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.
Endpoint summary
Administrative data
Description of key information
Additional information
Substance characterisation
The test substance Orange Oil Bitter is a Natural Complex Substance (NCS) which is a subgroup of Complex reaction products or Biological material (UVCB substances). With 91.5% of the constituent composition of Orange Oil Bitter known, this NCS can be considered as a well defined NCS. The main constituent of Orange Oil Bitter is an alicyclic unsaturated monoterpene hydrocarbon with two double bonds (limonene). In the typical Orange Oil Bitter, the main constituent is D-limonene.
The composition with mainly monoterpene and some minor terpenoid constituents represents a relatively homogenous type of NCS.
In spite of the structural similarities of many constituents, the ranges for water solubility, volatility, adsorption and lipophility are considerable and thus the their environmental behaviour of the constituents may vary. Due to these differences the assessment of the environmental properties of Orange Oil Bitter is based on data for the individual constituents.
Based on the constituent approach as described in the industry protocol for the REACH registration of NCSs of botanical origin used as fragrance ingredients (see footnote 1), Orange Oil Bitter is to be considered as a readily biodegradable substance. The water solubility ranges from 18 to to 1100 mg/l for the constituents.
The log Kow of the constituents ranges from 3.38 to 4.88. With log Kow 4.38, limonene represents the group with a relatively high log Kow (Koc of limonene estimated at 2413). Most constituents may have a tendency to sorb to organic matter.
The estimated vapour pressure of Orange Oil Bitter was 191.3 Pa, ranging from 11 to 320 Pa for the constituents. For D-limonene the vapour pressure is 193 Pa and another 2% of the constituent composition has a higher vapour pressure. This indicates that partitioning by volatilisation will be significant.
Classification
Although Orange Oil Bitter is considered readily biodegradable, log Kow is > 4 for typically 90% of the constituent composition. As there is no tested BCF for Orange Oil Bitter or for its main constituent limonene at the moment, a classification for long-term effects in the environment is applied as a worst case for both the classification according to Directive 67/548/EEC (DSD) and according to Regulation 1272/2008/EC (CLP).
(1) A statement on the use of the protocol for Registration of Natural Complex Substance (NCS) under REACH has been attached to the dossier
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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