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Diss Factsheets
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EC number: 946-913-6 | CAS number: -
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation
- EC Number:
- 946-913-6
- Molecular formula:
- Not applicable for UVCB Substance
- IUPAC Name:
- Essential oil of Copaiba obtained from the exudate of Copaifera (Fabaceae) trees by distillation
- Test material form:
- liquid
- Details on test material:
- For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Copaiba oil, Copiaba Balsam oil, Copaiba oleoresin
Constituent 1
- Specific details on test material used for the study:
- clear colorless liquid SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: research Institute for Fragrance Materials
-RIFM number: 56452
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-300 g
- Fasting period before study: overnight
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% (v/v)
- Justification for choice of vehicle: according to guideline - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: toxic signs and mortality were observed forllowing dosing at one and four hours, and once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
- Preliminary study:
- Two aninals were given a single dose by gastric intubation. No deaths occured, so 8 additional animals were given the samen dose via the same route.
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: Signs of diahrrea, depression and piloerection were observed.
- Gross pathology:
- No gross findings
Applicant's summary and conclusion
- Interpretation of results:
- other: not classied
- Remarks:
- based on CLP criteria (Annex I 1272/2008/EC)
- Conclusions:
- The oral LD50 value of Copaiba balsam oil in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified for acute oral toxicity according to the criteria laid down in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The acute toxic potential of Copaiba Balsam oil was assessed in an acute oral toxicity limit test performed in 10 rats. The rats were exposed to 5000 mg/kg bw Copaibla balsam oil via the oral route, and observed for clinical signs and mortality over an examination period of 14 days. Observations were performed at one and four hours and daily thereafter. At the end of the study period no mortality was observed in any of the animals. Symptoms observed in the test animals were diarrhea, depression, piloerection. No gross findings were noted. The LD50 for acute oral toxicity was set at >5000 mg/kg bw.
Based on these results Copaiba Balsam oil does not have to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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