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EC number: 203-298-2 | CAS number: 105-44-2
- 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:
- 1990-03-19 to 1990-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study performed similar to OECD Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- This study was conducted in accordance with the Good Laboratory Practice regulations as described by the FDA (21 CFR Part 58) and (40 CFR Parts 160 and 792).
Test material
- Reference substance name:
- 4-methylpentan-2-one oxime
- EC Number:
- 203-298-2
- EC Name:
- 4-methylpentan-2-one oxime
- Cas Number:
- 105-44-2
- Molecular formula:
- C6H13NO
- IUPAC Name:
- 4-methylpentan-2-one oxime
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 37905-27-4
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (65-85 °F)
- Stability under test conditions: Assumed stable for length of testing program
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable, 0.1 ml or 0.01 ml of neat test article
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: 4 male and 5 female New Zealand White rabbits; Sterling Rabbitry, Wellsville, Utah
- Age at study initiation: Young adults
- Weight at study initiation: 2.0 to 3.5 kg at initiation/ either sex.
- Housing: individually housed in stainless steel, wire mesh bottom cages.
- Diet (e.g. ad libitum): Fresh Certified Agway Rabbit Feed was provided -ad libitum.
- Water (e.g. ad libitum): Fresh potable water - ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 61-70°C
- Humidity (%): 40-60 %
- Air changes (per hr): not less than10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreaded and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Group I and II: 0.1 mL (right eye only); Group III: 0.01 mL (right eye only) - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals per group; 3 groups
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, for Group II rabbits only: the eyes were rinsed with room temperature tap water for appriximately one minute, using a volume (200 - 300 mL) and velocity of flow which could not cause injury.
- Time after start of exposure: approximately 20 seconds following administration of test article.
OBSERVATION TIME POINTS
- Body weights: within 48 hours of receipt and prior to dosing
- Ocular reaction (response of the cornea, iris and conjunctivae): at prescreen (approximately 1-2 hours prior to dosing), 1, 24, 48, 72 hours and on Days 4 and 7 after test substance application.
SCORING SYSTEM:
The ocular reaction was assessed according to the Draize Standard Eye Irritation Grading Scale.
TOOL USED TO ASSESS SCORE:
Eye examinations were made with biomicroscopic slit lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Group I
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- Group I
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- Group I
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Group I
- Basis:
- other: animal #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Group I
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Group I/redness
- Basis:
- other: animal #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Group I/redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Group I/discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Group I/discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Group I/discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Group I
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Group I
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Group I
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- At prescreen, all animals were found to be free of ocular lesions.
The untreated control eyes, of all animals, were free of ocular irritation throughout the study period.
Group I
Grade 1 corneal opacity in 2/3 test eyes, grade 1 iritis in 1/3 test eyes and signs of conjunctival irritation (grade 3 redness in 3/3 test eyes, grade 4 chemosis in 3/3 test eyes and grade 3 discharge in 3/3 test eyes) were observed at the 1 hour scoring interval. The corneal and iridial effects resolved by the day 4 scoring interval and the conjunctival irritation cleared by the day 7 scoring intervals.
Group II
Grade 1 corneal opacity in 2/3 test eyes and signs of conjunctival irritation (grade 3 redness in 3/3 test eyes, grades 2-4 chemosis in 3/3 test eyes and grade 3 discharge in 3/3 test eyes) were observed at the 1 hour scoring interval. The corneal effects resolved by the 72 hour scoring interval and the conjunctival irritation cleared by the day 4 scoring interval. Grade 1 iritis was noted in 1/3 test eyes at the 24 hour scoring interval and persisted until the day 4 scoring interval.
Group III
Grade 1 corneal opacity in 3/3 test eyes and conjunctival irritation (grade 3 redness in 3/3 test eyes, grades 2-3 chemosis in 3/3 test eyes and grade 3 discharge in 3/3 test eyes were observed at the 1 hour scoring interval. Both the corneal effects and the conjunctival irritation resolved by days 7 scoring interval.
Grade 1 iritis was noted in 3/3 test eye-s at the 24 hour scoring interval and persisted in 1/3 test eyes until the day 4 scoring interval.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based upon the classification scale of the study protocol, MIBKO (199-89B) (administered neat at a volume of 0.1 ml) is classified as a Moderate Irritant under both rinsed and unrinsed conditions. The test item is also classified as a Moderate Irritant when administered neat at a lower volume of 0.01 ml.
Based on the criteria of the CLP regulation (EC) 1272/2008, the test item should be classified for eye irritation category 2..
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