Registration Dossier
Registration Dossier
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EC number: 203-678-8 | CAS number: 109-53-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Long-term effects to fish are expected.
Key value for chemical safety assessment
Additional information
- Ethers are a member of the ECOSAR class “Neutral Organics”.
- Isobutyl vinyl ether is classified as basesurface narcotics (and narcosis/baseline toxicity) by the modified acute aquatic toxicity scheme of Verhaar and the acute aquatic toxicity MOA scheme of OASIS. No alert for protein binding was found (OASIS, OECD). There are no indications for excess toxicity above the baseline.
QSAR-Disclaimer:
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of the substance, (Q)SAR results were used for the estimation of the long-term toxicity to fish. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Therefore, experimental studies on the long-term toxicity to fish are not provided.
Assessment:
Relevant experimental data for this information requirement do not exist neither for the substance. It was not possible to retrieve sufficient data to fill the data gap using trend analysis or a read-across approach with OECD QSAR Toolbox v4.5.
The ECOSAR v2.2 model (US EPA, 2022) was used to predict the chronic toxicity. The chronic value ChV is defined as the geometric mean of the no-observed-effect concentration (NOEC) and the lowest-observed-effect concentration (LOEC). ECOSAR v2.2 classifies the substances primarily as "Vinyl/Allyl Ethers". However, the QSAR models for this ECOSAR class are not reliable as they are derived from a very low number of substances (n ≤ 4). In addition, the results for the chronic effect values for fish and daphnids were derived using an acute to chronic ratio, which is also not reliable, especially as documentation of the database is lacking.
Therefore, the prediction for the neutral organic SAR was used to assess the long-term toxicity for fish. This classification is justified as
The ChV for isobutyl vinyl ether was predicted to be 0.989 mg/L. The substance is within the applicability domain of the model.
It can be concluded that long-term effects to fish are expected.
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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