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EC number: 202-708-7 | CAS number: 98-86-2
- 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 sensitisation: not considered as sensitising (based on a weight of evidence approach with test results from a modified Draize test and a Human Repeated Insult Patch Test).
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: peer reviewed database
- Principles of method if other than guideline:
- peer reviewed database, method not reported
- GLP compliance:
- not specified
- Type of study:
- other: not specified
- Justification for non-LLNA method:
- The data was available before the validation of the LLNA method.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study meets generally accepted scientific principles as a modification of a standard Draize test procedure, selection of test concentrations based on preliminary irritation tests both for intradermal injection and topical application, suffcient description of test protocol; minor restrictions: only qualitative test result presented in a table, no data on sensitisation scores for the test group or individual test animals; limited number of 10 test animals, no replicate study; study acceptable as supporting information
- Principles of method if other than guideline:
- Draize test with modified protocol for induction
- GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- The study was carried out in 1978, before the validation of the LLNA method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: inbred from own colony
- Weight at study initiation: 350 g
- Housing: in pairs
- Diet: ad libitum
- Water: ad libitum - Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- 2.5 x ICC (ICC: 0.25%)
- Day(s)/duration:
- 4 injections on Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- intradermal: ICC = 0.25%
epicutaneous: ACC = 20% - Day(s)/duration:
- Day 14 (24h duration for epicutaneous application)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- - Induction treatment:
0.1 ml aliquots of the test substance at 2.5 times the injection challenge concentration were administered on one occasion as 4 intradermal injections at 4 sites which overlie the 2 auxilary and 2 inguinal lymph nodes. Induction time was 14 days.
- Challenge treatment:
intradermal injection in one flank and topical application on the other flank by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered.
- Scoring of reactions:
24 hrs later
Apparent sensitization reactions were confirmed 7 days later by a second challenge.
In the absence of sensitisation reactions at first challenge, the induction and challenge procedures were repeated, but htis time a confirmatory challenge with controls was included.
- Controls:
At each challenge 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.
- Scoring:
Injection reaction: total score based on size, erythema and oedema.
Positive reaction: total score of individual reaction significantly greater than the total average score for control reactions.
Application reaction: 0 to +++ scale
Positive reaction: (a) scoring >= + and (b) no erythema reactions in controls - Positive control substance(s):
- yes
- Remarks:
- other test substances that yielded positive test results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.25% intradermal (ICC) and 20% epicutaneous (ACC)
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No. with + reaction not available but conclusion is "Non-sensitizer"
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.25% intradermal (ICC) and 20% epicutaneous (ACC)
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- No. with + reaction not available
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- in the same publication positive results were obtained with several other substances used as positive controls.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acetophenone was assessed as non-sensitiser in a modified Draize test with Hartley guinea pigs.
- Executive summary:
Acetophenone was tested in a modified Draize test with groups of 10 male and female Hartley guinea pigs. For induction treatment, 0.1 ml aliquots of the test substance at 2.5 times the injection challenge concentration (ICC) were administered on one occasion as 4 intradermal injections at 4 sites which overlied the 2 auxilary and 2 inguinal lymph nodes. After an induction time of 14 days, the challenge treatment consisted of an intradermal injection in one flank and topical application (uncovered) on the other flank with an application challenge concentration (ACC) of 20 %. Reactions were scored 24 hrs later. In the absence of sensitization reactions at first challenge, the induction and challenge procedures were repeated, but this time a confirmatory challenge with controls was included. At each challenge 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. Acetophenone was assessed as non-sensitiser (no details on test results available).
Referenceopen allclose all
/LABORATORY ANIMALS: ... No skin- sensitizing potential was demonstrated. when solutions of acetophenone were tested on guinea-pigs. [BIBRA working group; TA:Toxicity profile. BIBRA Toxicology International: 4 (1991) ]**PEER REVIEWED**
Negative (no details of test results reported)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
An evaluation of the sensitizing potential of acetophenone is possible based on a weight of evidence approach with test results from a modified Draize test and a Human Repeated Insult Patch Test.
Acetophenone was assessed as non-sensitizer in a modified Draize test (no guideline study) with 10 Hartley guinea pigs at challenge concentrations of 0.25% for injection and 20% for topical application. The selection of test concentrations was based on preliminary irritation tests both for intradermal injection and topical application (Sharp et al., 1978). No information is available on sensitisation scores or other details of test results.
In a Human Repeated Insult Patch Test, 2% acetophenone in petrolatum did not provoke a sensitizing response in human volunteers (number not specified). The test protocol consisted of pretreatment of the skin test site with a mild irritant, five 48-hour closed patches during a 10-day induction period followed by 10-14 days without treatment, and a final 48-hour closed patch for challenge (Kligman, 1971, cited from BIBRA, 1987).
Migrated from Short description of key information:
A modified Draize test with Hartley guinea pigs (no guideline study) revealed that acetophenone is a no sensitizer. In a peer reviewed database acetophenone is reported to be not sensitizing.
Human Repeated Insult Patch Test: test result negative
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on a weight of evidence approach with test results from a modified Draize test and a Human Repeated Insult Patch Test, showing negative responses, no classification of acetophenone for skin sensitisation is required.
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