Registration Dossier
Registration Dossier
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EC number: 479-940-2 | CAS number: 613246-75-6
Endpoint summary
Administrative data
Description of key information
Additional information
Stability
Hydrolysis
Sika Härter LJ belongs to a class of polyaldimine compounds used as hardeners for polyurethane moisture hardening preparations. Upon contact with water, the hardening process is initiated and the hardener rapidly degrades. The hydrolysis products are Polyetheramin D230 (CAS No. 9046-10-0) and 2,2-Dimethyl-3-lauroyloxy-propanal (CAS No. 102985-93-3). According to non-GLP data from the manufacturer hydrolysis of Sika Härter LJ is acid catalysed. In order to assess the hydrolysis time different hydrolysis measurements (short term and long term) with flow injection analysis mass spectrometry (FIA-MS) were tested. A direct injection of the test item diluted in water free methanol into the FIA-MS, exposed to acetous and bidest. water, was performed for the short term measurement. The long term measurement contained the exposure of the test item with bidest water, acetous water and slightly carbonated water and the periodical recording of the FIMS measures. The results are as follows:
a) hydrolysis with acetous water (1% acetic acid):< 2 sec
b) hydrolysis with bidest. water.>> 2 sec
c) hydrolysis with acetous water as a function of time:< 5 min
d) hydrolysis with bidest. water as a function of time:≥ 20 min
e) hydrolysis with slightly carbonated water as a function of time:< 20 min
Due to its use, Sika Härter LJ has a very limited stability in water as it needs to react rapidly upon contact with water.
Biodegradation
Biodegradation in water:screening tests
Sika Härter LJ was tested for ready biodegradability in the Manometric Respirometry Test according to OECD guideline 301F and EU method C.4.
The test item can be considered as "not readily biodegradable". The degree of biodegradation reached 30% after 28 days. The 10 d-window began on day 5 and 25% were reached at its end, staying below the pass level of 60% degradation based on oxygen consumption. However, Sika Härter LJ is considered to be inherently biodegradable.
Transport and distribution
Adsorption/desorption
The performance of the adsorption/desorption screening test with the registration substance is technically not feasible because of tits rapid hydrolisation. An evaluation of the adsorption potential of its hydrolysis products is scientifically unjustified in accordance with REACH Annex VIII, section 9.3.1, column 2.
Upon contact with water, the hardening process is initiated and the hardener rapidly degrades. The hydrolysis depending from the pH was measured by using flow injection analysis mass spectrometry (FIA-MS) (please refer to IUCLID section 5.1.2). It was demonstrated that the substance rapidly, i.e. within seconds to minutes, hydrolytically degrades to Polyetheramin D230 (CAS No. 9046-10-0) and 2,2-Dimethyl-3-lauroyloxy-propanal (CAS No. 102985-93-3). A study on adsorption/desorption is thus technically not feasible. Therefore, in accordance with REACH Annex XI, this endpoint was waived.
Further, the log Pow of the hydrolysis product Polyetheramin D230 is far below the trigger value of 3 for adsorption potential as indicated in the ECHA Guidance on Information Requirements and Safety Assessment, Chapter 7.a, Endpoint Specific Guidance (version 6.0, July 2017; currently being updated). Ionisation of the molecule and surface active properties are not expected. Consequently, adsorption/desorption is considered not relevant for Polyetheramin D230. The other hydrolysis product, 2,2-Dimethyl-3-lauroyloxy-propanal, has been proven to be readily biodegradable and rapidly degraded by hydrolysis.
In conclusion, studies on the adsorption potential of the registration substance as well as of the hydrolysis products are not justified in accordance with REACH Annex XI, section 2 (study with parent compound technically not feasible) and REACH Annex VIII, section 9.3.1, column 2 (study on adsorption/desorption of hydrolysis products scientifically not necessary).
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