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EC number: 202-257-6 | CAS number: 93-55-0
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: study well documented, meets generally accepted scientific principles. However, there are no details about tested susbtance (i.e. purity, composition, etc).
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:
- Modified Draize test performed to assess the test item potential to induce allergic contact dermatitis in guinea pigs.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Type of study:
- Draize test
- Justification for non-LLNA method:
- A LLNA study has not been conducted because a adequate data from a previously conducted experiment already exists.
Test material
- Reference substance name:
- 1-phenylethanone
- IUPAC Name:
- 1-phenylethanone
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
- Source: inbred albino guinea pigs bred in the testing laboratory colony.
- Weight at study initiation: about 350 g.
- Housing: animals were housed in wire mesh cages in pairs of the same sex.
- Diet: pelleted guinea pig diet, cabbage, ad libitum.
- Water: ad libitum.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- Intradermal injection challenge concentration (ICC): 0.25 %
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- Topical application challenge concentration (ACC): 20 %
- Day(s)/duration:
- 21
- No. of animals per dose:
- 10
- Details on study design:
- SENSITIVITY
For demonstration of sensitivity by challenge with the test substance, the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.
PRELIMINARY IRRITATION TEST
For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing. Guinea pigs were then treated by intradermal injection to induce sensitization and challenged 2 weeks later by both intradermal injection and topical application. When there was no evidence of sensitization the induction and challenge procedures were repeated.Intradermal injection. Four animals of the same sex and weighing about 450 g were each injected intradermally on the shaved flanks with 0.1 ml aliquots of a range of concentrations of tests material in a suitable solvent. The reactions were examined for size (two largest diameters), erythema and oedema 24 h later and the concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).Topical application. Aliquots (0.1 ml) of a range of concentrations of test substance in a suitable solvent were applied in small circular areas to the shaved flanks of 4 guinea pigs of the same sex and weighing about 450 g. The reactions were examined for erythema 24 h later and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC).
MAIN TEST
Induction treatmentFor each animal 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.Challenge treatmentFourteen days after induction 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.Apparent sensitization reactions would be confirmed 7 days later by a second challenge with controls included.In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, but this time a comfirmatory challenge with controls was included irrespective of any apparent sensitization reactions at the previous challenge.SCORINGReactions 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. 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 and individual reactions were considered positive if (a) they were + or greater and (b) there were no erythema reactions in controls. - 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.
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
non-sensitizer
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The substance was evaluated to be non sensitising on guinea pigs.
- Executive summary:
Modified Draize test was performed to assess the test item potential to induce allergic contact dermatitis in guinea pigs. For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing. Guinea pigs were then treated by intradermal injection to induce sensitization and challenged 2 weeks later by both intradermal injection and topical application. When there was no evidence of sensitization the induction and challenge procedures were repeated. The Injection challenge concentration was 0.25 %, while the application challenge concentration (ACC) was 20 %. The test item does not shown signs of sensitisation potential.
Conclusion
non-sensitizer
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