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EC number: 484-460-1 | CAS number: 37859-55-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The registrant obtained letter of access to the study. The study was originally designed to comply the standards set forth in EPA Heatlh Effects Test Guidelines, OPPTS 870.2600 which is in accordance to the OECD guideline 406.
Test material
- Reference substance name:
- -
- EC Number:
- 484-470-6
- EC Name:
- -
- Cas Number:
- 623-40-5
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 2-Pentanone, oxime
- Test material form:
- liquid
- Remarks:
- Clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Methyl propyl ketoxime (MPKO)
- Molecular formula (if other than submission substance): C5H11NO
- Molecular weight (if other than submission substance): 101.15
- Smiles notation (if other than submission substance): C\C(CCC)=N\O
- InChl (if other than submission substance): Mixture of all possible stereoisomers
Constituent 1
- Specific details on test material used for the study:
- See ilustration.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, MA
- Weight at study initiation: 296-350 g males, 292-352 g females
- Housing: Individually in suspended wire cages with paper bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation for at least 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs
IN-LIFE DATES: From: 01/04/2009 To: 08/05/09
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 hours once a week for 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 6 hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test groups: 10 M/10 F
Control group: 5 M/5 F - Details on study design:
- RANGE FINDING TESTS: non irritating dose = 25%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females were untreated for the three week induction period and served as the naive control.
- Site: Left shoulder area (site 1)
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 100% (0.4 ml)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks following last induction
- Exposure period: 6 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: Lower left dorsal area (site 3)
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours following patch removal.
OTHER: SCREEN (Site 2): Each animal received 4 concentrations of the test article, one/site. Each concentration (10, 25, 50 and 100%) under occlusive conditions. After 6 hours, the dams and test article were removed, the sites cleansed with distilled water and dried with soft towelling. Treated sites were examined and scored 24 and 48 hours following patch removal.
All the reactions were evaluated for Erythema:
Scoring code:
No erythema: 0
Very faint, usually non-confluent: 0.5
Faint, usually confluent: 1
Moderate 2
Strong, with or without edema: 3
All animals were observed once/day for mortality and toxicity.
Body weights were recorded pretest and at termination. - Positive control substance(s):
- yes
- Remarks:
- HCA
Results and discussion
- Positive control results:
- Testing with 85% hexylcinnamaldehyde are confirmed in the laboratory every 6 months. Data from the study conducted in summer 2009 included with results as expected.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction 0%, challenge 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction 0%, challenge 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction 100%, challenge 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction 100%, challenge 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
Any other information on results incl. tables
Dermal observations: Induction: Erythema was absent to faint. Challenge: Erythema was absent to faint in the induced group and absent in the naive control group.
Body weights: Body weight changes were normal.
Systemic observations: In the treated group, one male and one female were observed with soiling of the anogenital area and one male was observed with soiling/wetness of the anogenital area. In the control group one male was observed with soiling of the anogenital area. All others appeared normal.
The data matrix is included in the reporting format attached.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- CLP criteria.
- Conclusions:
- MPKO was not a skin sensitizer under the conditions of this study.
- Executive summary:
A skin sensitization study was performed with the test substance MPKO according to OECD Guideline 406. 15 male and 15 female Guinea pigs were used. In the first group, 10 animals per sex were induced with MPKO at 100% receiving 3 topical induction applications once a week for 3 weeks. Skin reactions were recorded after 24 and 48 patch removal. In the second group, the animals were not induced and served as a naive control. Based on preliminary screening results, 25% was chosen as the highest non-irritating concentration for the challenge and was administered to both groups two weeks after the third induction. The skin reactions were recorded at 24 and 48 hours following patch removal. After the induction, erythema was absent to faint. After the challenge, erythema was absent to faint in the induced group and absent in the naive control group. MPKO was determined to be non-sensitizer to the skin.
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.
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