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EC number: 208-793-7 | CAS number: 541-85-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study comparable to guideline; non GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- The sensitization potential of some perfume ingredients tested using a modified Draize procedure.
- Author:
- Sharp, D.W.
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 9, 261-271.
Materials and methods
- Principles of method if other than guideline:
- Skin sensitisation of Ethyl amyl ketone on 10 guinae pigs was tested using a modified Draize technique. A preliminary irritation test was conducted to determine the suitable concentrations for the sensitising test. Following the preliminary test, new experiments were performed with animals being treated by intradermal injection to induce senitisation. They were challenged 2 weeks after, both by intradermal injection and topical application. When no sensititzation was observed, the induction and challenge steps were repeated.
- GLP compliance:
- no
- Remarks:
- Study performed before the introduction of GLP
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Available study performed in 1978 well documented comparable to guideline but non GLP
Test material
- Reference substance name:
- Ethyl amyl ketone
- IUPAC Name:
- Ethyl amyl ketone
- Details on test material:
- -Name of test material (as cited in the study report): Ethyl amyl ketone
-Assigned identity of test material: 3-Octanone (CASNr: 106-68-3)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Inbred Hartley strain albino guinea pigs weighing about 450g and bred in own colony were used. They were housed in pairs of the same sex in wire mesh cages. They were fed pelleted guinea pig diet, cabbage, hay and water ad libitum.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- Preliminary irritation test for injection challenge concentration (concentration inducing slight but perceptible irritation but no oedema, ICC) and application challenge concentration (highest concentration causing no irritation, ACC):
Intradermal: 0.1 ml aliquots of a range of concentrations
Topical: 0.1 ml aliquots of a range of concentrations
Sensitization test: total dose was administered on one occasion as 4 intradermal injections, each 2.5x the injection challenge concentration (ICC).
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Concentration / amount:
- Preliminary irritation test for injection challenge concentration (concentration inducing slight but perceptible irritation but no oedema, ICC) and application challenge concentration (highest concentration causing no irritation, ACC):
Intradermal: 0.1 ml aliquots of a range of concentrations
Topical: 0.1 ml aliquots of a range of concentrations
Sensitization test: total dose was administered on one occasion as 4 intradermal injections, each 2.5x the injection challenge concentration (ICC).
- No. of animals per dose:
- Preliminary irritation test: 4 animals of same sex
Sensitization test: 10 animals in each test, 4 males and 6 females or vice versa. - Details on study design:
- Modified from Draize. 10 guinea pigs at about 350 g (at the start of the experiment) were used. 0.1 ml aliquots of the test item at 2.5 times the injection challenge concentration (ICC) were injected at 4 sites. Each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliqouts of test substance at ethe respective injection challenge concentration (ICC) and applicable challenge concentration (ACC) 14 days later. The reactions were scored 24 h after and apparent sensitization reactions were confirmed 7 days later by a second challenge with controls.
- Challenge controls:
- 4 previoulsy untreated animals of the same sex and similar weight were treated intradermally and topically with 0.1 ml aliquots of the test substance at the injection challenge concentration (ICC) and applicable challenge concentration (ACC), respectively.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- rechallenge
- Hours after challenge:
- 192
- Group:
- test chemical
- Dose level:
- 0.2% (injection) and 20% (application)
- Clinical observations:
- none compared to controls
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 192.0. Group: test group. Dose level: 0.2% (injection) and 20% (application). Clinical observations: none compared to controls.
Any other information on results incl. tables
Injection challenge concentration ICC (%): 0.2
Applicable challenge concentration ACC (%): 20
Result: non-sensitizer (= no evidence of sensitization using the test procedure described)
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: as described above
- Conclusions:
- Ethyl amyl ketone (3-Octanone, CASNr: 106-68-3) is not sensitising.
- Executive summary:
A modified Draize procedure was used to test the potential to induce allergic contact dermatitis in guinea pigs. Ethyl amyl ketone (3-Octanone, CASNr: 106-68-3) was found not sensitising.
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