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EC number: 286-249-8 | CAS number: 85203-56-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Eucalyptus maculata citriodora, 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
Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD401)
Acute dermal toxicity: LD50 = 2480 mg/kg bw (similar to OECD402)
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:
- key study
- Study period:
- No data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to a guideline similar to OECD401 and in accordance with GLP. Materials and methods and results are reported clearly.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Hagan E.C., "Acute Toxicity", p17-25, 1975
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: licenced dealer, no details available
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: between 200 and 300 grams bodyweight
- Fasting period before study: 18 hours
- Housing: galvanized cages with indirect bedding
- Diet (e.g. ad libitum): growth and maintanance ration from commercial producer, ad libitum
- Water (e.g. ad libitum): ad libitium
- Acclimation period: at least 2 days prior to test initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled room
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ light cycle - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: no details available
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats (male)
5 rats (female) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1, 3, 9, 24 hours after treatment and daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: observed for signs of pharmacololgic activity and drug toxicity - Statistics:
- Not relevant
- Preliminary study:
- Not relevant
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 24 hours after treatment, mortality was observed in two males and one female (30% mortality rate).
- Gross pathology:
- Internal organs on superficial examination appeared normal
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 value of Eucalyptus Citriodora oil in rats was established to be >5000 mg/kg body weight. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
- Executive summary:
An acute oral toxicity test was performed according to methods similar to OECD401 and under GLP conditions. A single 5000 mg/kg bw dose of eucalyptus citriodora oil was administered by oral gavage to 5 male and 5 female Wistar albino rats. The animals were observed for signs of pharmacologic activity, drug toxicity and mortality on 1, 3, 9, 24 hours after treatment and daily thereafter for a total of 14 days. Mortality was observed 24 hours after treatment in two males and one female. Internal organs on superficial examination appeared normal.
24 hours after treatment, mortality was observed in two males and one female (30% mortality rate). Based on these results, the oral LD50 value of Eucalyptus Citriodora oil in rats was established to be >5000 mg/kg body weight. Therefore the substance does not need to be classified in accordance with the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 May - 15 June 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to methods similar to OECD guideline 402 and under GLP conditions. Test groups included only 3 animals of each sex and included animals with abraded skin.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- For each of four dose levels three male and three female rabbits were used and the skin of two males and one female was abraded
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: a suitably licensed dealer
- Age at study initiation: no data
- Weight at study initiation: 1.47 to 2.25 kg
- Fasting period before study: no data
- Housing: galvanized or stainless steel cages
- Diet: growth and maintenance ration from a commercial producer
- Water: ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: mid dorsal area of the trunk between the scapulae and pelvis
- % coverage: no data
- Type of wrap if used: impermeable plastic wrap fixed with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess test article was gently wiped off
- Time after start of exposure: 24 hours
TEST MATERIAL
- Single dermal application (volumetric dosing). - Duration of exposure:
- 24 hours
- Doses:
- 250, 1000, 2000, 3500 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation at 1, 3, 6, and 24 hours; once per day thereafter. Weighing on the day of dosing, after 14 days or upon death
- Necropsy of survivors performed: yes, animals sacrificed at the end of the 14 day observation period as well as non-survivors
- Other examinations performed: clinical signs - Preliminary study:
- Successive dose levels were chosen on the basis of the mortality observed at previously performed test level.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 480 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 530 - < 4 002
- Mortality:
- 250 mg/kg: none
1000 mg/kg: 1M
2000 mg/kg: 2M, 1F
3500 mg/kg: 2M, 1F - Clinical signs:
- other: 250 mg/kg: none 1000 mg/kg: none 2000 mg/kg after 24 hours: 1M, 1F slight depression, 1M severe depression 3500 mg/kg after 6 hours: 1M slight depression; after 24 hours: 1M; 1M, 2F slight depression
- Gross pathology:
- 250 mg/kg: none
1000 mg/kg: : 2M, 3F blanched skin; 1M faeces loose, 1M liver and lungs discoulered, 2F scab formed over test site, sloughing
2000 mg/kg: 2M, 2 F blanched skin; 1 M 1 F skin slightly reddened and swollen, blanched; 1M kidneys pitted; 1F yellow-white liver lesions, 0.2 - 0.3 cm, firm; 2F scab formed over test site, sloughing
3500 mg/kg: 2M 1F skin slightly reddened and swollen, blanched; 1M, 2F scab formed over test site, sloughing - Interpretation of results:
- not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of this study, the acute dermal LD50 in rabbits was calculated to be 2480 mg/kg bw. Based on this result, the test substance does not need to be classified in accordance with the criteria outlined in CLP (1272/2008/EC).
- Executive summary:
Acute dermal toxicity was tested in a test similar to OECD guideline 402. New Zealand white rabbits were acclimated for at least 6 days and dosed in groups of six (3M:3F) at 250, 1000, 2000 and 3500 mg/kg bw. The skin of half the animals (2M:1F) was abraded. Each animal received a single dermal application of the test substance. The test sites were occluded for 24 hours after which the wrap and remaining substance was removed. Animals were observed for clinical signs and mortality 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. All animals were subjected to gross necropsy.
Mortality was observed starting from the 1000 mg/kg bw dose group (1 animal). In the highest dose groups 3 animals of each group died. Clinical signs were only noted in the 2 highest dose groups and included slight and severe depression. Gross necropsy showed no effects in the lowest dose groups. From the 1000 mg/kg bw dose group effects on skin (blanching, reddening, swelling, scab formation) and some internal organs (liver and lungs discoloured, kidneys pitted, liver lesions) were observed.
Based on these results, the LD50 was calculated to be 2480 (CI: 1530 - 4020) mg/kg bw and therefore the test substance does not need to be classified in accordance with the criteria outlined in CLP (1272/2008/EC).
Reference
Draize scores:
- 250 mg/kg: all animals 1/1;
- 1000 mg/kg: 2/1, 0/0, 2/2, 1/1, 2/2, 2/1;
- 2000 mg/kg: 1/2, 1/2, 1/1, 1/1;
- 3500 mg/kg: 1/2, 1/1, 1/2
The LD50 can be considered as a 'worst-case' value since animals with abraded skin were included in the calculation. It is expected that the LD50 would have been higher when all animals would have been tested with intact skin.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 480 mg/kg bw
Additional information
Acute dermal toxicity
New Zealand white rabbits were dosed in groups of six (3M:3F) at 250, 1000, 2000 and 3500 mg/kg bw. The skin of half the animals (2M:1F) was abraded. Mortality was observed starting from the 1000 mg/kg bw dose group (1 animal). In the highest dose groups 3 animals of each group died. Based on these results, the LD50 was calculated to be 2480 (CI: 1530 - 4020) mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
The selected study is the key study for this endpoint.
Justification for selection of acute toxicity – dermal endpoint
The selected study is the key study for this endpoint.
Justification for classification or non-classification
Based on the available information, Eucalyptus Citriodora has shown to be non-toxic after oral exposure. Therefore, the substance does not need to be classified for Acute Oral Toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
Based on the available information, Eucalyptus Citriodora has shown to be non-toxic in contact with skin. Therefore, the substance does not need to be classified for Acute Dermal Toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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