Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.052 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.52 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.005 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.025 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:
0.019 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Initial EU and GHS Hazard classification of Propylene Oxide

 

The lowest acute aquatic toxicity value is 52 mg/L for the freshwater fish Salmo gairdneri (new name: Oncorhynchus mykiss). Based on the result of the octanol/water partition coefficient (Log Kow of 0.055) propylene oxide is not expected to significantly accumulate in aquatic organisms. Furthermore, the substance is found inherently biodegradable. For these reasons, propylene oxide is not classified in GHS.

PBT AND VPVB ASSESSMENT

An assessment of the PBT status of propylene oxide has been made using all available data. The information available suggests that propylene oxide does not meet the PBT screening criteria as outlined in Annex XIII of Directive 2006/121/EC.

Persistence

Propylene oxide was found ready biodegradable (89% after 28 days) under aerobic conditions in a modified MITI test (MITI 1988) and can therefore be regarded as not persistent.

Bioaccumulation

No experimental data are available for bioaccumulation of propylene oxide.Based on the result of the octanol/water partition coefficient (Log Kow of 0.055) propylene oxide is not expected to significantly accumulate in aquatic organisms.Therefore, propylene oxide can be regarded as not bioaccumulative.

Toxicity

Experimental data on acute toxicity are available for propylene oxide. All acute L(E) C50values are much higher than the screening criterion of 0.1 mg/L. It can therefore be expected that propylene oxide is not toxic towards aquatic organisms. Furthermore, propylene oxide is classified as carcinogenic and mutagenic Cat. 2. Therefore, propylene oxide is assigned as being toxic.

 

Summary and overall Conclusions on PBT or vPvB Properties

Comparison with the Criteria of Annex XIII An assessment of the PBT status of Propylene oxide has been made using all available data. The information available suggests that PO does not meet the PBT screening criteria as outlined in Annex XIII of Directive 2006/121/EC; that asubstance is identified as a PBT substance if it fulfils the criteria for persistence and for bioaccumulation and for toxicity.

Regarding all available data on biotic and abiotic degradation, bioaccumulation and toxicity it can be stated that the substance does not fulfill the PBT/ vPvB criteria. .

 

Emission Characterisation

Because the substance does not fulfill the PBT and vPvB criteria, no emission characterisation is performed.