Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 000 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.052 mg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.066 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

Propylidynetrimethanol, ethoxylated shows no acute effects towards aquatic organisms of three trophic levels (algae, crustaceans and fish) at least up to concentrations of 100 mg/L.Propylidynetrimethanol, ethoxylated is neither readily biodegradable (30.3 % in 28 days), nor inherently biodegradable (34 % in 27 days) and the substance is hydrolytically stable at 50 °C at pH 4, 7 and 9. Propylidynetrimethanol, ethoxylated has a low potential to bioaccumulate as reflected by a log Kow = 2.98.

Thus, based on the given substance properties Propylidynetrimethanol, ethoxylated is not classified according to the Dangerous Substances Directive (67/548/EEC) as well as according to Regulation (EC) 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.

Preliminary PBT Assessment  

An assessment of the PBT status of the substance has been made using all available data. The information available suggests that the substance does not meet the PBT screening criteria as outlined in Directive 2006/121/EC (Appendix A).  

Persistence Assessment

In a manometric respirometry test (corresponding to OECD 301 F), a degradation of 30.3 % was determined within 28 days for Propylidynetrimethanol, ethoxylated (Bayer Industry Services (2007). Therefore, this substance has to be classified as "Not Readily Biodegradable". This result is supported by AnoxKaldnes (2008) reporting a degradation of 38 % in 28 days with an OECD 301 A assay. However, AnoxKaldnes (2008) prolonged the test and report of 52 % degradation after 42 days with the plateau of degradation still not being reached. In an OECD 302 C assay on inherent biodegradability, the degradation of Propylidynetrimethanol, ethoxylated was 34 % within 27 days (Currenta, 2009). These results indicate that the substance is inherently biodegradable and therefore identified as not persistent. However, since the substance is not readily biodegradable, the substance has to be classified as P according to the PBT screening criteria.

Bioaccumulation Assessment

In the absence of a measured BCF value, the log Kow can be used as a screening criterion for bioaccumulative potential (i.e. >4.5). As the log KOW of the substance is below 4.5, the B/vB criterion is not met. Therefore the substance is identified as not B.  

Toxicity Assessment

The acute effect information for all three trophic levels is much higher than the screening criterion of 0.1 mg/l. It can therefore be expected that the substance is not toxic towards aquatic organisms.  

Summary and Overall Conclusions on PBT or vPvB Properties

The overall conclusions, based on the present available data, of the preliminary PBT assessment are that the (screening) criteria for PBT/vPvB are not met and that further testing in the scope of the final PBT assessment is not considered to be required.  

Emission Characterisation

The substance is not a PBT/vPvB substance, therefore the emission characterisation does not need to be conducted.