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EC number: 203-551-7 | CAS number: 108-11-2
- 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:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- - highest temperature recorded was 26 °C vs. 20 ± 3 °C range recommended
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - highest temperature recorded was 26 °C vs. 20 ± 3 °C range recommended
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylpentan-2-ol
- EC Number:
- 203-551-7
- EC Name:
- 4-methylpentan-2-ol
- Cas Number:
- 108-11-2
- Molecular formula:
- C6H14O
- IUPAC Name:
- 4-methylpentan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Methyl isobutyl carbinol; METHYL ISOBUTYL CARBINOL, 4-METHYL-2-PENTANOL, METHYL AMYL ALCOHOL.
- Physical state: Clear liquid.
- Analytical purity: 99.7%.
- Lot/batch No.: L-980710.
- Expiration date of the lot/batch: 10 July 1999.
- Stability under test conditions: Not reported.
- Storage condition of test material: Room temperature in the dark.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England.
- Age at study initiation: At least 11 weeks of age.
- Weight at study initiation: 2.3 to 2.9 kg.
- Housing: Housed individually in metal cages with perforated floors in Building R14 Room 4.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet), ad libitum. In addition, the animals were fed hay on arrival and subsequently three times a week.
- Water (e.g. ad libitum): Drinking water by Anglian Water, ad libitum.
- Acclimation period: A minimum period of 19 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 to 26 °C.
- Humidity (%): 41 to 68%.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 / 12.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL.
- Concentration (if solution): As supplied by the Sponsor. - Duration of treatment / exposure:
- After instillation of the test substance, the eyelid was gently held together for 1 second before releasing (single exposure).
- Observation period (in vivo):
- 1 hour and 1, 2, and 3 days after instillation. Additional observations were made 4.5 hours after instillation in 2 animals, 4 through 7 days after instillation in all 3 animals and 8 through 14 days after instillation in one animal.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.
SCORING SYSTEM:
Ocular opacity: degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffused areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
Area of corneal involved:
None: 0
One quarter (or less) but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
Iris:
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Conjunctivae Redness: (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal: 0
Some blood vessel definately hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
Chemosis: (lids and/or nictating membranes)
No swelling: 0
Any swelling above normal (includes nictating 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
Any other lesion not covered by this scoring system was described.
TOOL USED TO ASSESS SCORE: handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Dulling of the cornea observed 1 and 4.5 hours after instillation
- Irritation parameter:
- iris score
- Time point:
- other: Days 1 and 2
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Corneal opacification (Grade 1 or 2) developed in all 3 animals. Iridial inflammation (Grade 1) was observed in all 3 rabbits. A diffuse beefy red or crimson colouration of the conjunctivae and swelling with eyelids about half-closed was seen in all three animals. These reactions had resolved by either 7 or 14 days after instillation.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information CLP category 2 or R36 Criteria used for interpretation of results: EU
- Executive summary:
An eye irritation study on methyl iso butyl carbinol has been performed in accordance with OECD Guidelines for the Testing of Chemicals No. 405 and in compliance with GLP. In this study, 0.1 mL of undiluted methyl iso butyl carbinol was instilled into one conjunctival sac of each of 3 New Zealand White rabbits. Ocular changes were assessed 1, 4.5, 24, 48, 72 hours after treatment, and additional daily observations were made up to a maximum of 14 days. Eye irritation reactions were observed and scored according to guideline methods. No clinical signs of systemic toxicity or ill health were observed in any rabbit during the course of the study. Corneal opacification (Grade 1 or 2), iridial inflammation (Grade 1), and a diffuse beefy red or crimson coloration of the conjunctivae and swelling with eyelids about half-closed were observed in all animals. These effects were resolved within 7 or 14 days after instillation. Under the conditions of this study, methyl iso butyl carbinol induced corneal opacification, iridial inflammation, and conjunctival irritation. Individual mean scores over 24, 48 and 72 hours were 1.0, 0.7 and 2.0 for corneal opacity, 0.7, 0.7 and 0.3 for iritis, 2.3, 1.3 and 1.3 for conjunctival redness and 1.0, 0.3 and 0.3 for chemosis.
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