Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.746 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:
2.5 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Key parameters for environmental classification

1) Biodegradation in water: Readily biodegradable, 79% biodegradation in 28 days (OECD 301B)

2) Bioaccumulation: No significant bioaccumulation in biota is expected for this substance (see IUCLID section 5.3 for further information).

3) a) Acute aquatic toxicity:

96 h, LC50 (Danio rerio): > 100 mg/L (nominal; No effects up to the limit of water solubility (WS < 0.15 mg/L))

48 h, EC50 (Daphnia magna): > 1 < 10 mg/L (nominal, WAF); EC50 = 5.05 mg/L (statistical analysis of the raw data)

72 h, EC50 (Pseudokirchneriella subcapitata): > 320 mg/L (nominal; No effects up to the limit of water solubility (WS < 0.15 mg/L) based on growth rate)

 

b) Chronic aquatic toxicity:

72 h, EC10 (Pseudokirchneriella subcapitata): > 320 mg/L (nominal; No effects up to the limit of water solubility (WS < 0.15 mg/L) based on growth rate)

21 d, NOELR (Daphnia magna): 4 mg/L (nominal; WAF)

 

Classification justification according to CLP

Based on the data above, 1,2,3-propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) is considered to be rapidly degradable and has low potential for bioaccumulation. The short-term aquatic toxicity L(E)C50 values are above 1 mg/L for fish, invertebrates and algae. Valid chronic toxicity data are available for invertebrates and algae – the lowest NOEC is 4 mg/L for aquatic invertebrates. Thus, 1,2,3 -propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) does not need to be classified and labelled according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP).

 

Classification justification according to DSD

Based on the available data, 1,2,3-propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) is considered to be rapidly degradable and has a low potential for bioaccumulation. The short-term aquatic toxicity L(E)C50 values are above 1 mg/L for fish, invertebrates and algae. Thus, the substance does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.