Registration Dossier
Registration Dossier
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EC number: 284-521-0 | CAS number: 84929-38-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus nobilis, Rutaceae.
Endpoint summary
Administrative data
Description of key information
Additional information
Substance characterisation
The test substance Mandarin oil is a Natural Complex Substance (NCS) which is a subgroup of Complex reaction products or Biological material (UVCB substances). With 97% of the constituent composition of Mandarin oil known, this NCS can be considered as a well defined NCS. The constituents of Mandarin oil are predominantly alicyclic unsaturated monoterpene hydrocarbons with one or more double bonds. In the typical Mandarin oil, the main constituent D-limonene is present at 70% of the composition.
The composition with monoterpenes and some minor terpenoid constituents represents a relatively homogenous type of NCS. The environmental risk assessment will be based on the properties of the main constituent D-limonene. This constituent was identified using the so-called DPD+ approach. In spite of the structural similarities of many constituents, the ranges for water solubility, volatility, adsorption and lipophility are considerable and thus the environmental behaviour of the constituents may vary. Due to these differences the assessment of these environmental properties of Mandarin oil 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), Mandarin oil is to be considered as a readily biodegradable substance.
The water solubility ranges from 2.6 to 93 mg/l for the constituents. The water solubility is > 10 mg/l for 92% of the constituent composition including the main constituent D-limonene.
The log Kow of the constituents ranges from 4.27 – 4.88. It is below 4.5 for typically 74% of the constituent composition. With log Kow 4.38, D-limonene represents the group with a relatively high log Kow (Koc of limonene estimated at 2413). Log Kow is above 4.0 for 97% of the constituent composition. Most constituents may have a tendency to sorb to organic matter. As the NCS is considered to be biodegradable, adsorption/desorption studies were waived.
The estimated vapour pressure of Mandarin oil is 208.7 Pa, ranging from 133 to 655 Pa for the constituents. For D-Limonene (typically 70% of the composition) the vapour pressure is 193 Pa and another 6% of the constituents composition has a higher vapour pressure. This indicates that partitioning by volatilisation will be significant.
Classification and PBT assessment
Although Mandarin oil is considered readily biodegradable, log Kow is >4 for typically 97% of the constituent composition. As there is no empirical BCF for Mandarin oil or for its main constituent D-limonene at the moment, a classification for long-term effects in the environment applies as a worst case for both the classification according to Directive 67/548/EEC (DSD) and according to Regulation 1272/2008/EC (CLP).
Mandarin oil does not meet the PBT criteria: None of the constituents meets the Persistency criterion and they can therefore not be considered as PBT.
As typically 74% of the constituent composition has a log Kow <4.5, Mandarin oil is also not considered bioaccumulative. Mandarin oil is not to be considered as a PBT substance.
(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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