Registration Dossier
Registration Dossier
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EC number: 284-515-8 | CAS number: 84929-31-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus limonum, Rutaceae.
Endpoint summary
Administrative data
Description of key information
Additional information
Substance characterisation
The test substance Lemon oil is an NCS composed of a range of constituents: monoterpeneoids (typically 10%) and hydrocarbon terpenes (typically 87%). In the typical Lemon oil, the main constituent D-limonene is present at 60%. The composition with D-limonene and some minor constituents that are structurally related to D-limonene, represents a relatively homogenous type of NCS and the environmental risk assessment may be based on the properties of the main constituent D-limonene. The minor constituents have different properties for water solubility, volatility, adsorption and lipophility that determine their environmental behaviour. Due to these differences the assessment of the environmental properties of Lemon oil is preferably based on data for the 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), Lemon oil is to be considered as a readily biodegradable substance. The water solubility ranges from 0.5 to 1767 mg/l for the constituents. The water solubility is > 10 mg/l for 82% of the constituent composition including the main constituent D-limonene. For 17% of the remaining identified constituents the water solubility is around 3 mg/l and one constituent present in 1% has an estimated water solubility of 0.5 mg/l.
The log Kow of the constituents is above 4.0 for 91% of the constituent composition, none of the constituents have a log Kow below 3. With log Kow 4.38, limonene represents the group with a high log Kow (Koc of limonene estimated at 2413).
Most constituents will have a tendency to sorb to organic matter.
The estimated BCF of the constituents in Lemon oil was in the range of 66 to 250 for monoterpenoids, typically 10 % of Lemon oil, and 250 - 6683 for hydrocarbon terpenes, typically 87% of Lemon oil. With D-limonene as the main constituent the BCF is 361 for > 25% (typical 60%) of the NCS. The BCF is above 500 for only 3% (typical) of the NCS. As the constituents are readily biodegradable, it is likely that they will also be biotransformed in higher organisms so a high bioaccumulation factor is actually not expected.
The estimated vapour pressure of lemon oil was 218.8 Pa, ranging from 2.12 to 981 Pa for the constituents. For D-Limonene (typically 60%) the vapour pressure is 193 Pa and 19% of the constituents composition has a higher vapour pressure. This indicates that partitioning by volatilisation may play a role.
Classification and PBT assessment
Although Lemon oil is considered readily biodegradable, the log Kow is >4 for typically 91% of the constituents. As there is no tested BCF for Lemon oil or for its main constituent D-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).
Based on its ready biodegradability, Lemon oil does not fulfill the criteria for Persistent. As typically 83% of the components has a log Kow <4.5, Lemon oil is also not considered bioaccumulative.
(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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