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EC number: 309-831-6 | CAS number: 101227-08-1
- 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
- Study period:
- 2005-02-15 until 2005-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-butyloctyl esters
- EC Number:
- 309-831-6
- EC Name:
- Fatty acids, C16-18, 2-butyloctyl esters
- Cas Number:
- 101227-08-1
- Molecular formula:
- C28H56O2 - C30H60O2
- IUPAC Name:
- Fatty acids, C16-18, 2-butyloctyl esters
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ISOFOL ESTER 1202, Fettsauren, C16-18, 2-Butyloctylester
- Substance type: Ester
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Little Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, 97633 Sulzfeld
- Age at study initiation: approx. 7 to 10 months
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: The study took place in animal rooms No. 5 and 8 provided with filtered air at a temperature of 20°C ± 3°C, relative humidity of 55 % ± 15 % and air changes 10 times/ hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 am to 6 pm.
- Diet (e.g. ad libitum): A pelleted complete rabbit diet "Altromin 2123" from Altromin, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for relevant possible contaminants are performed regularly.
- Acclimation period: at least 1 week, throughout the study the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10 times/ hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the test animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation with 20 ml 0.9 % sodium chloride solution
- Time after start of exposure: 24 h
SCORING SYSTEM:
Cornea:
Opacity: degree of density (readings should be taken frommost dense area):
Score 0: no ulceration or opacity
Score 1: scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible
Score 2:easily discernible translucent area; details of iris slightly obscured
Score 3: nacrous area; no details of iris visible; size of pupil barely discernible
Score 4: opaque cornea, iris is not dicernible through the opacity
Area of the cornea involved:
Score 1: One quarter (or less) but not zero.
Score 2:More than one quarter. but less than half.
Score 3: More than half, but less than three quarters.
Score 4: More than three quarters, up to whole area.
Iris:
Score 0: normal
Score 1: markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (sluggish reaction is considered to be an effect)
Score 2: hemorrhage, gross destruction, or no reaction to light
Conjunctiva: Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Score 0:normal
Score 1: some blood vessels hyperaemic (injected)
Score 2:diffuse, crimson colour; individual vessels not easily discernible
Score 3: diffuse beefy red
Chemosis: swelling (refers to lids and/or nictating membranes)
Score 0: normal
Score 1: sorne swelling above normal
Score 2: obvious swelling, with partial eversion of lids
Score 3: swelling, with lids about half closed
Score 4: swelling, with lids more than half closed
TOOL USED TO ASSESS SCORE: fluorescein, UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Eye irritating effects following a single instillation of 0.1 mL of Isofol Ester 1202 to rabbit eyes (grading according to OECD TG 405)
Animal |
Effect |
Score |
|||||
1 h |
24 h |
48 h |
72h |
Mean |
F |
||
1 |
Cornea |
1 (degree) 2 (area) |
0 0 |
0 0 |
0 |
0 |
- |
Iris |
0 |
0 |
0 |
0 |
0 |
- |
|
Conjunctivae Redness |
1 |
1 |
0 |
0 |
0.33 |
- |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
- |
|
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
Iris |
0 |
0 |
0 |
0 |
0 |
- |
|
Conjunctiva Redness |
1 |
1 |
0 |
0 |
0.33 |
- |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
- |
|
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
- |
Iris |
0 |
0 |
0 |
0 |
0 |
- |
|
Conjunctivae Redness |
1 |
1 |
0 |
0 |
0.33 |
- |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
- |
In general, the irritating effect of Isofol Ester 1202 on the rabbit eye was weak.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of the study described in the report and according to the directive of the EEC commission 2001/59/EC from August 6th, 2001 the test substance shall not be classified as eye irritating.
- Executive summary:
In a OECD 405 study, 0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each of 3 Little Russian rabbits for 24 hours. Eyes were washed with 20 ml 0.9 % sodium chloride solution at the end of the exposure period. Eye irritation was scored 1 h, 24 h, 48 h, 72 h after instillation of the test substance using the grading system of OECD test guideline 405 (Acute Eye Irritation/Corrosion).
One hour after the application of the test item animal No. 2928 showed scattered or diffuse opacity quarter the area of the cornea of the cornea on more than one quarter. Additionally some hyperaemic, conjunctival blood vessels were observed. Animals No. 3164 and No. 3163 showed some hyperaemic, conjunctival blood vessels only. 24 h. after the application of the test item animals No. 2928, No. 3164 and No. 3165 showed some hyperaemic, conjunctival blood vessels. 48 and 72 h. after the application of the test item animals No. 2928, No. 3164 and No. 3163 were free of any signs of eye irritation.
In this study, the test substance is not irritating to the eye according to EU regulations.
This study is assessed as acceptable. It satisfies the guideline requirements (OECD TG 405) for an acute eye irritation/corrosion study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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