Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.377 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Degradation

Biodegradation: 78% biodegradation in 21 days (OECD 301B)    

                                                                     

Bioaccumulation:                       

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

 

Acute aquatic toxicity:

Fish (Oryzias latipes): LC50 (96h) > 102.8 mg/L (meas. geom. mean); read across

Aquatic invertebrates (Daphnia magna): EC50 (48h) = 37.7 mg/L (meas. geom. mean)

Aquatic algae (Pseudokirchnerella subcapitata): EC50 (72h) > 0.125 mg/L (meas. geom. mean)

 

Chronic aquatic toxicity:

Aquatic invertebrates (Daphnia magna): NOEC (21d) = 1.85 mg/L (meas. TWA); read across

Aquatic algae (Pseudokirchnerella subcapitata): NOEC (72h) = 0.0113 mg/L (meas. geom. mean)

 

Classification justification according to CLP

Based on the data above, Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) is considered as rapidly degradable. The acute aquatic toxicity EC50 values are > 1 mg/L for fish and aquatic invertebrates. The toxicity to aquatic algae was above the highest measured concentration with EC50 > 0.125 mg/L (meas. geom. mean). Therefore, Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) needs not to be classified and labelled according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

Valid chronic data are available for aquatic invertebrates and algae with the lowest NOEC for algae of 0.0113 mg/L. Therefore, Oleic acid, monoester with oxybis(propandiol) needs to be classified and labeled as long-term aquatic hazard Chronic Category 2 according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

 

M-factor for acute and chronic aquatic toxicity: not to be assigned

 

Classification justification according to DSD

Based on the data above, Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) is considered to be rapidly biodegradable and have low bioaccumulation potential. The acute aquatic toxicity EC50 values are > 1 mg/L for fish and aquatic invertebrates. The toxicity to aquatic algae was above the highest measured concentration with EC50 > 0.125 mg/L (meas. geom. mean). Therefore, Oleic acid, monoester with oxybis(propandiol) (CAS 49553-76-6) needs not to be classified and labelled as environmental hazard according to the Directive 67/548/EEC.

Conclusion on classification