Registration Dossier
Registration Dossier
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EC number: 203-678-8 | CAS number: 109-53-5
Endpoint summary
Administrative data
Description of key information
No data available
Additional information
Toxicity to soil organisms
In Annex X, Section 9.4, Column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment indicates the need to investigate further the effects of the substance or of relevant transformation and degradation products on terrestrial organisms.
According to the principle of the soil hazard categories of the REACH Guidance Document R.7c (Table R.7.11-2; ECHA, 2017), the substance is assessed as Hazard Category 1. This category includes substance where there is no indication for high adsorption (log Kow > 5, ionisable substances) or high persistence (DT50 > 180 d) as well as no indication for the substance being very toxic (LC/EC50 < 1 mg/L). Isobutyl vinyl ether is readily biodegradable (see IUCLID Ch. 5.2.1). The substance has no significant potential for adsorption (see IUCLID Ch. 5.4.1). The substance is not very toxic with acute effect values >> 1 mg/L. Therefore, the equilibrium partitioning method can be applied as a first screen.
As soil is not an environmental compartment of concern, no test on toxicity to terrestrial organisms is performed. The equilibrium partitioning method has been used for assessing the hazard to soil organisms.
Toxicity to birds
No relevant data on the long-term toxicity to birds are available for the substance.
In Annex X, Section 9.6.1, Column 2 of Regulation (EC) No 1907/2006, it is laid down that any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. Furthermore, the REACH Guidance Document R.7c (ECHA, 2017) states "Given that mammalian toxicity is considered in detail for human health protection, the need for additional data for birds must be considered very carefully – new tests are a last resort in the data collection process.
In case of isobutyl vinyl ether (CAS 109-53-5), a mammalian dataset is available. The substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. Significant bioaccumulation in organisms is not to be expected based on the substance’s low log Kow and low estimated BCF (see IUCLID Ch. 4.7 and 5.3.1). In addition, the substance does not fulfil the criteria for PBT or vPvB substance.
Hence, secondary poisoning is of no concern.
Therefore, and for reasons of animal welfare, no tests on birds are performed.
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.
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