Registration Dossier
Registration Dossier
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EC number: 946-638-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on read-across from experimental GLP studies performed on the analogue substance Turkish rose absolute, the key ecotoxicity values of the registered substance are as follow:
- Aquatic Invertebrates: 48-h EC50 was 29.1 mg test material/L (lowest acute E(L)C50)
- Aquatic algae: 72-h ErC50 was 175.0 mg test material/L based on growth rate
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).
Toxicity studies on aquatic organisms performed with the registered substance were not available for annex VII endpoints. However, two experimental studies performed on an analogue substance (Turkish rose absolute) in order to assess its toxicity to aquatic invertebrates and to freshwater algae were available. These studies on the analogue were performed under GLP conditions using Water Accommodated Fractions, in compliance with OECD 201 and 202 guidelines, as well as the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). In addition, these studies have been reviewed and were considered reliable. Indeed, they respected the requirements of both guidelines and the respective validity criteria were fulfilled.
Therefore, it has been decided to use the results from these two studies for the registered substance. The read-across justification can be found in the related iuclid study records.
In the dataset, short-term toxicity to fish was not provided since the tonnage band (1 -10 tonnes/year) does not require that endpoint.
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: sufficient chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L (aquatic invertebrate: 29.1 mg/L), the substance is considered as rapidly degradable but has at least one constituents with a log kow > 4.
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