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Description of key information

Stability


The hydrolysis behaviour of 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether in dependence of pH was assessed according to the OECD Guideline 111 (‘Hydrolysis as a function of pH’) and EU method C.7 (‘Degradation: Abiotic degradation: Hydrolysis as a function of pH’). Sterile aqueous buffer solutions of different pH values (pH 4, 7 and 9) were treated with the test item solution and incubated in the dark under controlled laboratory conditions (at constant temperatures). Samples were taken at the beginning and after five days for analysis for the test item.


The amount of test item after five days in all three buffer solutions at 50°C was more than 90% of the amount at the start of the test, therefore the test item was considered to be hydrolytically stable (following OECD Guidelines, t(0.5) at 25°C is considered to be greater than 1 year) and no further examination was made beyond the tier 1 assessment. There were no observations which aroused doubts concerning the accuracy of the results and the validity of the study.


 


Biodegradability


An OECD 302B inherent biodegradability study is available for 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether, the results of which showed that the percentage dissolved organic carbon (DOC) reduction measured after 28 days (at day 29) in both test mediums (TI and TII) was 11% after correction for the DOC contribution from the inoculum.  1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether therefore cannot be regarded as ultimately biodegradable.


 


Bioaccumulation


Indirect exposure of the aquatic compartment is likely.  Data are available for the log Pow of the substance's main components at 25°C, with the two main components' log Pow values ranging from 1.5 to 3.0 and the third component showing a log Pow value of 4.8, thus the bioaccumulation potential of 1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether is considered uncertain based on log Pow alone. The bioaccumulation potential of 1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether was therefore estimated in the VEGA software (version 1.2.3) using the CAESAR (version 2.1.14) and NN/Read-Across (version 1.1.0) QSAR models, however these predictions were shown to be unreliable. It is therefore not possible to reliably assess the bioaccumulation potential of the substance according to Annex XI of the REACH regulation on the basis of the available information.  Therefore in accordance with Column 2 of Annex IX of the REACH regulation a fish bioaccumulation study is required to assess the bioacculation potential of the substance.  As such, a testing proposal is submitted for the performance of an OECD 305 Guideline study to reliably assess the bioaccumulation potential of the substance.


 


Transport and distribution


In accordance with OECD Guideline 121 (2001), an adsorpotion on soil and sewage sludge was carried out in a study via HPLC. As the substance is a multi-constituents substance containing three different components with different structures, rendering it not possible for one Log Koc to be determined. Therefore, three individual Log Koc values were determined for each the sewage and soil samples.


 

























 Component Log Koc Sewage Log Koc Soil
 

Pentaerythritol diallylether 


 1.8 1.7
 

Pentaerythritol triallyl ether


 2.8 2.7
 

Pentaerythritol tetraallyl ether


3.8  3.5

 


Additionally, according to Table R.7.1-14 of the ECHA Guidance on Information Requirements and Chemical Safety Assessment – Chapter R.7a: Endpoint specific guidance (Version 6.0, July 2017), the OECD 302B Guideline (Inherent biodegradability: Zahn-Wellens/EVPA Test) can be used to assess the extent of adsorption of the test substance to STP sludge. 


If significant apparent dissolved organic carbon (DOC) removal is shown to occur within the first 3-hours of the test, it is assumed that this removal has occurred too rapidly to have resulted from microbial degradation processes and it is instead assumed to be the result of a phase transfer from solution caused by adsorption (e.g. to walls of the test vessel and/or activated sludge inoculum). Adsorbed test substance will therefore be obscured from the analysis used to measure residual DOC in the test.


 


A reliable OECD 302B study is available for 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether (Carlsson, 1997) which showed that there was no such DOC loss at 3-hours (or at any other point in the test), therefore it is concluded that 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether does not have significant adsorption tendency.


 

Additional information