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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
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA on 07/07/10 & 08/04/10
- Age at study initiation: The animals were born on 03/13/10 & 04/17/10. Study Initiation on 08/24/10
- Weight at study initiation: The pretest body weight range was 2.4 - 3.2 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended 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) was provided daily.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS: 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.
IN-LIFE DATES: From: 8/24/10 To: 8/27/10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Contralateral, untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat - Duration of treatment / exposure:
- The test article (0.1 ml) was placed by syringe into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test article. One eye of each rabbit was dosed. The contralateral eye served as a control.
- Observation period (in vivo):
- Type and Frequency of Observations
The treated and control eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in scoring. Sodium fluorescein dye procedures were used at the 24-hour observation interval in the treated eyes. The eyes were examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique.
Body weights were recorded pretest.
Observations for mortality, toxicity and pharmacological effects were recorded at each ocular observation period. All animals were humanely sacrificed using CO2 following study termination. - Number of animals or in vitro replicates:
- Three rabbits (males), free from evidence of ocular irritation or abnormalities, were assigned to this study without conscious bias. Prior to being selected for this study, both eyes of each animal were examined for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in the examination. Only animals in apparent good health were made available for study assignment.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No removal
SCORING SYSTEM: Ocular reactions were graded according to the numerical Draize technique, summarized below.
SCALE FOR SCORING OCULAR LESIONS (Draize, J. H. et al. J. Pharm. Exp. Ther. 82:377-390, 1944).
(1) CORNEA:
(A) Opacity: Degree of density (area most dense taken for reading):
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster),details of iris clearly visible 1(*)
Easily discernible translucent area, details of iris slightly obscured 2(*)
Opalescent areas, no details of iris visible, size of pupil barely discernible 3(*)
Opaque cornea, iris not discernible through the opacity 4(*)
(B) Area of cornea Involved:
One quarter (or less) but not zero 1
Greater than one-quarter, but less than one-half 2
Greater than one-half, but less than three-quarters 3
Greater than three quarters up to whole area 4
SCORE EQUALS A x B x 5 Maximum Total 80
(2) IRIS:
(A) Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination
of any thereof), iris still reacting to light (sluggish reaction is positive) 1(*)
No reaction to light, hemorrhage, gross destruction (any or all of these) 2(*)
SCORE EQUALS A x 5 Maximum Total 10
(3) CONJUNCTIVAE:
(A) REDNESS (refers to palpebral and bulbar conjunctivae excluding cornea & iris):
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2(*)
Diffuse beefy red 3(*)
(B) CHEMOSIS
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2(*)
Swelling with lids about half closed 3(*)
Swelling with lids more than half closed 4(*)
(C) DISCHARGE
No Discharge 0
Any amount different from normal (does not include small amounts observed in
inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs and considerable area around the eye 3
SCORE EQUALS (A+B+C)x2 Maximum Total 20
The maximum total score is the sum of all scores obtained for the cornea, iris and conjunctivae.
4.
(*)Indicates a positive response
ULTRAVIOLET FLUORESCEIN SCAN SCORING CODE:
0 = Negative
1 = Positive with an area 1/4 or less
2 = Positive with an area >1/4 but <1/2
3 = Positive with an area >1/2, but <3/4
4 = Positive with an area >3/4, up to entire area
TOOL USED TO ASSESS SCORE: To screen for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva prior to start of test, A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in scoring. The treated and control eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in scoring. Sodium fluorescein dye procedures were used at the 24-hour observation interval in the treated eyes. The eyes were examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean of animals 1, 2, & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: Mean of animals 1, 2, & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: Mean of animals 1, 2, & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean of animals 1, 2, & 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, and 72 hours
- Score:
- 0
- Remarks on result:
- other: See "any other information on results incl. tables" for complete data summary
- Irritant / corrosive response data:
- There was no corneal opacity, iritis or conjunctival irritation noted at any observation period.
The control eyes appeared normal at all observation periods.
