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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 November 1989 - 06 December 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
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 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The objective of the study was to assess the potential of MIBKO to elicit an allergic contact sensitization response in guinea pigs. The Local Lymph node Assay is recognized as the preferred test method. However, this in vivo guinea pig maximization test was performed prior to enforcement of the OECD guideline 429 ; and was deemed suited for skin sensitisation potential assessment of the test substance.
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:
- - Test article code Number: MIBKO (199-89B)
- Physical description: clear liquid
- Lot number: 37905-27-4
- Purity: 100%
- Physicochemical parameters: density 0.88 g/ml; solubility 0.9% in water
- Expiration date: No data
- Storage conditions: 65-85°F
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Laboratory Animals Wayne, New Jersey 07470 , USA
- Age at study initiation: Young adult
- Weight at study initiation: 275 - 425 g
- Housing: Individually housed in stainless steel, wire mesh bottom cages.
- Diet: ad libitum , Fresh Aqway Certified Guinea Pig - Feed was provided throuqhout both the acclimation and scudy periods.
- Water: ad libitum, via an automatic watering system
- Acclimatization period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 64 - 79 °C
- Humidity: 40 - 70 %
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 07 Nov 1989 To: 15 Dec 1989
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5.0% w/v
- Day(s)/duration:
- Day 1 of treatment
- Route:
- intradermal
- Vehicle:
- other: Freunds Complete Adjuvant (FCA) emulsion
- Concentration / amount:
- 5.0% w/v
- Day(s)/duration:
- Day 1 of treatment
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 100% w/v
- Day(s)/duration:
- Day 7 of treatment
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% w/v of test article for negative control and test animals
0.1% w/v of Dinitrochlorobenzene (DNCB) to positive control animals - Day(s)/duration:
- Day 21 of the study
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5% w/v of the test item to the negative control and test animals
- Day(s)/duration:
- Day 28 of the study
- No. of animals per dose:
- MIBKO
Intradermal Range Finding : 4 animals
Topical Range Finding : 8 animals
Induction/Challenge : 15 animals
Challenge control : 5 animals
Rechallenge control : 5 animals
DNCB
Induction/Challenge : 10 animals
Challenge Control : 5 animals
TOTAL: 52 animals - Details on study design:
- BODY WEIGHTS
Body weights were measured on Days -7, 0, 7, 14, 21 and 28 of the study for all animals used on the main study. Body weights for the range finding animals were measured on the day of dosing only.
INTRADERMAL RANGE FINDING TEST
Four w/v concentrations of the test article were prepared in Propylene Glycol and also in Freund's Complete Adjuvant (FCA) Emulsion (1:1 FCA in sterile water for injection, USP). The following concentrations were used: 0.1%, 1.0%, 3.0% and 5.0%. On the day of dosing, the hair was removed from the backs of four guinea pigs using a small animal clipper and a size No. 40 blade.
Two pair of intradermal injections at a volume of 0.1 ml each were made along the spine on each of the four guinea pigs (two injections per side)
Approximately 24 and 48 hours following injection, all sites were scored for erythema.
TOPICAL RANGE FINDING STUDIES
Four w/v concentrations of the test article were prepared in propylene glycol. A second topical range finding study was performed due to the irritating results noted following the first range finding study.
- No. of exposures: 1 (topical application)
- Type of epicutaneous induction: occlusive
- Exposure period: on D7 (epidermal, 48-hr exposure); approximately 24 hours following patch application, all wrappings were removed and any residual test article was wiped and washed with a gauze pad moistened with propylene glycol. Approximately 21 hours following patch removal, the test sites were reclipped as previously described and three hours thereafter the test sites were scored for irritation. The scoring was repeated 24 hours later.
- Test groups:
Study 1: The test item at 100%, 50%, 25%, and 10%, in propylene Glycol
Study 2: The test item at 10%, 5%, and 1.0%, in propylene Glycol
- Site: on the backs of the animals, two pads on each side of the spine with one near the shoulder and one near the hip. The animals were then occlusively wrapped with a sheet of nonreactive, rubberized material which was securely taped in place with nonirritating tape. This covering was secured with adhesive Blenderm tape.
