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EC number: 252-161-3
CAS number: 34708-08-2
OECD TG 222 Test Proposal
In the context of the Integrated Testing Strategy for the terrestrial
compartment (ECHA guidance Chapter R.7c, terrestrial hazard
classification scheme, Table R.7.11—2) (ECHA 2017) the substance is
assigned to the soil Hazard Category 3 (see IUCLID Section 6.3 and CSR
Section 7.2 for further details).
In this situation, a screening
approach is applied, where the equilibrium partitioning risk assessment
approach with an extra factor of ten, in addition to a confirmatory
long-term terrestrial test, are to be conducted:
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 is 8.48 in agricultural soil.
Confirmatory long-term test:
An OECD 222 study with earthworms is proposed with the hydrolsis product
of the registered substance.
In addition, ECHA guidance Chapter R.7c, Table R.7.11—2 states the
following: "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 IX or X
(invertebrates and plants), choose lowest value for derivation of
PNECsoil". The PEC/PNECscreen is >1, which indicates that standard
information requirements according to Annex IX or X should be conducted.
However, a long-term aquatic toxicity study with invertebrates OECD 211
is proposed, which is likely to affect the PEC/PNECscreen. Therefore,
it is proposed to review the results of the screening assessment once
the OECD 211 and 222 study results are available, before concluding on
the need to conduct the OECD 208 plant study.
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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