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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: dermal
Administrative data
- 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.
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 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
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:
- 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
Administration / exposure
- 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
Results and discussion
- Preliminary study:
- No signs of systemic toxicity observed at any of the two animals treated during the initial test.
Effect levels
- 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
Applicant's summary and conclusion
- 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.
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