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EC number: 294-954-7 | CAS number: 91771-61-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cymbopogon winterianus, Gramineae.
- 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:
- 27 August 2015 to 22 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, performed in accordance with OECD Guideline 420
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- statement of compliance presented
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Citronella oil (Cymbopogon winterianus, ext.)
- IUPAC Name:
- Citronella oil (Cymbopogon winterianus, ext.)
- Reference substance name:
- 91771-61-8
- Cas Number:
- 91771-61-8
- IUPAC Name:
- 91771-61-8
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Citronella oil (Cymbopogon winterianus, ext.)
- Physical state: liquid (pale yellow)
- Analytical purity: 100%
-Storage conditions: approximately 4 °C in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Fasting period before study: overnight fast before dosing and for 3-4 hours after dosing
- Housing: in groups, up to four animals, suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum, 2014C Teklad Global Rodent diet
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- BP; only at 300 mg/kg bw
- Details on oral exposure:
- The veicle was used only with the 300 mg/kg bw dose. At the high dose level of 2000 mg/kg bw the test item was supplied as such.
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: the test substance did not dissolve or suspend in water
- Rationale for the selection of the starting dose: no toxicity data available and hence, 300 mg/kg bw/d was chosen as a starting point. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals at 300 and 1 animal at 2000 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations : 30 min, 1, 2, & 4 h after dosing and then daily for up to 14 days
- Body weight recording: at Day 0 (after dosing), Day 7 and 14
- Morbidity/mortality: twice daily
- Necropsy of survivors performed: yes, external examination and opening of the abdominal and thoracic cavities
- Other examinations performed: no - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- Animal tested with 2000 mg/kg bw: hunched posture, increased respiratory rate, labored respiration, ataxia, lethargy, pallor of the extremities, hypothermia and pilo-erection. The animal was humanely killed due to signs of severe enduring.
Gross necropsy: Patchy pallor of the liver and epithelial sloughing of the gastric mucosa
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality seen at the dose level of 300 mg/kg bw.
- Clinical signs:
- other: No signs of toxicity were observed.
- Gross pathology:
- No adverse effects detected.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of Citronella oil (Cymbopogon winterianus, ext.) was determined to be between 300 and 2000 mg/kg bw, under the conditions of this test. The test substance is considered as harmful if swallowed (CLP criteria, Acute Tox. 4, H302).
- Executive summary:
In an acute oral fixed dose toxicity study, performed according to OECD 420, female Wistar rats were administered Citronella oil (Cymbopogon winterianus, ext.) by gavage. In this stepwise approach, an initial test was performed with the dose levels of 300 mg/kg bw in arachis oil and 2000 mg/kg bw as such (no vehicle) administered to single animals. The results lead to an additional group of four animals treated with a single dose of 300 mg/kg bwin arachis oil, followed by a 14-day observation period. Mortality, clinical signs of toxicity and body weights were recorded. Necropsy was performed in all animals.
Treatment with 2000 mg/kg bw induced toxicity, such as hunched posture, increased respiratory rate, labored respiration, ataxia, lethargy, pallor of the extremities, hypothermia and pilo-erection;the animal was humanely killed. No deaths or clinical signs of toxicity were seen at the dose level of 300 mg/kg bw. Body weights appeared unaffected by the treatment. Patchy pallor of the liver and epithelial sloughing of the gastric mucosa were detected at necropsy of the animal treated with 2000 mg/kg bw, while no abnormalities were seen in any of the animals treated with the lower dose. The oral LD50 was considered to be between 300 and 2000 mg/kg bw.The test item needs be classified according to the CLP 1272/2008/EC criteria, as harmful if swallowed, Acute Tox.4, H302.
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