Registration Dossier
Registration Dossier
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EC number: 245-629-3 | CAS number: 23386-52-9
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
Key value for chemical safety assessment
Additional information
In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic toxicity tests shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on daphnids. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB. The hazard assessment reveals neither a need to classify the substance as dangerous to the environment, nor that it is a PBT or vPvB substance nor that there are any further indications that the substance may be hazardous to the environment. The chemical safety assessment according to Annex I indicates no need to investigate further effects on aquatic organisms. Waiving of the long-term toxicity test on invertebrates is in line with the argumentation laid down in Guidance document R.7.b (version 2016) page 59 Figure R.7.8-4.
The chronic daphnia data from docusate sodium (CAS 577-11-7) are used as supporting study. In addition, a further chronic Daphnia study is available for the group (CAS 29857-13-4). When comparing the acute ecotox-results from the later substance (CAS 29857-13-4) with results from the registered substance, the read across to CAS 577-11-7 is more appropriate. Following this conclusion, the read across information to docusate sodium is added and evaluated as supporting information.
In a final decision ECHA disagreed to use the read across data from docusate sodium as key information and requested further support of the underlying assumptions. Therefore, until new data on chronic toxicity become available, the current PNEC derivation (with RCRs < 1) is based on a conservative basis using the acute data for the registered substance in combination with an AF of 1000 for freshwater and an AF of 10000 for marine water.
For the subsequent dossier update by 2024 and in accordance with the ECHA decision, further data on chronic daphnia will be presented and evaluated in a group approach.
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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