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EC number: 221-336-6
CAS number: 3069-29-2
Table 1. Test results
Nominal test concentration (mg/kg dry weight)
Mean percentage mortality – Day 7
Mean percentage mortality – Day 14
Mean body weight per worm (+/-Std. Dev.) – Start of test
Mean body weight per worm (+/-Std. Dev.) – Day 14
Mean percentage decrease in body weight per worm over the test period
*Mean decrease not significantly different to Control (p<0.05)
LC50 (14-day): >1000
mg/kg dry weight, mortality, Eisenia foetida, read-across from
CAS 1760-24-3 (RCC, 2004).
NOEC of =1000 mg/kg dry weight,
mortality and growth, Eisenia foetida, read-across from CAS
1760-24-3 (RCC, 2004).
A 14-day LC50 of
>1000 mg/kg dry weight and NOEC of =1000 mg/kg dry weight have been
determined for the effects of the structurally analogous substance
N-(3-(trimethoxysilyl)propyl)ethylenediamine on mortality of Eisenia
foetida. A NOEC of =1000 mg/kg dry weight has also been determined
for effects on growth. It is likely that under the moist test conditions
employed in the test that the test organisms were exposed to the
hydrolysis products of the test substance,
Further information on read-across
is given in IUCLID Section 6 endpoint summary (CSR Section 7.0) and in
the ecotoxicity RAAF attached in Section 13 of IUCLID.
The registration substance
falls within soil hazard category 3 as defined in REACH R.7 (ECHA 2017);
high persistence (DT50 >180 days) but there is no indication
that the substance is very toxic to aquatic organisms (E(L)C50
In this situation, a
screening approach is applied: a confirmatory long-term terrestrial test
in addition to the equilibrium partitioning approach with an extra
factor of ten.
The PEC × 10 / PNECscreen
based on the equilibrium partitioning method indicates the substance
will have a risk characterisation ratio (RCR) >1. The
highest terrestrial RCR based on PEC x 10 / PNEC is 4.69 related to
deposition from air.
ECHA guidance Chapter R.7c,
Table R.7.11—2 states the following (ECHA 2017): If PEC/PNECscreen > 1
or indication of risk from confirmatory long-term soil toxicity test:
Conduct long-term toxicity tests according to the standard information
requirements Annex X (invertebrates and plants), choose lowest value for
derivation of PNECsoil.
A long-term toxicity to
terrestrial invertebrates test in accordance with test guideline OECD
222 is therefore proposed. In
view of the rapid hydrolysis rate of the registration substance, the
relevant assessment entity is the silanol hydrolysis product
N-[3-(dihydroxymethylsilyl)propyl]ethylenediamine. The parent substance
should therefore be pre-hydrolysed prior to exposure of test organisms.
tiered testing approach is proposed with the OECD 222 test to be
conducted first in order to
establish that stability and homogeneity is feasible for the earthworm
study prior to conducting the plant test.
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
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.
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