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Registration Dossier
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EC number: 290-010-3 | CAS number: 90063-52-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantifolia, Rutaceae.
Endpoint summary
Administrative data
Description of key information
Substance characterisation
The test substance Lime oil is a Natural Complex Substance (NCS) which is a subgroup of Complex reaction products or Biological material (UVCB substances). With 99% of the constituent composition of Lime oil known, this NCS can be considered as a well defined NCS. The constituents of Lime oil are predominantly alicyclic unsaturated monoterpene hydrocarbons. Other constituents are alicyclic terpenoid hydrocarbons and acyclic monoterpene or terpenoid hydrocarbons. In the typical Lime oil (combined), the main constituent limonene is present at 44 %.
This composition represents a relatively homogenous type of NCS. The environmental risk assessment will be based on the properties of the main constituent 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 Lime 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), Lime oil is to be considered as a readily biodegradable substance. The water solubility ranges from 0.07 to over 500 mg/l for the constituents. The water solubility is > 10 mg/l for 82 % of the constituent composition including the main constituent limonene.
The log Kow of the constituents ranges from 3.1 to 7.1. It is below 4.5 for typically 72 % of the constituent composition, whereas for none of the constituents log Kow is below 3. Log Kow is above 4.0 for 83 % of the constituent composition.
Most constituents may have a tendency to sorb to organic matter. As the NCS is considered to be biodegradable, waivers were requested for the adsorption/desorption studies.
The estimated vapour pressure of Lime oil is 171 Pa, ranging from 2.6 * 10^-6 to 981 Pa for the constituents. For Limonene (typically 44 % of the composition) the vapour pressure is 193 Pa and another 22% of the constituent composition has a higher vapour pressure. This indicates that partitioning by volatilisation will be significant.
Classification and PBT assessment
Although Lime oil is considered readily biodegradable, log Kow is > 4 for typically 83% of the constituent composition. As there is no empirical BCF for Lime oil or for its main constituent 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).
Lime oil does not meet the PBT criteria: None of the constituents meets the Persistency criterion.
Typically 72% of the constituent composition has a log Kow < 4.5. The remaining 29% meets the screening criterion for bioaccumulative. However, as these constituents were shown to be readily biodegradable, Lime oil does not contain any constituents with PBT properties.
(1) A statement on the use of the protocol for Registration of Natural Complex Substance (NCS) under REACH has been attached to the dossier
Additional information
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