Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-496-6 | CAS number: 96-29-7
- 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
Endpoint summary
Administrative data
Description of key information
Skin sensitization (equivalent to 406), GPMT and Buehler: sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed prior to the implementation of the LLNA method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Age at study initiation: 5-6 weeks of age
- Weight at study initiation: 204 - 315 g
- Housing: individually housed in wiremesh cages
- Diet (e.g. ad libitum): NIH Amimal Feed A, certified feed, Zeigler Brothers, Gardners, PA - ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Housed in an environmentally controlled room
- Photoperiod (hrs dark / hrs light): 12/12
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Day 0 Induction: Intradermal injection of 3% MEKO in propylene glycol and intradermal injection of 1% MEKO in Freunds Complete Adjuvent.
Day 7 Induction: Topical occluded patch with 0.3 mL of undiluted MEKO - Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Day 21 Challenge: Topical occluded patch with 0.2 mL of 50% MEKO in propylene glycol to left side and topical occluded patch with 0.2 mL of undiluted MEKO on the right side.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
For topical applications under occlusion, concentrations of 25, 50, 75 MEKO in propylene glycol and 100% MEKO were applied for 24 hours and the skin evaluated for irritation potential.
For intradermal injections, concentrations of 0.1, 1, 3, and 5% MEKO in propylene glycol and in Freunds Complete Adjuvent (FCA) were evaluated for irritation potential. 3% MEKO in propylene glycol and 1% MEKO in FCA was chosen for induction on day 0.
- Challenge controls:
- Vehicle control group
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2, 4-dinitrobenzend (DNCB)
- Positive control results:
- The positive control showed the expected effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% MEKO
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% MEKO
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% MEKO
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% MEKO
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Methyl ethyl ketoxime is a strong skin sensitizer in guinea pigs.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed prior to the implementation of the LLNA method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Indianapolis, IN
- Weight at study initiation: 300-400 g
- Housing: One per cage in suspended wire mesh bottom cage.
- Diet (e.g. ad libitum): Agway Prolab Guinea Pig Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-79
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 25%
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 5%
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
A volume of 0.3 mL of concentrations of 100% (neat), 50, 25 and 10% MEKO in propylene glycol were evaluated for irritation potential.
A volume of 0.3 mL of concentrations of 1 and 5% MEKO in propylene glycol were evaluated for irritation potential.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours for each of 9 induction applications
- Test groups: 10
- Control group: 5
- Site: one flank used for all 9 induction applications
- Frequency of applications: every other day
- Duration: 24 hours/application
- Concentrations: 25% MEKO w/v in propylene glycol; a volume of 0.3 mL was applied
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after last induction application
- Exposure period: 24 hours
- Test groups: 10
- Control group: 5
- Site: flank not exposed to induction applications
- Concentrations: 5% MEKO w/v in propylene glycol: a volume of 0.3 mL was applied
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: A second challenge was performed 1 week after the first challenge at 5% MEKO w/v in propylene glycol - Challenge controls:
- Five guinea pigs were dosed with 0.3 mL of propylene glycol 9 times for induction. The same 5 guinea pigs were dosed at challenge with 0.3 mL of 5% MEKO in propylene glycol.
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
- Positive control results:
- Positive allergic contact sensitization occurred in 10 of 10 positive control guinea pigs, thus validating the test procedure.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% induction, 5% challenge
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% induction, 5% challenge
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% induction, 5% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% induction, 5% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% dintrochlorobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema, eschar, edema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% dinitrochlorobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema, eschar, edema
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% induction, 5% challenge
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% induction, 5% challenge
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Interpretation of results:
- other: Category 1B based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- Methyl ethyl ketoxime induced allergic contact dermatitis in guinea pigs in this modified Buehler closed-patch skin sensitisation study.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The test substance was a skin sensitiser when evaluated in guinea pigs. In the guinea pig maximisation test, conducted by Food & Drug Research Laboratories, Inc. (1983), animals were induced intradermally with 3% the test substance in propylene glycol, followed by epidermal induction on day 7 with 0.3 mL of undiluted the test substance under occlusion. On day 21, animals were challenged epidermally with 0.2 mL of 50% the test substance in propylene glycol on the left side and 0.2 mL of undiluted the test substance on the right side under occlusion. At least 80% of animals exhibited a positive response. Positive and negative controls were valid, confirming the reliability of the used test method.
A test using a similar protocol (4% intracutaneous induction, 100% occlusive epicutaneous induction, and a 50% occlusive epicutaneous challenge) resulted in a 70 percent sensitisation rate (RCC NOTOX, 1989).
When evaluated by the Buehler method (Springborn Life Sciences, Inc., 1989) guinea pigs were induced epidermally with 25% the test substance in propylene glycol, using 9 occluded 24-hour exposures every other day. This was followed by epicutaneous challenge with 5% the test substance in propylene glycol under occlusion. Results were scored 24 and 48 hours after the test patch removal. Positive reactions were observed in 6 of 10 animals. Upon rechallenge with 5% the test substance, positive responses were observed in 9 of 10 animals. Based on these results, the test substance is concluded to be sensitising in guinea pigs.
Also a local lymph node assay (LLNA) in mice, performed under GLP and according to OECD Guideline 429 (2009) is available. The stimulation indices were 1.3 and 1.0 for 50% (acetone : olive oil in 4:1 (v/v) ratio was used as a vehicle) and 100% the test substance, respectively. The study gave thus a negative result. The positive control behaved accordingly. According to CLP, a significant sensitising effect is defined by a stimulation index of >=3. Therefore, under the conditions of this study, butanone oxime is not sensitising.
The results of two GPMTs and one Buehler test all give solid support for the classification of butanone oxime as a skin sensitiser. The results of a recently and well-performed LLNA with butanone oxime did not show any evidence of skin sensitisation. Despite the negative result from the LLNA, the weight of evidence provided indicates that butanone oxime should be classified as a skin sensitiser. All three tests providing a positive result indicate classification in sub-category 1B.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.