Registration Dossier
Registration Dossier
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EC number: 946-584-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The key ecotoxicity values of the registered substance are as follow:
- Fish: study scientifically not necessary
- Aquatic Invertebrates: 48-h EL50 was > 100 mg test material/L
- Aquatic algae: 72-h ErL50 was 77.722 mg test material/L
- Microorganisms: NOEC = 100 mg/L
Based on these results, the lowest acute E(L)C50 is higher than 1 mg/L.
Therefore, the registered substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.
Additional information
The registered substance is a Natural Complex Substance (UVCB).
For annex VII required endpoints, Acute toxicities of the registered substance to aquatic invertebrates (Daphnia magna) and to freshwater algae (P. subcapitata) have been determined in experimental studies using WAFs and performed under GLP compliance in accordance with OECD 202 and 201 guidelines respectively. The respective validity criteria were fulfilled and both studies complied with the requirements of the test guidelines. These studies were therefore considered acceptable for these endpoints.
For annex VIII required endpoints, the assessment of the short-term toxicity to fish of the registered substance has been waived. Indeed, considering no or low toxic effects on aquatic invertebrates and algae at tested highest loading rates and the apparent low solubilisation of constituents of the substance, toxicity to fish is not expected. Therefore it was not considered necessary to perform a study on a vertebrate.
Moreover, an ASRIT study was also considered scientifically not necessary, because the registered substance is not toxic to microorganisms at 100 mg/L. Indeed, in the ready biodegradability study performed on the registered substance, the test item was not inhibitory to the aerobic activated sludge microorganisms in the toxicity control (OECD 301F).
CLP Classification proposal
It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).
Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.
Chronic aquatic hazard: category 3. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L, not rapidly degradable substance with some constituents having log kow > 4.
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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