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EC number: 915-335-6 | CAS number: -
- 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:
- 20 April 1983 to 27 April 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate
- EC Number:
- 915-335-6
- Molecular formula:
- C11H20O2 C10H20O
- IUPAC Name:
- Reaction Mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2-3 kg
- Housing: housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne Rabbit Ration, checked daily and added or replaced, ad libitum
- Water: tap water, in 16 ounce glass bottles with sipper tubes or an automatic watering system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 April 1983, To: 27 April 1983
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each rabbit served as control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- METHOD
- Twenty-four hours prior to the application of the test material, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing pre-existing corneal injury were eliminated from the study. The test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of the test material. The contralateral eye remained untreated and served as a control.
- The eyes were examined at 1, 24, 48 and 72 hours and 7 days after treatment. The grades of ocular reaction (Table 1) were recorded at each examination. Grading of irritation is according to the method of Draize.
- An animal exhibited a positive reaction when the test substance produced one or more of the following signs: ulceration of the cornea (other than a fine stippling), opacity of the cornea (other than a slight dulling of the normal luster), inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels), or an obvious swelling in the conjunctivae (excluding the cornea and iris) with a partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1 and 4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2, 3, 5, and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 3, and 5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal: 2, 4, and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 and 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 and 4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3 and 5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Individual animal irritation scoring data can be found in table 2. Positive ocular responses were recorded at the 1, 24, 48 and 72 hour observation periods. No positive ocular responses were recorded on Day 7 at which time the study was terminated.
Any other information on results incl. tables
Table 2: The primary eye irritation data for individual animals and observation times is summarized in the following table.
Rabbit | Cornea | Iris | Conjunctivae | Total | |||||||
Number | Hr/Day | A (Opacity) | B (Area) | (A x B x 5) | A | A X 5 | A (Redness) | B (Chemosis) | C (Discharge) | (A + B + C) x 2 | Score |
3118 | 1 hours | 0 | 0 | 0 | 1 | 5 | 2 | 2 | 1 | 10 | 15 |
male | 24 hours | 1 | 4 | 20 | 1 | 5 | 2 | 2 | 3 | 14 | 39 |
48 hours | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 0 | 4 | 24 | |
72 hours | 1 | 4 | 20 | 0 | 0 | 0 | 1 | 1 | 4 | 24 | |
day 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean= | 0.60 | 2.40 | 0.40 | 1.00 | 1.20 | 1.00 | |||||
Mean | (24,48 and 72 hr) | 1.00 | 4.00 | 0.33 | 1.00 | 1.33 | 1.33 | ||||
3119 | 1 hours | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 8 | 8 |
male | 24 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
day 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean= | 0.00 | 0.00 | 0.00 | 0.40 | 0.20 | 0.40 | |||||
Mean | (24,48 and 72 hr) | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.33 | ||||
3120 | 1 hours | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 |
male | 24 hours | 0 | 0 | 0 | 1 | 5 | 2 | 1 | 1 | 8 | 13 |
48 hours | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
day 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean= | 0.00 | 0.00 | 0.20 | 0.80 | 0.20 | 0.40 | |||||
Mean | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 1.00 | 0.33 | 0.33 | ||||
3121 | 1 hours | 0 | 0 | 0 | 1 | 5 | 2 | 2 | 2 | 12 | 17 |
female | 24 hours | 1 | 4 | 20 | 0 | 0 | 3 | 2 | 1 | 12 | 32 |
48 hours | 1 | 4 | 20 | 0 | 0 | 2 | 1 | 1 | 8 | 28 | |
72 hours | 1 | 4 | 20 | 0 | 0 | 1 | 1 | 1 | 6 | 26 | |
day 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean= | 0.6 | 2.4 | 0.2 | 1.6 | 1.2 | 1 | |||||
Mean | (24,48 and 72 hr) | 1.00 | 4.00 | 0.00 | 2.00 | 1.33 | 1.00 | ||||
3122 | 1 hours | 0 | 0 | 0 | 1 | 5 | 1 | 1 | 1 | 6 | 11 |
female | 24 hours | 0 | 0 | 0 | 1 | 5 | 2 | 1 | 1 | 8 | 13 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
day 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean= | 0.00 | 0.00 | 0.40 | 0.60 | 0.40 | 0.40 | |||||
Mean | (24,48 and 72 hr) | 0.00 | 0.00 | 0.33 | 0.67 | 0.33 | 0.33 | ||||
3123 | 1 hours | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 4 | 4 |
female | 24 hours | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 |
48 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 hours | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
day 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean= | 0.00 | 0.00 | 0.00 | 0.40 | 0.00 | 0.20 | |||||
Mean | (24,48 and 72 hr) | 0.00 | 0.00 | 0.00 | 0.33 | 0.00 | 0.00 | ||||
Mean by sample time = | |||||||||||
1 hours | 0.00 | 0.00 | 0.50 | 1.50 | 1.00 | 1.17 | 9.83 | ||||
24 hours | 0.33 | 1.33 | 0.50 | 1.67 | 1.00 | 1.17 | 16.83 | ||||
48 hours | 0.33 | 1.33 | 0.00 | 0.67 | 0.33 | 0.17 | 9.00 | ||||
72 hours | 0.33 | 1.33 | 0.00 | 0.17 | 0.33 | 0.33 | 8.33 | ||||
day 7 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant
- Remarks:
- according to EU CLP (EC 1272/2008 and its amendments)
- Conclusions:
- An in vivo eye irritation test was conducted similar to OECD 405 and following GLP principles.
- Executive summary:
In an eye irritation study, performed similar to OECD 405 and following GLP principles, 0.1 mL of undiluted test substance was applied to six rabbit eyes followed by examinations at 24-, 48 and 72-hours and at day 7 days following treatment. The following results were obtained and expressed as mean scores 24, 48, and 72 hours after removal of the substance: Corneal opacity (score 1) was observed in 2 out of 6 animals. Iritis (Score 0.33) was observed in 3 out of 6 animals. Conjunctivae redness was observed in 5 out of 6 animals with scoring of 0.33, 0.67, 1 (2 animals), and 2, respectively. Chemosis was observed in 4 out of 6 animals with scoring of 0.33 (2 animals), and 1.33 (2 animals). All effects were cleared with 7 days.
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