- Frequency of applications: once
- Duration: 48 hours
- a volume of 0.4 mL of each concentration of the test article was applied individually to 2x2 cm Webril pads.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injections + topical application)
- Type of epicutaneous induction: occlusive
- Exposure period: on D0 (intradermal) and D7 (epidermal, 48-hr exposure)
- Test groups:
* INTRADERMAL INDUCTION
- Site: on the day of dosing , the hair was clipped from the scapular region of the test, positive and negative control animals. Three pairs of intradermal injections were made in the clipped area of each animal. The injections were kept within a boundary of a 2x4cm area with one row of 3 injections on each side of the spine:
1) 0.1mL of FCA emulsion
2) 0.1 mL of 5% (w/w) test article in propylene glycol
3) 0.1 mL of 5% (w/w) test article
- positive control animals:
1) 0.1mL of FCA emulsion
2) 0.1mL of 0.1% DNCB in PG
3) 0.1mL of 0.1% DNCB in FCA emulsion
- negative control animals
1) 0.1mL of FCA emulsion
2) 0.1mL of PG
3) 0.1mL of 5% PG in FCA emulsion
Injections 1 and 2 were administered close to one another and nearest to the head, injection 3 was administered most caudally.
*TOPICAL ADMINISTRATION (day 7)
- on the day of dosing, the hair was reclipped from the scapular region of the test, positive and negative control animals.
- Control group: positive control 0.8mL 0.1% DNCB and negative control 0.8mL propylene glycol
- Test group: 0.8mL test item (neat) at 100% (w/v)
- Site: Each dose was first applied to a 2 x 4 cm Webril pad which was immediately applied over the intradermal injection sites. Immediately following patch application, the sites were wrapped.
- Frequency of applications: once
- Duration: 48 hours, approx 48hrs after application, all wrappings were removed
B. CHALLENGE EXPOSURE
- on day 28, the hair was clipped from the left and right flanks of the test, positive and negative control animals
- No. of exposures: 1 (topical application)
- Day of challenge: day 28
- Exposure period: 24 hours
- Test groups and negative challenge control: 0.4mL of 5% w/v test article in Propelyne Glycol on the posterior left flank and 0.4 mL Propylene Glycol only on the posterior right flank.
-Positive control group (incl. positive challenge group): 0.4 mL of 0.1% DNCB in Propylene Glycol on the posterior left flank and0.4mL of propylene Glycol on the posterior right flank
- each dose was first applied to a 2x2 cm webril pad which was immediately applied to the previously designated sites. Immediately following patch application, the animals were wrapped.
- Evaluation: approx 24 hours following patch application, all wrappings were removed and, if necessary, any residual material was wiped and washed from the site using a gauze pad moistened with PG. Approx. 21 hours following patch removal, all test sites were reclipped and three hours thereafter, the sites were scored for irritation. The scoring was repeated 24 hours later (approx 48 hours post patch removal).
C. RECHALLENGE PHASE
- No. of exposures: 1 (topical application)
- Day of challenge: day 28, the hair was clipped from the left and the right flanks of the test and negative rechallenge control group animals.
-Test groups and negative rechallenge control: 0.4 mL of 5% w/v test article in Propelyne Glycol on the anterior left flank and 0.4mL of Propylene Glycol on the anterior right flank.
- each dose was first applied to a 2x2cm Webril pad which was immediately applied to the designated sites.
- Evaluation: 48 hours post patch removal - Challenge controls:
- - Negative challenge control: 5% w/v test article in Propylene Glycol on the posterior left flank and Propylene Glycol only on the posterior right flank.
- Positive challenge group: 0.1% DNCB in Propylene Glycol on the posterior left flank and propylene Glycol on the posterior right flank - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB) (CAS No: 97-00-7)
Results and discussion
- Positive control results:
- At challenge, all of the DNCB positive control animals had positive scores of one or greater at both 24 and 48 hour scoring periods. None of the DNCB challenge control animals had positive responses.
Under the conditions of this test, the positive control DNCB was considered to be an Extreme Sensitizer (100% sensitized) and test article MIBKO (199-898) was considered to be a Nonsensitizer (0% sensitized).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 15
- Remarks on result:
- other: score was +/-
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Remarks on result:
- other: score was +/-
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Remarks on result:
- other: score was +/-
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0%; propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB in PG
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Clinical observations:
- eschar at test site of 1 animal
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- confirmed as extreme sensitiser
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNCB in PG
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Clinical observations:
- eschar at test site in 4/15 animals
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- confirmed as extreme sensitiser
Any other information on results incl. tables
Body weight:
All animals gained weight by the end of the study period.
Mortality:
- One animal in the test article group died during the study period.
- A gross necropsy was performed on this animal : heart was discolored yellow and the stomach and the gastrointestinal tract were distended with gas. All other organs and tissues appeared normal.
