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EC number: 297-672-2 | CAS number: 93686-22-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus reticulata, x C. sinensis, 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
Acute dermal toxicity (similar to OECD TG 402): 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:
- October 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substance Act (FHSA)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sherman-Wistar (albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: 24 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- no data available
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology - Statistics:
- no data
- Preliminary study:
- not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Mortality:
- 0/10
- Clinical signs:
- other: Diuresis, mild depressant effects noted one-half hour after dosing. Two females exhibited signs of morbidity; however, recovery was complete the following day.
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Tangerine oil in rats was > 5000 g/kg bw under the conditions of this test.
- Executive summary:
An acute oral toxicity study was performed by administering 5000 mg/kg bw of the test substance directly into the stomach of five male and five female albino rats. During a fourteen day observation period, no deaths occured. The LD50 of Tangerine oil is > 5000 mg/kg bw under the conditions of this test. Therefore, the test substance does not need to be classified accoring to the EU classification criteria outlined in the CLP Regulation (1272/2008/EC).
Reference
Dosage level (g/kg) | No. Rats Dosed | day 1 | day 2 | day 3 | day 4 | day 5 | day 6 | day 7 | day 8 | day 9 | day 10 | day 11 | day 12 | day 13 | day 14 | Mortality after 14 days |
5.0 | 5 males | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/5 |
5.0 | 5 females | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0/5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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:
- October 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
- Qualifier:
- according to guideline
- Guideline:
- other: Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol.26, No. 155, P. 7336, 12 August 1961
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- no data
- Duration of exposure:
- no data
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 6 (3 with intact skin, 3 with abraded skin)
- Control animals:
- not specified
- Details on study design:
- no data
- Statistics:
- no data
- Preliminary study:
- not applicable
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/6
- Clinical signs:
- other: In 3 animals, dry cracked skin was noted.
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of tangerine oil in rabbits was > 5000 mg/kg bw under the conditions of this test.
- Executive summary:
To determine the percutaneous toxicity of Tangerine oil, an acute dermal toxicity study was performed on six albino rabbits according to a method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, August 1961. The LD50 of the test substance was > 5000 mg/kg bw. Therefore, the test substance does not have to be classified according to the EU classification criteria outlined in the CLP Regulation (1272/2008/EC).
Reference
Dose (gram / kg) | No. Rabbits (Skin Intact) | Mortality | No. Rabbits (Skin Abraded) | Mortality |
5.0 | 3 | 0/3 | 3 | 0/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
For both acute oral and dermal toxicity, standard acute limit tests are available that are concisely reported. However, a consice description of the protocol is available and results are reported clearly, therefore the results of the study are acceptable as basic data.
In the acute oral toxicity study, Sherman-Wistar (albino) rats were exposed by gavage to a limit dose of 5000 mg/kg bw/day. No mortality was observed, therefore the LD50>5000 mg/kg.
In the acute dermal toxicity study rabbits were exposed to a limit dose of 5000 mg/kg bw/day. No mortality was observed, therefore the LD50>5000 mg/kg.
Justification for classification or non-classification
Based on the available information, tangerine oil has been shown to be of low acute toxicity when applied via the oral and dermal route. Therefore, the substance tangerine oil does not need to be classified for acute toxicity according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).
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