Registration Dossier

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):
0.084 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:
5 000 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.516 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.152 mg/kg sediment dw
Assessment factor:
10 000
Extrapolation method:
assessment factor

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:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Biodegradation in water: screening tests: 70 -80% (CO2/ThCO2) in 28 d (OECD 301B)

log Pow: <=2.9 (worst-case QSAR, KOWWIN)

Acute toxicity:

to fish: LC50 (96 h) = 129 mg/L for Leuciscus idus (DIN 38412), 78.4 mg/L for Cyprinodon variegatus (PARCOM 1995 B)

to algae: ErC50 (72 h) = 8.4 mg/L for Skeletonema costatum (ISO 10253)

to crustacea: EC50 (48 h) = 19.95 mg/L for Acartia tonsa (ISO 14669)

Chronic toxicity:

to fish: NOEC = 1.8 mg/L for Danio rerio (OECD 204)

to algae: NOEC (72 h) = 3.5 mg/L for Skeletonema costatum (ISO 10253)

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

 

 

Classification justification according to CLP

Based on the data above, Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols 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 andaquatic invertebrates. Valid chronic toxicity data are available for all three trophic levels - the lowest EC10 is 1.76 mg/L for Daphnia.

Therefore, Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols does not need to be classified and labeled 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, Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols 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, aquatic invertebratesand algae. Reaction products of D-Glucose, n-Butanol and C10-12 (even numbered) alcohols does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.