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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Ecotoxicological information

Toxicity to terrestrial plants

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to terrestrial plants: long-term
Type of information:
experimental study planned
Study period:
After approval by ECHA
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants, Growth Test)
Principles of method if other than guideline:
The study is to be conducted with the hydrolysis product of the registered substance, in view of its hydrolysis rate - see IUCLID Section 6.3, CSR Section 7.2, for further details of the risk assessment approach.
A 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 test prior to conducting the OECD 208 plant test.

Description of key information

Key value for chemical safety assessment

Additional information

No terrestrial plant toxicity data are available with N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine (CAS 3069-29-2).

An OECD TG 208 study is proposed with the registration substance.

 

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 <1 mg/l).

 

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 plants test in accordance with test guideline OECD 208 is therefore proposed.

A 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 test prior to conducting the OECD 208 plant test.