Registration Dossier
Registration Dossier
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EC number: 294-470-6 | CAS number: 91722-69-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula hybrida, Labiatae.
Endpoint summary
Administrative data
Description of key information
The key ecotoxicity values are as follow:
- Aquatic Invertebrates: 48-h EL50 was 14 mg test material/L (lowest acute E(L)C50 value)
- Aquatic algae: 72-h ErL50 was 21 mg test material/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
Lavandin essential oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the typical percentages of the constituents are known, for the four qualities of the substance.
Key acute toxicities to daphnids and algae have been determined using a calculation method that replaces OECD 201 and 202 studies and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). For these studies, the typical compositions of the four qualities have been investigated. This calculation method is based on HA-QSARs fully validated following the OECD (2004) recommendations. In addition, when results of an experimental OECD 202 study and of the calculation method are compared, it appears that the calculation method gives an accurate prediction although being slightly more conservative than the test result. Therefore, this calculation method can be considered acceptable to be used alone to fulfill ecotoxicological endpoints.
Short-term toxicity to fish was not provided in the data set because the tonnage band does not require this 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: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L, rapidly degradable substance with 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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