Registration Dossier
Registration Dossier
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EC number: 945-898-3 | CAS number: 97675-63-3
Endpoint summary
Administrative data
Description of key information
The key ecotoxicity values are as follow:
- Fish: 96h-LL50 was 3.5 mg test material/L
- Aquatic Invertebrates: 48-h EL50 was 2.3 mg test material/L (lowest acute E(L)C50 value)
- Aquatic algae: 72-h ErL50 was 5.2 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) with a well-defined composition for which the typical percentages of the constituents are known, as well as their ranges within the mixture.
Therefore, the ecotoxicity of the substance may be derived from knowledge of the constituents.
In this context, acute toxicity to fish, daphnids and to algae have been investigated using a valid calculation method that mimic experimental studies in WAF conditions following respectively OECD 203, OECD 202 and OECD 201 guildeines. For these studies, a typical composition of the substance has been assessed.
Moreover, an experimental study performed on the registered substance in order to determine its acute toxicity to Daphnia magna was available. This study was realised in accordance with OECD 202 guideline, in WAF conditions and under GLP conditions. This study respected the requirements of the test guideline and was considered reliable. For that endpoint,the geometric mean between the toxicity values of the experimental study and of the valid calculation method has been selected as the key value.
In addition, perform an ASRIT study was considered scientifically not necessary, because the registered substance was found to be not inhibitory to microorganisms at a concentration of 100 mg/L, in a manometric respirometry test performed according to the OECD 301F guideline. For that endpoint, a NOEC of 100 mg/L can therefore be proposed for the registered substance.
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 2. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 1 and 10 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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