustacea: EC10 = 1.76 mg/L for Daphnia magna (OECD 202 part II)

Classification justification according to CLP

Based on the data above, D-Glucopyranose, oligomers, hexyl glycosides is considered to be rapidly degradable and have low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish, algae andDaphnia. Valid chronic toxicity data are available for three trophic levels - the lowest EC10 is 1.76 mg/L forDaphnia. Therefore, D-Glucopyranose, oligomers, hexyl glycosides does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

Classification justification according to DSD

Based on the data above, D-Glucopyranose, oligomers, hexyl glycosidesis considered to be rapidly degradable and have low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish,Daphniaand algae. D-Glucopyranose, oligomers, hexyl glycosides does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.