Registration Dossier
Registration Dossier
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EC number: 248-107-3 | CAS number: 26919-50-6
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: Expert assessment
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Expert assessment
- Justification for type of information:
- Based on the available information from the chemical safety assessment for the substance, no further risk to fish is identified. Therefore, long term toxicity testing in fish is not required in accordance with column 2 of Annex IX of REACH (see attached report).
- Principles of method if other than guideline:
- An assessment was performed.
- Key result
- Remarks on result:
- other: An assessment was performed. See attached report
- Executive summary:
There is no long-term toxicity data available on the registered substance for invertebrates. Therefore, considerations are primarily based on the short-term toxicity data available. Following conclusions can be drawn from the available studies and chemical safety assessment performed for the substance:
1. The substance as well as the source substances used to support the data requirements are highly soluble in water; therefore, all the available short term toxicity testing data in the dossier are considered appropriate for risk assessment
2. For all exposure scenarios available in dossier, the ratio of PEC to PNEC was <1; therefore, no further risk to invertebrates is identified as a result of chemical safety assessment
3. The partition coefficient of the substance is very low (Log Kow is -0.43) and PEClocal as well as PECregional for all exposure scenarios are very low (<1/1000th of the water solubility)
Based on the available information from the chemical safety assessment for the substance, no further risk to invertebrates is identified. Therefore, long term toxicity testing in invertebrates is not required in accordance with column 2 of Annex IX of REACH.
Reference
Description of key information
This study is considered to be unjustified. In accordance with REACH Annex IX, long-term toxicity testing is not necessary as the chemical safety assessment according to Annex I indicates no further need to investigate the effects on aquatic organisms (see attached justification).
Key value for chemical safety assessment
Additional information
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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