Detailed results on animals are shown in the following tables:
CHALLENGE SCORES
Table 1: MIBKO challenge control
Animal ID # | 24 H Erythema test | 24 H Erythema vehicle | 48H Erythema test | 48H Erythema vehicle |
Q821 | 0 | 0 | 0 | 0 |
Q824 | 0 | 0 | 0 | 0 |
Q858 | 0 | 0 | 0 | 0 |
Q862 | 0 | 0 | 0 | 0 |
Q892 | 0 | 0 | 0 | 0 |
None of the challenge control animals had positive responses.
Table 2: MIBKO test animals
Animal ID # | 24 H Erythema test | 24 H Erythema vehicle | 48H Erythema test | 48H Erythema vehicle |
Q823 | 0 | 0 | 0 | 0 |
Q826 | 0 | 0 | 0 | 0 |
Q829 | * | * | * | * |
Q831 | 0 | 0 | 0 | 0 |
Q835 | 0 | 0 | 0 | 0 |
Q837 | 0 | 0 | 0 | 0 |
Q839 | 0 | 0 | 0 | 0 |
Q842 | 0 | 0 | 0 | 0 |
Q865 | 0 | 0 | 0 | 0 |
Q871 | 0 | 0 | 0 | 0 |
Q872 | 0 | 0 | 0 | 0 |
Q885 | 0 | 0 | 0 | 0 |
Q893 | 0 | 0 | 0 | 0 |
Q897 | 0 | 0 | 0 | 0 |
Q904 | +/- | 0 | 0 | 0 |
*Not Applicable, animal died on test.
One animal had a score of +/- at the 24 hour scoring period. this score had reduced to 0 at the 48 hour scoring period.
Table 3: DNCB Positive Control
Animal ID # | 24 H Erythema test | 24 H Erythema vehicle | 48H Erythema test | 48H Erythema vehicle |
Q832 | 2 | 0 | 1 | 0 |
Q843 | 2 | 0 | 2 | 0 |
Q854 | 3 | 0 | 3 | 0 |
Q855 | 3 | 0 | 3** | 0 |
Q860 | 3 | 0 | 2 | 0 |
Q864 | 2 | 0 | 3** | 0 |
Q877 | 2 | 0 | 1 | 0 |
Q880 | 3** | 0 | 3** | 0 |
Q895 | 3 | 0 | 3 | 0 |
Q899 | 2 | 0 | 3** | 0 |
** Eschar at test site
Table 4: DNCB Challenge Control
Animal ID # | 24 H Erythema test | 24 H Erythema vehicle | 48H Erythema test | 48H Erythema vehicle |
Q850 | 0 | 0 | 0 | 0 |
Q853 | 0 | 0 | 0 | 0 |
Q857 | 0 | 0 | 0 | 0 |
Q869 | 0 | 0 | 0 | 0 |
Q902 | 0 | 0 | 0 | 0 |
RECHALLENGE SCORES
Table 5: MIBKO Rechallenge control
Animal ID # | 24 H Erythema | 48 H Erythema |
Q833 | 0 | 0 |
Q838 | 0 | 0 |
Q881 | 0 | 0 |
Q886 | 0 | 0 |
Q900 | 0 | 0 |
Animal ID # 24 H Erythema 48 H Erythema
Table 6 : MIBKO Test Animals
Animal ID # | 24 H Erythema | 48 H Erythema |
Q823 | 0 | 0 |
Q826 | 0 | 0 |
Q829 | * | * |
Q831 | 0 | 0 |
Q835 | 0 | 0 |
Q837 | 0 | 0 |
Q839 | 0 | 0 |
Q842 | 0 | 0 |
Q865 | 0 | 0 |
Q871 | +/- | +/- |
Q872 | 0 | 0 |
Q885 | 0 | 0 |
Q893 | 0 | 0 |
Q897 | 0 | 0 |
Q904 | +/- | +/- |
At rechallenge, two of the test animals had scores of +/- at both the 24 and 48 hour scoring periods. These responses of +/- are considered to be equivocal and therefore not considered to be positive sensitising responses.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the positive control DNCB was considered to be an Extreme Sensitizer (100% sensitized) and test article MIBKO (199-89B) was considered to be a Nonsensitizer (0% sensitized).
- Executive summary:
MIBKO (Sample No 199 -89B) was evaluated for allergic contact sensitization using the maximization test on female guinea pigs. This involved two induction exposures. MIBKO was first administered by intradermal injection and second by topical exposure, followed by a topical challenge exposure 21 days after the first induction. At challenge, none of the animals developed any skin reactions indicating sensitisation. A topical rechallenge phase was performed on day 28 to confirm the negative results of the challenge phase. MIBKO produced no signs of contact sensitization and was classified as a nonsensitizer (0% sensitized).
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