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EC number: 295-980-1 | CAS number: 92201-50-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cinnamomum camphora, Lauraceae.
- 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 toxicity, oral: LD50 = 5100 mg/kg bw (K, Rel.2).
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:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Standard acute method
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-300 g
- Housing: Animals were individually housed
- Diet: Commercial diets, ad libitum
- Water: Water, ad libitum
- Fasting period before study: Overnight fasting - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- 50 % (w/v or v/v)
- Doses:
- 1 to 6.81 mL/kg bw
- No. of animals per sex per dose:
- 2 animals for the preliminary study
5 animals for the main study (LD50 determination) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for toxic signs and mortality at 1 and 4 h and once daily thereafter for for 14 days.
- Necropsy performed: Yes; gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination and macroscopic examination was performed. - Statistics:
- - LD50 value was calculated according to Horn's method.
- Preliminary study:
- at 5000 mg/kg bw, 2/2 rats died.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 100 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 730 - < 7 470
- Mortality:
- No detail on the mortality in the main test
- Clinical signs:
- other: - Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia.
- Gross pathology:
- - At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract.
- No gross lesions were observed in animals killed at termination. - Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for Camphor oil is 5100 mg/kg bw (C.I. 2730-7470) in rats therefore the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study, a preliminary test was performed on two rats with a single dose of Camphor oil at 5000 mg/kg bw. Mortality was observed in 2/2 animals. Therefore the LD50 was determined in further animals (6 groups of 5 rats/dose). The rats were given a single oral dose of Camphor oil at 1 to 6.81 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.
Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia. At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract. No gross lesions were observed in animals killed at termination. In this study, the oral LD50 of test item was calculated to be 5100 mg/kg bw (C.I. 2730 -7470) in rats by the Horn's method.
Under the test conditions, the oral LD50 for Camphor oil is 5100 mg/kg bw (C.I. 2730 -7470) in rats therefore the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 100 mg/kg bw
- Quality of whole database:
- Basic data given, but considered sufficiently reliable for the purpose of hazard 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
Acute toxicity: via oral route:
A key study was identified (Wong, 1971, Rel. 2). In this acute oral toxicity study, a preliminary test was performed on two rats with a single dose of Camphor oil at 5000 mg/kg bw. Mortality was observed in 2/2 animals. Therefore the LD50 was determined in further animals (6 groups of 5 rats/dose). The rats were given a single oral dose of Camphor oil at 1 to 6.81 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.
Toxic signs observed were bloody crust eyes and nose, dyspnea, depression and ataxia. At ≥2.15 mL/kg bw, the dead rats had darkened lungs and gas and fluid in gastrointestinal tract. No gross lesions were observed in animals killed at termination. In this study, the oral LD50 of test item was calculated to be 5100 mg/kg bw (C.I. 2730 -7470) in rats by the Horn's method.
Justification for selection of acute toxicity – oral endpoint
Only one study available
Justification for classification or non-classification
Harmonized classification:
Camphor white oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Acute toxicity via Oral route:
Based on the available information, Camphor white oil is:
- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw
- not classified according to the Directive 67/548/EEC as the LD50 is greater than 2000 mg/kg bw.
Acute toxicity via Dermal route: This information is not available
Acute toxicity via Inhalation: This information is not available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Dermal): This information is not available
Specific target organ toxicity: single exposure (Inhalation): This information is not available.
Aspiration hazard :
Based on the typical composition provided by the Lead Registrant (> 10% of aspiration toxicants, i.e. limonene, pinene, myrcene, cymene-para), Camphor white oil should be classified for aspiration hazard category 1, H304 (May be fatal if swallowed and enters airways according to the regulation (EC) No. 1272/2008) according to CLP Regulation and GHS.
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