Registration Dossier
Registration Dossier
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EC number: 282-025-9 | CAS number: 84082-79-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Salvia officinalis, Labiatae.
Endpoint summary
Administrative data
Description of key information
Based on calculation and experiemental studies on the registered substance, the key ecotoxicity values are as follow:
- Aquatic Invertebrates: 48-h EL50 was 10.23 mg test material/L (geometric mean)
- Aquatic algae: 72-h ErL50 was18 mg test material/L
Based on these results, thelowest acute E(L)C50 is higher than 1 mg/L.
Therefore, the substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.
Additional information
Sage Dalmatian Oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage of the constituents is known.
Short-term toxicity to fish was not provided in the dataset since the tonnage band (1 -10 tonnes/year) does not require that endpoint.
Acute toxicity to aquatic invertebrates (Daphnia magna) has been determined as being the geometric mean between a WAF experimental study performed under GLP compliance in accordance with OECD 202 guideline and an accurate calculation method that mimics the experimental study following the same guideline.
Acute toxicity to algae has been investigated using a valid calculation method that replaces OECD 201 study in guideline for testing of Chemicals No. 23 (i.e.WAF conditions).
For these studies, the typical compositions provided by the supplier of the substance have been investigated.
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 readily biodegradable substance with Log Kow > 4 for at least one constituent.
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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