Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.006 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.644 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 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:
0.018 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Classification related key information

Biodegradation in water: screening tests:

86.7% biodegradation in 28 days (OECD 301B)  

                                                 

Bioaccumulation:                       

No significant bioaccumulation in biota is expected for this substance (see IUCLID section 5.3).

 

Acute toxicity:

-         Fish: LC50 (96 h) > 77.9 mg/L for Oncorhynchus mykiss (OECD 203)

-         Aquatic invertebrates: EC50 (48 h) = 64.4 mg/L for Daphnia magna (OECD 202)

-         Algae: ErC50 (72 h) > 72.6 mg/L for Pseudokirchneriella subcapitata (OECD 201)

Chronic toxicity: 

-         Algae: NOErC (72 h) = 0.565 mg/L for Pseudokirchneriella subcapitata (OECD 201)

Classification justification according to CLP

Based on the data above, Glycerides, palm-oil mono-, hydrogenated, acetates (CAS No. 93572-32-8) is considered to be rapidly biodegradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish, aquatic invertebrates and algae. Therefore, Glycerides, palm-oil mono-, hydrogenated, acetates does not need to be classified and labeled as acute aquatic hazard according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

 

Valid chronic toxicity data are available for algae, resulting in a NOEC value < 1 mg/L.Thus, the substance needs to be classified and labeled as long-term aquatic Chronic Category 3 according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

 

M-factor: not to be assigned

 

Classification justification according to DSD

Based on the data above, Glycerides, palm-oil mono-, hydrogenated, acetates (CAS No. 93572-32-8) is considered to be rapidly biodegradable and have low bioaccumulation potential. The acute aquatic toxicity tests available resulted in EC50 values > 1 mg/L for fish, aquatic invertebrates and algae. Thus, the substance does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.