Registration Dossier
Registration Dossier
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EC number: 289-995-2 | CAS number: 90063-37-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula angustifolia, Labiatae.
Endpoint summary
Administrative data
Description of key information
The key ecotoxicity values of the registered substance are as follow:
- Fish: 96h-LL50 was 29.173 mg test material/L
- Aquatic Invertebrates: 48-h EL50 was 21.995 mg test material/L
- Aquatic algae: 72-h ErL50 was 13 mg test material/L (lowest acute E(L)C50 value)
- Microorganisms: 3h-EC50 = 1230 mg/L and 3h-NOEC = 488 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
For annex VII and VIII endpoints, studies performed on the registered substance were available for the three trophic levels: fish, daphnids and algae.
Key acute toxicities to the zebrafish Danio rerio and to Daphnia magna have been determined with experimental OECD 203 and 202 studies respectively. In both tests, the quality which is the most representative in Europe has been tested. The two studies were realised under GLP conditions and the test item was exposed to WAF, according to the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). Both studies respected the requirements of the test guidelines and were considered valid.
Acute toxicity to algae has been determined using a calculation method that replaces an OECD 201 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). For this study, typical compositions of the different qualities of the registered substance have been investigated. The key value selected for that endpoint was the most conservative result amongst the qualities. This calculation method was based on HA-QSARs fully validated following the OECD (2004) recommendations. Therefore, this calculation method was considered acceptable to be used alone to fulfill that endpoint.
In addition, the registered substance can be considered as not toxic to microorganisms, based on the results of a reliable experimental OECD 209 study.
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 of some constituents > 4.
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