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EC number: 242-582-0 | CAS number: 18794-84-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was designed to comply with the standards set forth in EPA Health Effects Testing Guidelines, OPPTS Series 870.1100,December 2002 and in OECDGuidelines for the testing of Chemicals, Guideline 425 updated March 2006. The study was also conducted in accordance with Good Laboratory Practices requirements of EPA, 40 CFR 160 and 792, FDA 21 CFR 58, and the OECD, Principles on Good Laboratory Practices, 1997.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- (E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene
- EC Number:
- 242-582-0
- EC Name:
- (E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene
- Cas Number:
- 18794-84-8
- Molecular formula:
- C15H24
- IUPAC Name:
- (E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene
- Reference substance name:
- Farnesene
- IUPAC Name:
- Farnesene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): trans-beta-farnesene
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Wistar Albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals; Boyertown, Pennsylvanina USA
- Age at study initiation: 10 weeks
- Weight at study initiation: 209-218 grams
- Fasting period before study: 16-20 hours prior to dosing
- Housing: individually housed in suspended stainless steel wire bottom cages; paper bedding beneath cages with bedding changed 3x/week.
- Diet (e.g. ad libitum): PMI rat chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 24.38 °C
- Humidity (%): 0 - 3.6%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 12/30/2008 To: 1/19/2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg
- Rationale for the selection of the starting dose: Initially one animal was dosed. Since it survived, 2 additional animals were dosed. - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: pre-test, weekly, and at termination. Observation: Daily for toxicological effects and twice daily for mortality
- Necropsy of survivors performed: yes
- Other examinations performed: body weight and systemic toxicity
Results and discussion
- Preliminary study:
- First rat was dosed at 5000 mg/kg. No mortality so proceeded with dosing other rats with 5000 mg/kg
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 5 000
- Mortality:
- None observed
- Clinical signs:
- other: piloerection, wettness and staining about the urogenital area, alopecia, dark substance on nose.
- Gross pathology:
- No findings in necropsy
Systemic Observations
DOSE 5000 mg/kg
Animal # / Sex 1/F 2/F 3/F
15 minutes
Hour 1
Hour 2
Hour 4
Day 1 R T,F,1 T,F,1
Day 2 R T,1
Day 3 2
Day 4 2
Day 5 2
Day 6 2
Day 7 2
Day 8 2
Day 9 2
Day 10 2
Day 11 2 2
Day 12 2 2,3
Day 13 2 2,3
Day 14 2 2
No entry indicates animal appeared normal at that observation period.
F = Piloerection R = wetness of the anogenital area T = soiling of the anogenital area 1 = anogenital area stained yellowish around back tail area
2 = alopecia around anogenital area 3 = dark substance on nose
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Rat Oral LD50 > 5000 mg/kg
- Executive summary:
Initially, one healthy female Wistar albino rat was dosed orally with trans-ßfarnesene, (Lot# KJF-134-53-03, CAS# 18794-84-8) at 5000 mg/kg. Since the animal survived, two additional animals were dosed at 5000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. The potential for toxicity was based on the mortality response noted.
All three females survived the 5000 mg/kg oral dose. Instances of soiling, wetness and yellow staining of the anogenital area, piloerection, localized alopecia and chromorhinorrhea were noted during the observation period.
Body weight changes were normal in 2/3 animals. One animal lost weight during the second week of the observation period.
There were no macroscopic observations during terminal necropsy.
The LD50 of trans-ß-farnesene following oral administration to the rat was greater than 5000 mg/kg.
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