Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- other: On-going study
- Adequacy of study:
- other information
- Study period:
- Analytical method development initiated in May 2022 and the method validation will initiate in July 2022. The range finder of the OECD TG 211 will initiate in July 2022 and the definitive test in August 2022.
- Justification for type of information:
- To cover the information requirement for long-term toxicity on aquatic invertebrates (ECHA Guidance R.7.8.4.1), the testing proposal to conduct Daphnia magna reproduction test (test method: EU C.20/OECD TG 211) was submitted in a previous submission and was accepted in ECHA decision letter (TPE-D-2114557760-45-01/F). Therefore, the Daphnia magna reproduction test (EU C.20/OECD TG 211) is currently underway. The audited draft report is anticipated to be available in November 2022. Please refer to the statement from the lab under attached justification on the status of the study.
Reference
Description of key information
Key value for chemical safety assessment
Additional information
To cover the information requirement for long-term toxicity on aquatic invertebrates (ECHA Guidance R.7.8.4.1), the testing proposal to conduct Daphnia magna reproduction test (test method: EU C.20/OECD TG 211) was submitted in previous submission and was accepted in ECHA decision letter (TPE-D-2114557760-45-01/F). Therefore, the study was initiated. As the test substance is complex and with low solubility, it took us some time to find the right lab to perform the study and the timelines mentioned above were the earliest they could provide us. This has led to the delay of the study results.
The final results from the study are expected to be available by the end of 2022.
The analytical chemistry method development work was initiated in May 2022 with the results expected to be available in June 2022. The method development work does not require a report. The method validation work will initiate in July 2022 with the audited draft expected to be available in September 2022. The OECD TG 211 has an anticipated timeline of the range finding study initiating in July 2022 and the definitive testing to commence in August 2022. The unaudited results for the range finder and definitive test will be available approximately two weeks after the range finding terminates and approximately three weeks after the completion of the definitive study, respectively. The audited draft report is anticipated to be available in November 2022.
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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