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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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: 300 >LD50< 2000 mg/kg bw (OECD 420)
Acute dermal toxicity: LD50> 2000 mg/kg bw (OECD 402)
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:
- 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
- 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
- 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 - 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
- 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 - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- The only study available, is a recent GLP, Guidance study and it is considered appropriate to be used as the basis for the chemical safety assessment.The LD50 was determined to be between the range of 300 and 2000 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:
- 09 September 2015 to 30 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, performed according to the OECD Guideline 402.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Initially, 1 animal/sex was given a single dose of 2000 mg/kg body weight. Based on the result, an additionalgroup of 8 animals was treated accordingly. This deviation does not compromise the result of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/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
- Weight at study initiation: at least 200 g
- Fasting period before study: overnight fast before dosing and for 3-4 hours after dosing
- Housing: indivudually during dosing and till 24 h post-treatment, in groups up to 4 animals of same sex rest of the experiment, 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 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure, % coverage: 10% of the total body surface area
- Type of wrap if used: semi-occlusive self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.26 mL/kg
- Constant volume or concentration used: yes
VEHICLE no vehicle used - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Initially, 2 animals (1 male, 1 female) were given a single dermal application of the test item at a dose level of 2000 mg/kg body weight. Based on the result, an additionalgroup of 8 animals was treated accordingly.
- 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 performed: yes, external examination and opening of the abdominal and thoracic cavities
- Other examinations performed: yes, irritation scoring assigned once per day for the whole observation period - Statistics:
- Not applicable
- Preliminary study:
- No signs of systemic toxicity observed at any of the two animals treated during the initial test.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was detected
- Clinical signs:
- other: No signs of toxicity observed at any the two animals treated
- Gross pathology:
- No abnormalities seen
- Other findings:
- - Other observations: no signs of dermal irritation
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of Citronella oil (Cymbopogon winterianus, ext.) was estimated to be higher than 2000 mg/kg bw, under the conditions of this test and hence, the test substance is practically non toxic.
- Executive summary:
In an acute dermal toxicity study, performed according to OECD 402, male and female Wistar rats were administered with a single dose of unchanged Citronella oil (Cymbopogon winterianus, ext.), for 24 h kept in place with a semi- occlusive dressing. An initial test was performed with one male and one female animal. The results lead to an additional group of four animals/sex treated with a single same dose of 2000 mg/kg bw, followed by a 14-day observation period. Mortality, clinical signs of toxicity and body weights were recorded. Irritation scorings were given. Necropsy was performed in all animals.
Treatment with the test item did not result in any deaths, clinical signs of toxicity or macroscopical abnormalitites. Transient body weight losses were recorded in two animals, but were deemed acceptable variations for the species tested. The dermal LD50 of the test substance was established to be higher than 2000 mg/kg bw, under the conditions of this test. The test shall not be classified for acute oral toxicity, as set down by the CLP 1272/2008/EC criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
One acute oral toxicity test is available for Citronella oil (C. winterianus ext.), in which the fixed dose procedure was applied Single doses: 300 and 2000 mg/kg bw were given by gavage to female Wistar rats. The LD50 was estimated to be in the range of 300 and 2000 mg/kg bw, due to severe toxicity and deliberate death at the highest administered dose.
Acute dermal toxicity was tested in a standard acute limit test, during which Citronella oil (C.winterianus ext.) was applied dermally for 24 h to the skin of 5 male and 5 female Wistar rats, at a dose of 2000 mg/kg bw. No mortality was noted, and hence, the dermal LD50 is considered higher than 2000 mg/kg bw.
Justification for classification or non-classification
The oral LD50 of Citronella oil (Cymbopogon winterianus, ext.) was found to be between 300 and 2000 mg/kg bw. Under the conditions of this test, the substance should be classified for acute oral toxicity (H302 / Acute Tox. 4) in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
The dermal LD50 was estimated to be higher than 2000 mg/kg bw. Under the conditions of this test, Citronella oil (Cymbopogon winterianus, ext.) does not need to be classified for acute dermal toxicity in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).
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