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EC number: 245-423-3 | CAS number: 23089-26-1
- 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
Description of key information
The LD50 of Candeia Oil after oral administration was found to be > 2000 mg/kg bw for male and female rats (reference 7.2.1 -1). Candeia Oil (source substance), which is a plant extract containing (+/-)-α-Bisabolol as main constituent, is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance). Therefore, it can be assumed that the LD50 of (-)-α-Bisabolol is also > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The test item is Candeia Oil, which is a plant extract containing α-Bisabolol as main constituent. Studies on acute oral toxicity were not performed for the target substance (-)-α-Bisabolol due to availability of reliable experimental data for Candeia Oil and (+/-)-α-Bisabolol. Candeia Oil and (+/-)-α-Bisabolol are considered to be suitable read across substances.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance Candeia Oil, CAS 515-69-5, which was used in the acute oral toxicity, had a purity of 85.4%. No information on impurities is available. The target substance (-)-α-Bisabolol, CAS 23089-26-1, is a main constituent of the tested Candeia Oil.
3. ANALOGUE APPROACH JUSTIFICATION
Experimental data i.e. acute oral toxicity studies in the rat were available for Candeia Oil and (+/-)-α-Bisabolol. Candeia Oil was tested in an acute oral toxicity study according to OECD 423 in Wistar rats. This study revealed a LD50 of > 2000 mg/kg bw. This result was supported by an acute oral toxicity study with (+/-)-α-Bisabolol in Sprague-Dawley rats. In this study the LD50 was determined to be > 5000 mg/kg bw. The information given on Candeia Oil and (+/-)-α-Bisabolol is considered to be sufficient to cover the required endpoint information for the target substance (-)-α-Bisabolol. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity study (reference 7.2.1-1)
A study was performed with Candeia Oil (source substance) according to OECD guideline 423 to assess the acute toxicity following oral administration in Wistar rats. Single doses of 2000 mg/kg bw of test material preparations in olive oil (Ph. Eur./DAB) were given to two dose groups of three fasted animals, each (males and females) by gavage in a sequential manner. No mortality occurred. No clinical signs and findings were observed. The mean body weights of the dose groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period. Under the conditions of this study the LD50 of the test substance after oral administration was found to be > 2000 mg/kg bw for male and female rats.
Candeia Oil (source substance), which is a plant extract containing (+/-)-α-Bisabolol as main constituent, is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance).
Acute oral toxicity study (reference 7.2.1 -2)
A study was performed with (+/-)-α-Bisabolol (source substance) to assess the acute oral toxicity to the rat. The test was performed with 5 male and 5 female rats per dose group. The test substance was formulated in 0.5% aqueous carboxymethyl cellulose formulation with 1 - 2 drops of Cremophor EL, at a dose level of 2150 and 5000 mg/kg bw. After administration a 14 day observation period followed. No mortality occurred. No effects on the body weight were observed. At the highest dose group (5000 mg/kg bw) the animals showed dyspnea, apathy, ruffled fur and a poor general state. The LD50 value was determined to be > 5000 mg/kg bw.
(+/-)-α-Bisabolol (source substance) is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance).
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered not to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.
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