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EC number: 622-542-2 | CAS number: 3891-98-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2,6,10-trimethyldodecane
- EC Number:
- 622-542-2
- Cas Number:
- 3891-98-3
- Molecular formula:
- C15H32
- IUPAC Name:
- 2,6,10-trimethyldodecane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Farnesane
- CAS number: 3891-98-3
-Specific Gravity: 0.77 g/cm3 at 15 °C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were received from Covance Research Products, Inc., Denver, PA on 08/11/10. Following an acclimation period of at least five days, five healthy male and five healthy, non-pregnant and nulliparous female New Zealand White rabbits were randomly assigned to the treatment group.
TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA
- Age at study initiation: The animals were born on 05/01/10. First Exposure was 8/18/10
- Weight at study initiation: The pretest body weight range was 2.1 - 2.9 kg for males and
2.2 - 2.5 kg for females. The weight variation of the animals used did not exceed + 20% of the mean weight.
- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages. Paper bedding was placed beneath the cages and changed at least three times/week. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days
IN-LIFE DATES: From: 8/18/10 To: 9/1/10
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Site Preparation
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact.
Dosing
A single dose of the test article was applied to the prepared site, over a 4-ply porous gauze dressing measuring 10 x 15 cm at a dose level of 5000 mg/kg. The dose was based on the sample weight as calculated from the specific gravity. The torso was wrapped with plastic sheeting in a semi-occlusive manner, which was secured with non-irritating tape. The test article remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was removed by gently washing with distilled water.
- Amount(s) applied (volume or weight with unit) are summarzed below in "Results and Discussion" table - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 males at 5000 mg/kg and 5 females at 5000 mg/kg
- Control animals:
- not required
- Details on study design:
- Five healthy male and five healthy female New Zealand White rabbits were dosed dermally with Farnesane CAS# 3891-98-3, Lot# AMD_072010 at 5000 mg/kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 24 hours postdose and on days 7 and 14. Animals were observed for toxicity, mortality and pharmacological effects at 1, 2 and 4 hours postdose and once daily for 14 days. Body weights were recorded pretest, weekly and at termination. All animals were examined for gross pathology.
- Statistics:
- Body weight data is summarized in "Results and Discussion"
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/10
- Clinical signs:
- other: One male and one female were noted with soiling of the anogenital area between days 1 and 3. There were no other abnormal physical signs noted during the observation period. Skin reactions were absent to well defined for erythema and absent to slight f
- Gross pathology:
- Necropsy results were normal.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Dermal LD50 in rabbits > 5000 mg/Kg
- Executive summary:
Objective: To determine the potential for toxicity of the test article when applied dermally. This study was designed to comply with the standards set forth in EPA Health Effects Testing Guidelines, OPPTS 870.1200, final guideline, August 1998.
Method Synopsis: Five healthy male and five healthy female New Zealand White rabbits were dosed dermally with farnesane CAS# 3891-98-3 at 5000 mg/Kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 24 hours post-dose and on days 7 and 14. Animals were observed for toxicity, mortality and pharmacological effects at 1, 2 and 4 hours postdose and once daily for 14 days. Body weights were recorded pretest, weekly and at termination. All animals were examined for gross pathology.
Summary: All animals survived the 5000 mg/Kg dermal application.
One male and one female were noted with soiling of the anogenital area between days 1 and 3. There were no other abnormal physical signs noted during the observation period.
Skin reactions were absent to well defined for erythema and absent to slight for edema at 24 hours. On day 7, flaking skin was noted in one animal and no other skin reactions were noted. On day 14, skin reactions were absent.
Body weight changes were normal.
Necropsy results were normal.
Conclusion: The dermal LD50 of Farnesane CAS# 3891-98-3 is greater than 5000 mg/Kg of body weight.
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