Registration Dossier
Registration Dossier
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EC number: 277-143-2 | CAS number: 72968-50-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantium, Rutaceae.
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Hazard for air
Hazard for terrestrial organisms
Hazard for predators
Additional information
Orange Oil Bitter is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The volume is 1-10 tonnes/year, therefore no PNEC is derived and no Hazard assessment or PBT assessment is conducted.
Conclusion on classification
Orange Oil Bitter is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The toxicity of this NCS on algae and Daphnia was not experimentally established. Also for fish, which is not required for this volume, no experimental data were available. For these endpoints read-across was conducted to the group of citrus oils. Data are available for Orange Oil, Mandarin oil and Lime oil. The justification of this read-across is described in detail in the read-across justification document.
For Orange Oil Bitter, the lowest ecotoxicity value (from a range of results for the various citrus oils) is a 48h-EL50 from a Daphnia WAF study with Orange Oil. In this study the 48h-EL50 is 1.1 mg/L. All other studies for citrus oils used for read-across gave higher ecotoxicity values, with EL50 values between 5 and 12 mg/l.
This leads to a classification with R51.
The test substance Orange Oil Bitter was shown to be readily biodegradable.
As all known constituents of Orange Oil Bitter have an estimated log Kow >3 (log Kow over 4 for 90% of the constituent composition) and no measured data on BCF is available for Orange Oil Bitter, it is also classified as R53.
Thus according to Directive 67/548/EEC Orange Oil Bitter is classified as R51/53 (Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).
According to Regulation 1272/2008/EC (CLP) Orange Oil Bitter is classified as hazardous to the aquatic environment Chronic Category 2 (H411).
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