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EC number: 943-438-6 | CAS number: 90063-59-5
- 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 OECD 401)
Acute dermal toxicity: LD50 = 4800 mg/kg bw (similar to OECD 402)
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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test was conducted according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approximately 200 g
- Fasting period before study: 16-18 hrs
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology - Preliminary study:
- Not relevant
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was observed in one rat.
- Clinical signs:
- other: No effects observed
- Gross pathology:
- Necropsy performed: lungs red throughout in one rat
- Other findings:
- Not reported
- Interpretation of results:
- other: not classified
- Remarks:
- according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
- Conclusions:
- The oral LD50 value of Litsea Cubeba Oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. 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:
A single 5000 mg/kg bw dose of Litsea Cubeba oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No symptoms were noted. Mortality was observed in one rat. The oral LD50 value of Litsea Cubeba oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have 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).
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 3 November 1976 - 29 December 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD guideline 401 and was performed pre-GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (study was used for range-finding)
- GLP compliance:
- no
- Remarks:
- performed pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 1760, 4400 and 8800 mg/kg bw
- No. of animals per sex per dose:
- - 1760 mg/kg bw:: 1 animal per sex
- 4400 mg/kg bw:: 3 animals per sex
- 8800 mg/kg bw:: 1 animal per sex - Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 400 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 3 out of 6 animals died (all female)
- Interpretation of results:
- other: not classified
- Remarks:
- according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
- Conclusions:
- Under the conditions of this study, mice exposed to Litsea cubeba by oral gavage showed acute effects and mortality at the 4400 and 8800 mg/kg bw dose. Based on these results an LD50 of 4400 mg/kg bw was established. The substance therefore does not need to be classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
An acute oral toxicity according to similar methods as described in OECD guideline 401 was performed with test substance Litsea cubeba essential oil. Three doses (2, 5, 10 ml/kg bw) were administered by oral gavage to male and female mice (1, 3 and 1 animal(s)/sex, respectively). Clinical signs (incl. mortality) were noted and postmortem examinations were performed.
Animals of the two highest dose groups were hypothermic, somnolent or comatose, showing signs of stress and exhibiting laboured breathing within 30 minutes after treatment. Mice of the low dose group appeared unaffected by treatment. Mice of the highest dose group died within 2 and 18 hours after treatment. Three female mice dosed at 4400 mg/kg bw were dead within 18 hours, but the male mice at this dose level recovered within 42 hours. No mortality was observed in the lowest dose group.
Under the conditions of this study, mice exposed to Litsea cubeba essential oil by oral gavage showed acute effects and mortality at the 4400 and 8800 mg/kg bw dose. Based on these results an LD50 of 4400 mg/kg bw was established. The substance therefore does not need to be classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Referenceopen allclose all
Clinical signs: Animals of the two highest dose groups were hypothermic, somnolent or comatose, showing signs of stress and exhibiting laboured breathing within 30 minutes after treatment. Mice of the low dose group appeared unaffected by treatment.
Mortality: Mice of the highest dose group died within 2 and 18 hours after treatment. Three female mice dosed at 4400 mg/kg bw were dead within 18 hours after treatment, but the male mice at this dose level recovered within 42 hours. No mortality was observed in the lowest dose group.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The key study was conducted in rats according to methods similar to OECD guideline 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly. An adverse effect (mortality in 1 out of rats) was observed. However based on this result, no discriminating dose could be derived LD50 > 5000 mg/kg bw.
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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Test was conducted according to methods similar to OECD guideline 402 and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Approximately 2 kg
- Housing: 2 animals per cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS
-Temperature controlled room - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Abdominal area (skin was abraded)
- Type of wrap if used: 2 single layers of gauze and impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs - Duration of exposure:
- 24 hrs
- Doses:
- 1250, 2500, 5000 mg/kg bw
- No. of animals per sex per dose:
- Four animals per dose, with a total of 12 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology, skin irritation - Statistics:
- Not relevant
- Preliminary study:
- Not relevant
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 400 - 9 600
- Mortality:
- Mortality was observed in two out of four animals in the highest dose (5000 mg/kg bw) on the third and sixth day, and in one out of four animals on the fourth day in the 2500 mg/kg dose group.
- Clinical signs:
- other: For the two lowest dose groups no clinical signs were noted, while in the highest doser group anorexia, ptosis and ataxia were noted in 2 animals (not specified whether these were the same animals). In all rabbits and at all doses marked redness and moder
- Gross pathology:
- Necropsy:
- 2500 mg/kg bw: evidence of extreme diarrhea, extreme dermal and subdermal irritation in 1 animal
- 5000 mg/kg bw: liver blotchy in 1 animal, subdermal irritation in 1 animal, no visible lesion in 1 animal - Other findings:
- Not reported
- Interpretation of results:
- other: Not classified
- Remarks:
- according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
- Conclusions:
- Under the conditions of this study, dermal application of Litsea Cubeba oil induced mortality at a dose of 2500 mg/kg bw (1/4 animals) and at a dose of 5000 mg/kg bw (2/4 animals). The LD50 is established at 4800 mg/kg bw (CI: 2400-9600) and therefore the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
Three dose levels of Litsea Cubeba oil (1250, 2500, 5000 mg/kg bw) were applied dermally to the skin of 12 rabbits (4 per group). The rabbits were observed for 14 days thereafter for mortality and symptomatology (skin irritation).
No mortality was observed in the lowest dose group. In the 2500 mg/kg bw group, mortality was observed in 1 out of 4 animals. In the 5000 mg/kg bw group 2 out of 4 animals died. At the highest dose level, anorexia was observed in 2 animals, ptosis in 2 animals and ataxia in 2 animals. At 2500 mg/kg bw evidence of extreme diarrhea, extreme dermal and subdermal irritation in 1 animal were observed. At 5000 mg/kg bw a blotchy liver was observed in 1 animal, subdermal irritation in 1 animal and no visible lesions were observed in 1 animal.
Based on the conditions of this study, the LD50 was established to be 4800 mg/kg bw (confidence interval of 2400-9600 mg/kg bw) and therefore the substance does not need to be classified for acute dermal toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 800 mg/kg bw
- Quality of whole database:
- Test was conducted according to methods similar to OECD guideline 402 and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
Additional information
Acute oral toxicity
In the key study a single 5000 mg/kg bw dose of Litsea Cubeba oil was administered by oral gavage to 10 male Wistar rats. No symptoms were noted. Mortality was observed in one rat. The oral LD50 value of Litsea Cubeba oil in rats was established as exceeding 5000 mg/kg bw. This result is supported by another study (similar to OECD 401, performed in mice) in which an LD50 of 4400 mg/kg bw was established.
Acute dermal toxicity
In the key study three dose levels of Litsea Cubeba oil (1250, 2500, 5000 mg/kg bw) were applied dermally to the skin of 12 rabbits (4 per group). Mortality was observed in 1 out of 4 animals at a dose of 2500 mg/kg bw and in 2 out of 4 animals at a dose of 5000 mg/kg bw. No mortality occurred in the lowest dose group. Based on these results, the LD50 was established to be 4800 mg/kg bw (confidence interval of 2400-9600 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, Litsea cubeba oil 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, Lisea cubeba oil 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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