Systemic Observations: There were no abnormal physical signs noted during the observation period. - Other effects:
- None observed
Any other information on results incl. tables
Ocular Findings, Systemic Observations, and Body Weights
Animal/Sex |
Item |
Tissue |
Reading |
1 hour |
24 hour |
48 hour |
72 hour |
H3492/M |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
|
B |
Area |
0 |
0 |
0 |
0 |
|
|
1. |
0 |
0 |
0 |
0 |
||
|
C |
Iris |
|
0 |
0 |
0 |
0 |
|
2. = (C x 5) |
|
0 |
0 |
0 |
0 |
|
|
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
|
Chemosis |
0 |
0 |
0 |
0 |
|
F |
|
Discharge |
0 |
0 |
0 |
0 |
|
3. |
|
0 |
0 |
0 |
0 |
|
|
Total 1 + 2+ 3 |
|
0 |
0 |
0 |
0 |
|
|
Systemic Observations |
|
A |
A |
A |
A |
|
|
Sodium Fluorescein |
|
|
0 |
NA |
NA |
|
|
Pretest Body Weight : 3.2 Kg |
|
|
|
|
||
------------- |
------------- |
------------- |
------------- |
------------ |
------------ |
------------ |
----------- |
Animal/Sex |
Item |
Tissue |
Reading |
1 hour |
24 hour |
48 hour |
72 hour |
H3555/M |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
|
B |
|
Area |
0 |
0 |
0 |
0 |
|
1. |
0 |
0 |
0 |
0 |
||
|
C |
Iris |
|
0 |
0 |
0 |
0 |
|
2. = (C x 5) |
|
0 |
0 |
0 |
0 |
|
|
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
|
Chemosis |
0 |
0 |
0 |
0 |
|
F |
|
Discharge |
0 |
0 |
0 |
0 |
|
3. |
0 |
0 |
0 |
0 |
|
|
|
Total 1 + 2+ 3 |
|
0 |
0 |
0 |
0 |
|
|
Systemic Observations |
|
A |
A |
A |
A |
|
|
Sodium Fluorescein |
|
|
0 |
NA |
NA |
|
|
Pretest Body Weight : 2.4 Kg |
|
|
|
|
||
------------- |
------------- |
------------- |
------------- |
------------ |
------------ |
------------ |
----------- |
Animal/Sex |
Item |
Tissue |
Reading |
1 hour |
24 hour |
48 hour |
72 hour |
H3539/M |
A |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
|
B |
|
Area |
0 |
0 |
0 |
0 |
|
1. |
|
0 |
0 |
|
|
|
|
C |
Iris |
|
0 |
0 |
0 |
0 |
|
2. = (C x 5) |
|
0 |
0 |
0 |
0 |
|
|
D |
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
|
E |
|
Chemosis |
0 |
0 |
0 |
0 |
|
F |
|
Discharge |
0 |
0 |
0 |
0 |
|
3. |
|
0 |
0 |
0 |
0 |
|
|
Total 1 + 2+ 3 |
|
0 |
0 |
0 |
0 |
|
|
Systemic Observations |
|
A |
A |
A |
A |
|
|
Sodium Fluorescein |
|
|
0 |
NA |
NA |
|
|
Pretest Body Weight : 2.5 Kg |
|
|
|
|
A = Normal; NA = Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Ocular administration of Farnesane CAS# 3891-98-3 did not produce irritation.
- Executive summary:
Objective: To determine the irritant and/or corrosive effects, if any, of a test article when instilled into the rabbit eye. This study was designed to comply with the standards set forth in EPA Health Effects Testing Guidelines, OPPTS Series 870.2400, final guideline, August 1998.
Method Synopsis: Three healthy New Zealand White rabbits (males), free from evidence of ocular irritation and corneal abnormalities, were dosed with Farnesane CAS# 3891-98-3. The test article (0.1 ml) was placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as a control. The eyes were examined and scored by the Draize technique at 1,24, 48 and 72 hours. The control eyes were examined at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. Observations for mortality, toxicity and pharmacological effects were recorded at each ocular observation period. Body weights were recorded pretest.
Summary:
There was no corneal opacity, iritis or conjunctival irritation noted at any observation period.
The control eyes appeared normal at all observation periods.
There were no abnormal physical signs noted during the observation period.
Conclusion: Ocular administration of Farnesane CAS# 3891-98-3 did not produce irritation.
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