Registration Dossier
Registration Dossier
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EC number: 283-291-9 | CAS number: 84604-14-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Rosmarinus officinalis, Labiatae.
Endpoint summary
Administrative data
Description of key information
Species |
Guideline |
Result (mg/L) |
Remarks |
Algae |
iSafeRat (non-polar narcosis) for OECDTG 201
|
ErL50: 4.4 |
Key study, reliability K2, WAF calculations Kreatis report |
Daphnia |
iSafeRat (non-polar narcosis) for OECDTG 202 |
EL50: 3.6 |
Key study, reliability K2, WAF calculations Kreatis report |
Fish |
iSafeRat (non-polar narcosis) for OECDTG 203 |
LL50: 3.4 |
Key study, reliability K2, WAF calculations Kreatis report |
Micro-organisms (activated sludge) |
OECDTG301F |
NOEC: 82 mg/L |
Key study, reliability K1, biodeg study |
Additional information
Rosemary oil is a Natural Complex Substance (UVCB) with a well-defined composition for which the relative percentage and its reported variation of each constituent is known.
Therefore, it has been decided that the ecotoxicity of Rosemary oil will be derived from knowledge of the constituents: constituents approach. The mixture ecotoxicity properties may be derived from the ecotoxicity of the individual constituents (as reported in endpoint summary discussions for each species)
Classification should be derived from the most sensible species.
Acute toxicities to aquatic organisms property have been investigated using a calculation method named iSafeRat® that replaces OECD 201, 202 and 203 studies and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions). Two compositions have been investigated, the “typical” composition proposed by the Lead registrant and a theoretical worst case composition, derived from data supplied in the SIP that maximizes the concentration of the most toxic constituents.
The acute aquatic toxicity of multi-constituent substances can be assessed by a multi-step calculation method to simulate the acute aquatic toxicity that would be observed in a WAF (Water Accommodated Fraction) study. This calculation is based on the chemical activity parameter where the activity of a molecule is its effective concentration in a non-ideal solution taking into account the intermolecular interactions. For an accurate prediction, the exact concentration of each constituent in the mixture must be known and used as inputs into the model. A thermodynamic approach calculates the influence of each constituent on their respective solubility allowing the concentration of each constituent within the mixture to be resolved (i.e. providing the “loading rate”). In the second step, the non-bioavailable fraction is removed to determine the true concentration of each constituent exerting toxicity. This concentration is calculated by the model in terms of a fraction of the chemical activity exerted by each constituent. Finally, the loading rate is adjusted until the value of the sum of activities of the bioavailable fractions is equal to the fraction-weighted average of toxic activity of each constituent. This can be seen as mechanistically following the same process which occurs in a WAF study. To check its accuracy, the model has been validated and validation is presented in position paper attached to the dossier.
Using these worst case composition ecotoxicity results are as follow:
- Fish: 96-h LL50 was 3.4 mg test material/L
- Invertebrate: 48-h EL50 was 3.6 mg test material/L
- Algae: 72-h ErL50 was 4.4 mg test material/L
Based on these results, Rosemary oil would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.
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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