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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Acute Toxicity: dermal
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation
- EC Number:
- 943-438-6
- Cas Number:
- 90063-59-5
- IUPAC Name:
- Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation
- Test material form:
- liquid
1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
- Preliminary study:
- Not relevant
Effect levels
- 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
Applicant's summary and conclusion
- 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).
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.