Registration Dossier
Registration Dossier
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EC number: 290-335-0 | CAS number: 90131-24-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Spilanthes acmella, Compositae.
Endpoint summary
Administrative data
Description of key information
The substance belongs to a group of Natural Complex Substances (NCS): UVCB sub-type 3, where the source is biological and the process is refinement (See ECHA Guidance on Identification and naming of substances under REACH); such as: exudates, resinoids and concretes that are well-known to be very difficult to analytically assess. These complex UVCB substances contain a large number of constituents with different volatility and solubility (mostly low solubility); the composition can be widely unknown and being (mostly) solid(ish) and/or extremely viscous resins their physical state leads to further difficulties for testing.
Considering the very complex nature of the test item (UVCB, dark yellow viscous liquid, mainly composed of unknown constituents),physico-chemical properties of the registered substance were determined from experimental testing when possible. Some endpoints were waived, based on the experience in handling, testing and use of the substance and on the chemical structure of the known constituents. We also considered waiving based on the technical issues due to the complex nature of such UVCB substance especially when the information obtained from testing was not relevant or of practical use and irrelevant for subsequent assessments.No hazard was identified with regard to physical properties (flammability,explosivity, oxidising properties, self-heating substance) based on Regulation (EC) 1272/2008 (CLP regulation) andGHS.
No hazard was identified with regard to physical properties (flammability,explosivity, oxidising properties, self-heating substance) based on Regulation (EC) 1272/2008 (CLP regulation).
Additional information
Summary of relevant physico-chemical properties:
Endpoint (method) |
Data |
Appearance at 20°C and 1 atm.(visual observation) |
The test substance is a dark yellow viscous liquid at ambient temperature and atmospheric pressure. |
Melting/Freezing point (OECD 102/EU A1, DSC) |
Melting range: -72.9 °C to -17.6 °C. |
Boiling point (OECD 103/EU A2, DSC) |
The decomposition of the substance is determined at 267.1°C. No boiling point can be determined. |
Relative density (OECD 109/EU A3, pycnometer) |
The density of the test item has been determined to be 945.8 kg/m3 at 20.0 +/- 0.1°C. The relative density of the test item was determined to be D20/4 = 0.946. |
Granulometry (data waiving) |
Study scientifically not necessary (not granular / powder) |
Vapour pressure (OECD 104/EU A4, static method) |
The vapour pressure of the test item was calculated as 398 Pa at 20.0 °C and 510 Pa at 25 °C (interpolation). Note that the test item is a natural complex substance (NCS). It is a mixture of several constituents. The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents and these values may not represent the major part of the substance. |
log Kow (data waiving + QSAR estimation on knwon constituents) |
Waived based on technical issue and poor knownledge of the composition of the substance + QSAR estimation on known constituents of the registered substance. |
Water solubility (data waiving + QSAR estimation on knwon constituents) |
Waived considering the very complex nature of the test item, the information obtained from testing is considered as not relevant or of practical use for subsequent assessments. QSAR estimations on known constituents of the registered substance are also available. |
Surface tension (data waiving) |
Waived based on non-intended use of the substance (i.e. not a desired property). |
Auto-ignition temperature (EU A15/DIN51794) |
The auto-ignition temperature of the test item was 265°C. |
Flash-point ( EU A9, equilibrium method) Flammability (N.1 readily combustible solids) Flammability water&air (data waiving) Self-heating substances/mixtures (data waiving) |
The lowest flash point was observed at 95.0 °C using 4 ml ofthe substance. Test item is NOT classified as flammable liquid according to Regulation (EC) 1272/2008 (CLP regulation) and UN Globally Harmonised System (GHS). Note that the result obtained on this kind of substance should be largely influence by small amounts of volatile constituents and the result doesn't represent the major part of the substance. Waived based on the physical state (liquid) Waived based on experience in handling and use and chemical structure of known constituents of the substance. NOT flammable if contact with air or water NO self-heating substance anticipated. |
Explosive properties (data waiving) |
Waiving based on experience on this type of substance and chemical structure of known constituents. Low potential for explosive properties |
Oxidising properties (data waiving) |
Waiving based on technical issue and chemical structure of known constituents of the substance. Registered substance is considered to have low potential for oxidizing properties. |
Slight variations are possible with composition (UVCB substance).
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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