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EC number: 291-076-6 | CAS number: 90320-49-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Amyris balsamifera, Rutaceae.
- 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 (similar to OECD TG 401): LD50 >5000 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is a publication, that contains basic sufficient data for the assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- yes
- Remarks:
- Not all animals were of the same sex, no data on whether animals that died during the test were necropsied.
- GLP compliance:
- no
- Remarks:
- Not relevant
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adults
- Fasting period before study: 18 hrs
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Details on oral exposure: no data
- Doses: no data - No. of animals per sex per dose:
- 5 (per sex/per dose)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: two weeks
- Frequency of observations and weighing: no data ("close observation")
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: toxic signs and death - Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 580 mg/kg bw
- 95% CL:
- 1.5
- Mortality:
- Death time: 1-3 days
- Clinical signs:
- other: Toxic signs included ataxia, coma within 1 hr, porphyrinlike deposit around eyes and nose. Wet posterior
- Gross pathology:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of Amyris oil is 5580 mg/kg bw.
- Executive summary:
In this study, amyris oil was fed via intubation to 10 young rats (both male and female), which were fasted for approximately 18hr prior to treatment. All animals were monitored for toxic signs and time to death. The results show that the oral LD50 value of Amyris oil is 5580 mg/kg bw (95% confidence limit: 4540 -6860). The time to death was 1 -3 days. Toxic signs reported included ataxia, coma within 1 hr, porphyrinlike deposit around eyes and nose and wet posterior.
Based on the results obtained, it can be stated that in this study and under the experimental conditions reported, the test item Amyris oil does not need to be classified as acute toxic via oral exposure, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The study is a publication, that contains basic sufficient data for the assessment.
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
In this study, amyris oil was fed via intubation to 10 young rats (both male and female), which were fasted for approximately 18hr prior to treatment. All animals were monitored for toxic signs and time to death. The results show that the oral LD50 value of Amyris oil is 5580 mg/kg bw (95% confidence limit: 4540 -6860). The time to death was 1 -3 days. Toxic signs reported included ataxia, coma within 1 hr, porphyrinlike deposit around eyes and nose and wet posterior. Based on the results obtained, it can be stated that in this study and under the experimental conditions reported, the test item Amyris oil does not need to be classified as acute toxic via oral exposure, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
Justification for classification or non-classification
Based on the available data, Amyris oil does not need to be classified as acute toxic via oral exposure in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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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