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EC number: 295-995-3 | CAS number: 92201-64-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Eucalyptus radiata australiana, Myrtaceae.
- 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
Oral
LD50 (mouse) = 3320 mg/kg bw (Ohsumi, 1984, Rel.4, WoE).
Dermal
Not required for Annex VII under REACH regulation.
Inhalation
Not required for Annex VII under REACH regulation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1984
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Original reference in Japanese language; data from English abstract and table only
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- LD50 determination in mice following gavage administration.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 18.0-22.0 g
- Fasting period before study: 20 h - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 0.1 mL/10 g - Doses:
- 2200, 2900 , 3700, 4800 and 6200 mg/kg bw
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- no
- Details on study design:
- - Toxic symptoms and changes in the body weight gain of the surviving mice were observed and the number of death was recorded for 7 days.
- Statistics:
- - LD50 with 95 % confidence limits was calculated with use of Litchfield-Wilcoxon's method.
- Preliminary study:
- Not applicable
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 320 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 770 - 3 980
- Mortality:
- Mortalities: 10, 20, 70, 90 and 100 % at 2200, 2900 , 3700, 4800 and 6200 mg/kg bw, respectively
- Clinical signs:
- other: Restraint of growth was observed in each surviving mouse.
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in mice therefore it is not classified according the CLP Regulation (EC) N° (1272/2008).
- Executive summary:
In an acute oral toxicity study, groups (10/dose) of male ddY mice were given a single oral dose of eucalyptus oil diluted in olive oil at 2200, 2900 , 3700, 4800 and 6200 mg/kg bw. Toxic symptoms and changes in the body weight gain of the surviving mice were observed and the number of death was recorded for 7 days.
Mortalities in male were 10, 20, 70, 90 and 100 % at 2200, 2900, 3700, 4800 and 6200 mg/kg bw, respectively. Restraint of growth was observed in each surviving mouse. The oral LD50 for eucalyptus oil was 3320 (2770-3980) mg/kg bw in male mice.
The oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in mice therefore it is not classified according to the CLP Regulation (EC) N° (1272/2008).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- LD50 determination in rats following gavage administration.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data, all rats came from the same litter
- Age at study initiation: no data
- Weight at study initiation: 100 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): Essentially consisted of oats, potato skins, bran and vegetables of all kinds, especially carrots. Then there were given appropriate doses vitamin D.
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
No data - Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on oral exposure:
- none
- Doses:
- no data
- No. of animals per sex per dose:
- 5 per group
- Control animals:
- yes
- Details on study design:
- none
- Statistics:
- no data
- Preliminary study:
- Not applicable
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 4 440 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No data
- Clinical signs:
- other: The animals near to death no longer feed themselves.
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50 = 4400 mg/kg bw.
- Executive summary:
In an acute oral test, 5 rats per dose were administered a single oral dose of Eucalyptus oil diluted in physiological saline by gavage. The oral LD50 was 4400 mg/kg bw.
As the oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° (1272/2008).
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 320 mg/kg bw
- Quality of whole database:
- Only basic data given in the two available studies, however results are consistent and were therefore considered sufficiently robust to cover this endpoint.
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
Oral
Ohsumi, 1984, RS, Rel. 4, WoE (Mouse)
In an acute oral toxicity study, groups (10/dose) of male ddY mice were given a single oral dose of eucalyptus oil diluted in olive oil at 2200, 2900 , 3700, 4800 and 6200 mg/kg bw. Toxic symptoms and changes in the body weight gain of the surviving mice were observed and the number of death was recorded for 7 days.
Mortalities in male were 10, 20, 70, 90 and 100 % at 2200, 2900, 3700, 4800 and 6200 mg/kg bw, respectively. Restraint of growth was observed in each surviving mouse. The oral LD50 for eucalyptus oil was 3320 (2770-3980) mg/kg bw in male mice. The oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in mice therefore it is not classified according to the CLP Regulation (EC) N° (1272/2008).
vonSkramlik, 1959, RS, Rel. 4, WoE (Rat)
In an acute oral test, 5 rats per dose were administered a single oral dose of Eucalyptus oil diluted in physiological saline by gavage. The oral LD50 was 4400 mg/kg bw.
As the oral LD50 for eucalyptus oil is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the CLP Regulation (EC) N° (1272/2008).
The two available studies were only poorly described but showed consistent results. Therefore a weight-of-evidence approach was followed for this endpoint. LD50 of 3320 mg/kg bw in mice and 4400 mg/kg bw in rats were reported by Oshumi and vonSkramlik, respectively. As a worst-case, the lowest LD50 value was selected as the key effect level for this endpoint.
Justification for classification or non-classification
Harmonized classification
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity (Oral)
Based on an available study on mice, the oral LD50 for the registered substance was 3320 mg/kg bw. As this oral LD50 is higher than 2000 mg/kg bw, the registered substance is not classified according to the Annex VI to the CLP Regulation (EC) N° (1272/2008). No signal word or hazard statement is required.
Acute toxicity (Dermal)
No data available (not required for annex VII under REACH regulation).
Acute toxicity (Inhalation)
No data available (not required for annex VII under REACH regulation).
Specific target organ toxicity: single exposure (Oral)
The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral).
No classification is required.
Specific target organ toxicity: single exposure (Dermal)
No data available.
Specific target organ toxicity: single exposure (Inhalation)
No data available.
Aspiration hazard
According to the typical concentrations, the registered substance has more than 10% of its constituents classified as Asp. Tox. 1 and should be classified as a Asp. Tox. 1 (H304: May be fatal if swallowed and enters airways) without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
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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