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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 January 1990 - 12 February 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study performed similar to OECD guideline 404.
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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: 65°F - 85°F, store in well ventilated area
- Stability under test conditions: assumed stable for length of testing program
- Solubility and stability of the test substance in the solvent/vehicle: not applicable, the test article was tested neat
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was applied neat
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Horne Rabbitry, Kaysville, Utah
- Age at study initiation: no data (young Adult)
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: Animals were housed separately from any other species, individually housed in stainless steel, wire mesh bottom cages
- Diet (e.g. ad libitum): Fresh certified rabbit feed was provided -ad libitum
- Water (e.g. ad libitum): Fresh potable water was provided -ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61 - 70°F
- Humidity (%): 40 - 60%
- Air changes (per hr): not less than 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
NEGATIVE CONTROL
- Untreated
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL
- Concentration: 1% w/v aqueous solution - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: (1 x 1 inch)
- Type of wrap if used: the test and control articles were applied to the skin with a gauze patch which was securely taped in place with hypoallergenic tape. The patches were covered with an occlusive dressing consisting of an impervious, non-reactive plastic material and securely taped in place.
- approximately 24 hours prior to dermal administration, the hair was clipped from the dorsal and lateral areas of the animals.
REMOVAL OF TEST SUBSTANCE
- After 24 hours of exposure, the animals were unwrapped and the skin wiped with an absorbant pad to remove any remaining test article.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
- Mortality: twice daily on work days and at least once daily on all other days
- Clinical observations: at prescreen, approximately 25 hours after patch removal, 48 hours, 72 hours and days 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
- Body weight: within 48 hours of receipt and prior to dosing
SCORING SYSTEM:
- according to Draize
- Method of calculation: The primarv dermal irritation index (PDII) was calculated by summing the mean erythema score and the mean edema score from only the 25-, 48- and 72-hour observations.The PDII was calculated for the test material site, the positive control site, the untreated site and/or the moistening material control site . The PDII was then classified as follows:
PDII - 0.0 non irritant
> 0.0 - 0.5 negligible irritant
> 0.5 - 2.0 mild irritant
> 2.0 - 5.0 moderate irritant
> 5.0 - 8.0 severe irritant
Maximum possible calculated PDII equals 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 25/48/72
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- desquamation at test site from Day 4 to 14
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 25/48/72
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/48/72
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks:
- desquamation at test site from Day 4 to 14
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 25/48/72
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks:
- desquamation at the test site from Day 4 to Day 7
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 Days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 Days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 Days
- Remarks:
- desquamation at the test site from Days 4 to 9
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 Days
- Remarks:
- desquamation at the test site from Days 5 to 14
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- All of the animals were free of any dermal irritation at prescreen.
The untreated negative control sites remained free of any dermal irritation throughout the study period.
At the 25 hour scoring period, erythema and edema were exhibited at the test and positive control sites.
At the 48 hour scoring period, erythema and edema were exhibited at the test and positive control sites.
At the 72 hour scoring period, erythema and edema were exhibited at the test and positive control sites.
Dermal irritation was exhibited to some degree from day 4 to 14 at both the test and positive control sites. Desquamation was also noted at some of the test and positive control sites from day 4 to 14.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the average for the 25, 48 and 72 hour readings, the Primary Dermal Irritation Index was calculated to be 3.6; therefore, test article MIBKO was classified as a Moderate Irritant under the conditions of the test. Based on the criteria of the CLP regulation (EC) 1272/2008, the test item did not meet the criteria for classification.
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