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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- 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:
- trans-beta-farnesene
CAS 18794-84-8
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: 4- 5 months
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: individually housed in suspended stainless steel wire bottom cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.05 – 21.94 °C
- Humidity (%): 1.3 – 25.1%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1/6/09 To: 1/9/09
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml/site; neat
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The test sites were scored for dermal irritation at 60 minutes after removal of wrappings. Reactions were
scored again at 24, 48 and 72 hours following patch removal - Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 4 ply surgical gauze patch. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semiocclusive manner and secured with non-irritating tape which completely covered the plastic. This method of wrapping aids in retaining the test patch in position and retards evaporation of volatile substances. The
test article was kept in contact with the skin for 4 hours at which time the wrappings were removed
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed from the test site by gently washing with distilled water
- Time after start of exposure: At the end of the exposure period, prior to scoring for dermal reactions.
SCORING SYSTEM:
Erythema & Eschar
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1.0 mm) 3
Severe edema (raised more than 1.0 mm, extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: Study ended at 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: Study ended at 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: Study ended at 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: Study ended at 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: Study ended at 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: Study ended at 72 hours
- Irritant / corrosive response data:
- Erythema was very slight to well defined at 60 minutes and well defined at 24, 48 and 72 hours following the 4 hour exposure. Edema was very slight to moderate at 60 minutes and slight at 24,48 and 72 hours following the 4 hour exposure.
Dermal Observations, Body Weights and Systemic Observations
Rabbit Eartag: H2035 H2017 H2077
Sex: F M M
Pretest Body Weight - kg: 3.0 2.9 2.7
Terminal Body Weight - kg: 2.9 2.9 2.6
Time after patch removal Erythema & Eschar Formation
60 minutes 1t 2t 1t
24 hours 2t 2t 2t
48 hours 2t 2t 2t
72 hours 2t 2t 2
Edema
60 minutes 2 3 1
24 hours 2 2 2
48 hours 2 2 2
72 hours 2 2 2
Systemic Observations
60 minutes A A A
24 hours A A A
48 hours A A A
72 hours A A A
A = Normal t = tape adhesive residue on dose site - Other effects:
- There were no abnormal physical signs noted during the observation period.
Two animals lost weight. All other body weight changes were normal.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not classified as skin irritant
- Executive summary:
Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (2 males - 1 female) were dosed dermally with trans-ß-farnesene, Lot# KJF-134-53-03, CAS# 18794-84-8. The test article (0.5 ml) was applied dermally to one intact site/rabbit and kept in contact with the skin for 4 hours at which time the wrappings were removed.
Dermal reactions were scored at 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest and at termination.
Erythema was very slight to well defined at 60 minutes and well defined at 24, 48 and 72 hours following the 4 hour exposure. Edema was very slight to moderate at 60 minutes and slight at 24, 48 and 72 hours following the 4 hour exposure. There were no abnormal physical signs noted during the observation period. Two animals lost weight. All other body weight changes were normal.
Dermal application of trans-ß-farnesene caused only mild skin reaction in rabbits following a 4hr semi-occlusive exposure. Skin reactions did not meet the criteria for classification as as a dermal irritant in accordance with EU CLP regulations.
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