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EC number: 203-837-1 | CAS number: 111-13-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication .
Data source
Reference
- Reference Type:
- publication
- Title:
- THE SENSITIZATION POTENTIAL OF SOME PERFUME INGREDIENTS TESTED USING A MODIFIED DRAIZE PROCEDURE
- Author:
- D.W. SHARP
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 9 (1978) 261-271
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modified Draize test method.
- Principles of method if other than guideline:
- Modified Draize Technique was employed to determine the concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration ( ACC) ] of the test chemical
- GLP compliance:
- not specified
- Type of study:
- Draize test
- Justification for non-LLNA method:
- not specified.
Test material
- Reference substance name:
- Octan-2-one
- EC Number:
- 203-837-1
- EC Name:
- Octan-2-one
- Cas Number:
- 111-13-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- octan-2-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material: Octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.21 g/mol
- Substance type: Organic
- Physical state: Liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 350 g
- Housing: Housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): Pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): water ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: yes (no details mentioned)
- Concentration / amount:
- Induction concentration: 0.1 mL at 2.5 X 1%(ICC) : 10 guinea pigs
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).
Challenge
- No.:
- #1
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: yes (no details mentioned)
- Concentration / amount:
- Challenge concentration: 0.1 mL at 1% (ICC) and 20% (ACC): 10 guinea pigs
Re- challenge concentration: 0.1 mL at 1%(ICC) and 20% (ACC): 10 guinea pigs - Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC)
- No. of animals per dose:
- 10 animals (4male and 6 female)
- Details on study design:
RANGE FINDING TESTS: For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing.
MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures:4
- Exposure period: No Data Available
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: 4 sites, 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications:1
- Duration: No Data Available
- Concentrations: 0.1 mL at 2.5 X 1% (ICC)
B. CHALLENGE EXPOSURE: Intradermal and Epicutaneous
- No. of exposures:1
- Day(s) of challenge: Fourteen days later, challenge test was performed
- Exposure period:24 hours
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: onto the shaved flank in a small circular area
- Concentrations: 0.1 mL at 1% (ICC) and 20%(ACC).
- Evaluation (hr after challenge):24 hours
C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 7 Days Later , rechalleange test was performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 1% (ICC) and 20% (ACC).
- Evaluation (hr after challenge): No Data Available
-Other:
Observations and scoring –
Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale. Reactions were examined under a Philips colour-matching unit with 3 Philips 40 W Actinic Blue 05 fluorescent tubes and 3 Philips 40 W White 35 fluorescent tubes.- Challenge controls:
- At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml at 1%[ICC] and 20%[ACC]
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization reactions was observed at the tested concentrations
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
SENSITIZATION POTENTIAL OF SYNTHETIC PERFUME INGREDIENTS
Non-sensitizer = no evidence of sensitization
Test chemical |
ICC(%) |
ACC(%) |
Results |
111 -13 -7 |
1 |
20 |
Not sensitizer |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- No signs of contact sensitization were observed at 1% ICC and 20% ACC concentrations. Hence, the test chemical was considered to be non-sensitizing to the skin of albino Hartley guinea pigs..
- Executive summary:
Modified Draize Technique was employed to determine the concentrations suitable\ for sensitization testing [injection challenge concentration(ICC) and application challenge concentration ( ACC) ] of the test chemical
Hartley strain albino guinea pigs bred were used for the study. Four guinea pigs of same sex were used for the preliminary irritation study and 10 guinea pigs were used for the main sensitization studyand 4 previously untreated animals of the same sexwere used as challenge controls.
The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]
The ICC and ACC for the test chemical was determined to be 1% and 20% respectively
In the induction phase, 0.1 ml aliquots of test substance at 2.5 times the ICC were injected intradermally at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes. After a rest period of 14 days, each animal was challenged
intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC: the topical application was made by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered. Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included.At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.
Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls.
No signs of contact sensitization were observed at 1% ICC and 20% ACC concentrations. Hence, the test chemical ewas considered to be non-sensitizingto the skin of albino Hartley guinea pigs.
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