Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-336-6 | CAS number: 3069-29-2
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Due to the very rapid hydrolysis half-life of the registration substance, chemical safety assessment is based on the properties of the hydrolysis products N-[3-(dihydroxymethylsilyl)propyl]ethylenediamine and methanol. The considerations below relate to the silanol hydrolysis product N-[3-(dihydroxymethylsilyl)propyl]ethylenediamine.
Testing for long-term toxicity to fish is not considered necessary because:
In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that further testing is not justified for the following reasons:
A PNEC has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.
N-[3-(Dihydroxymethylsilyl)propyl]ethylenediamine is highly water-soluble, has low bioavailability based on log Kow <3 (-4 at pH 7, corrected for ionisation), especially in pH neutral conditions, and evidence from data available within the analogue group of amine substances suggests that fish are the least sensitive trophic level.
The substance or the structural analogue N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3), have short-term data available for three trophic levels, as well as long-term invertebrate toxicity data. Based on this available aquatic data the most sensitive trophic level is algae, for which the EC50 is approximately one hundred fold lower than the LC50 for fish. Furthermore, effects observed in the short-term toxicity to fish test occurred when the substance was tested at high concentrations, well above 100 mg/l.
Overall it is concluded that the risk is adequately assessed using the short-term data and the long-term invertebrate test, and that in vivo testing on vertebrate animals is not considered necessary or justified on ethical grounds. Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0, CSR Section 7, and Chapters 9 and 10 of the Chemical Safety Report, respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
