Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-409-2 | CAS number: 1329-99-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Depanol I is considered to be absorbed by oral, inhalation and dermal route, however the oral route is most appropriate for testing. Deposition of Depanol I in the inhalation tract is not expected from its rather low vapour pressure, whereas repeated dermal administration is to be avoided due to its sensitizing properties. From one of the major components, d-limonene, it is known to be rapidly absorbed, metabolised and excreted, therefore there is no bioaccumulation potential. The various terpene hydrocarbons, which are known to be food flavor ingredients, have been described to be very similar from a kinetics and safety viewpoint.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 80
- Absorption rate - dermal (%):
- 80
- Absorption rate - inhalation (%):
- 80
Additional information
Depanol I is a colourless, neutral solvent with a terpene-like odour, low molecular weight (140.265), low water solubility (3.6- 5.9 mg/L) and has a Log Pow in the range of 4.75-4.88. Although the acute oral toxicity study did not show any findings, oral absorption is assumed to be relevant and the most appropriate route for testing. Based on the low vapour pressure (1.3 mm Hg or 230 Pa at 20°C ), deposition in the airways is considered to be very low to non-relevant, although the acute inhalation toxicity study showed some clinical observations. Finally, dermal absorption is possible as also calculated by Dermwin simulation, however as it is a sensitizer, it is not the preferable route of testing. For risk characterization, an absorption rate of 80% was considered for all routes from a conservative viewpoint.
Based on the low molecular weight and the high LogP of Depanol I, distribution is considered to be possible. This is confirmed by the presence of some CNS signs of toxicity during inhalation, although these findings may also have been due to discomfort. In general no relevant target organs for humans have been described in repeated-dose toxicity testing with (d-)limonene and other terpene hydrocarbons (components of Depanol I). There is no direct indication of bioaccumulation potential in mammalian species. There may be some accumulation in adipose tissue, but only in case of daily exposure. However this is not indicated from the repeated dose toxicity testing with d-limonene and other terpene hydrocarbons. Based on the rapid absorption, metabolic detoxification, and excretion in humans and other animals, bioaccumulation is not expected. Excretion has been well studied for d-limonene, where the metabolic pathway shows various water soluble metabolites. Several possible pathways of metabolism were described for d-Limonene, with differences between species. About 25–30% of an oral dose of d-limonene in humans was found in urine as d-limonene-8,9-diol and its glucuronide; about 7–11% was eliminated as perillic acid (4-(1- methylethenyl)-1-cyclohexene-1-carboxylic acid) and its metabolites. In another study, perillic acid was reported to be the principal metabolite in plasma in both rats and humans. Other reported pathways of limonene metabolism involve ring hydroxylation and oxidation of the methyl group. See more information in separate Toxicokinetics document attached to Section 13.
As Depanol I is composed of various terpene hydrocarbons, read across with the components or similar substances was applied. The monoterpene hydrocarbons are known to be ‘generally recognized as safe’ as flavor ingredients, which has recently been reaffirmed (GRASr). This was based on the knowledge of their rapid absorption and metabolic conversion, their wide safety margins and lack of genotoxic and mutagenic potential. The consistency of the results support the conclusion that terpene hydrocarbons in the food supply is not associated with significant risk to human health. Based on the safe profile, the similar properties between substances and the availability of extensive data, read across with some ‘typical’ examples was considered to be appropriate to fill the data gaps.
Data rich source compounds have been discussed in a
separated 'read across justification', including both aliphatic (mono-
and bicyclic) and aromatic terpene hydrocarbons. D-limonene can be used
as source chemical based on the similar structure, physicochemical and
toxicological findings. Various anchorpoints were available; confirming
validity as read across for the repeated and reproductive toxicity,
however for developmental toxicity data were still missing. Therefore a
second (aromatic) source chemical was selected, i.e. alfa-methylstyrene,
which also demonstrated a similar structure and similar
physicochemical and toxicological properties. Therefore, a many-to-one
read across approach was used for Depanol I. See more information in
separate Toxicokinetics document attached to Section 13.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.