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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 irritation: not irritating (testing procedure being comparable to OECD Guideline 404, skin contact 24 hrs with occlusion): primary irritation score for intact skin 0.5 (Key study: Worstmann, 1980)
Eye irritation potential (testing procedure comparable to OECD Guideline 405): no effects (Key study: Worstmann, 1980; supporting study: Marzin, 1978; Worstmann, 1980)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (more severe exposure conditions: prolonged skin contact of 24 hrs, occlusive dressing, treatment of intact and scarified skin, scoring of skin lesions at 24 and 72 hrs)
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the USA, Code of Federal Regulations, Title 16, Section 1500.41
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: J. Scheele, Büderich/Westfalen, 4760 Werl, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1 °C
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- shaved, or shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 24 and 72 hrs after start of exposure
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Application: the test substance was dispensed on 2.5 x 2.5 cm2 patches which were then applied to the prepared skin areas and fixed by elastoplast; patches were removed after 24 hrs of skin contact
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: unpermeable material as e.g. a rubber cloth
SCORING SYSTEM: according to Draize, comparable to OECD Guideline 404 (for details see Table 1)
Calculation of primary dermal irritation index:
sum of the scores of each animal for [(Erythema and eschar formation) + (Oedema formation) from intact skin] + [(Erythema and eschar formation) + (Oedema formation) from scarified skin] divided by 24; maximal achievable value is 8.0
For criteria for classification see Table 2 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 0.63
- Reversibility:
- fully reversible within: 48 hrs after termination of application
- Remarks on result:
- other: includes reactions both for intact and abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hrs
- Score:
- 0.5
- Reversibility:
- fully reversible within: 48 hrs after termination of application
- Remarks on result:
- other: reaction for intact sklin
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritant / corrosive response data:
- see Table 3
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With a primary irritation index of 0.5 after a 24-hr contact with intact skin, the classification would be "not irritating" according to the ETAD criteria.
No classification according to EU criteria is expected as mean irritation scores for erythema or edema were significantly below the critical value of 2.0 even under the conditions of this test with a prolonged contact time of 24 hrs instead of 4 hrs. - Executive summary:
Skin irritation scores according to Draize were assessed on skin sites of six rabbits (both shaved intact skin or shaved scarified skin) following a 24-hr occlusive application of 0.5 mL acetophenone on a patch. Except for the prolonged skin contact the testing procedure was comparable to OECD Guideline 404. Findings at the end of exposure on intact skin were very slight erythema in 2/6 rabbits and very slight oedema in 4/6 rabbits. Abraded skin sites showed very slight erythema in 2/6 and slight erythema in 1/6, and very slight oedema in 5/6 rabbits. All effects were fully reversible within the following 48 hrs. With a primary irritation index (PII) of 0.63 after a 24-hr skin contact, acetophenone was assessed as slightly irritating to rabbit skin according to ETAD criteria (PII of 0.6 -3.0) when the reactions of both intact and scarified skin were considered. With a PII of 0.5 for intact skin acetophenon is non irritating.
No classification according to EU criteria is expected as mean irritation scores for erythema or edema with maximal scores of 1.0 for intact skin were significantly below the critical value of 2.0 even under the conditions of this test with a prolonged contact time of 24 hrs instead of 4 hrs.
Reference
Table 3: Overview on skin reactions after single occlusive application of acetophenone for 24 hrs (scores at the end of the exposure period)
Rabbit No. | Erythema score | Edema score | ||
intact skin | scarified skin | intact skin | scarified skin | |
1 | 1 | 1 | 1 | 1 |
2 | 1 | 1 | 1 | 1 |
3 | 0 | 0 | 1 | 1 |
4 | 0 | 0 | 1 | 1 |
5 | 0 | 2 | 0 | 1 |
6 | 0 | 0 | 0 | 0 |
All changes were fully reversible within the following 48 hrs: all scores were 0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no scoring at 1 hr after instillation of test substance)
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission of the USA, Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: J. Scheele, Büderich/Westfalen, 4760 Werl, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1 °C
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- no washout of test substance
- Observation period (in vivo):
- 24, 48, 72 hrs, 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize (see Table 1)
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no effects at any timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acetophenone had no irrtitating effect on rabbit eyes.
- Executive summary:
The eye irritation potential of 0.1 mL acetophenone was investigated in 6 rabbits following a testing procedure comparable to OECD Guideline 405 (without scoring at 1 hr post instillation). According to the scoring system of Draize there was no adverse reaction at any timepoint from 24 hrs to 7 days post application. Acetophenone had no irrtitating effect on rabbit eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Two skin irritation studies are available that applied test protocols similar to OECD Guideline 404 except for the more severe condition of a 24 hr skin contact under an occlusive dressing and an observation period limited to 72 hrs after the start of exposure (Marzin, 1978; Worstmann, 1980). Based on the slight signs of irritation reported at the end of exposure and the tendency of the skin effects to be reversible within the next 48 hrs, these studies can be used as key studies to make a conclusion on the classification of skin irritation. As, even under these more severe exposure conditions, only 1 from 4 rabbits (Marzin, 1978) or none from 6 rabbits (Worstmann, 1980) had mean irritation scores (mean for 24 -72 hrs) for erythema or oedema > 2.3, no classification results based on the criteria of EU Directive 1272/2008.
Eye irritation
Under test conditions comparable to OECD Guideline 405, acetophenone had no irritating effect on rabbit eyes (Key study: Worstmann, 1980; supporting study: Marzin, 1978). Indications of a possible irritation effect on rabbit eyes were reported in old, insufficiently documented studies (Smyth and Carpenter, 1944; Carpenter and Smyth, 1946), that are not comparable to the guideline conditions of the key studies and are therefore not adequate for classification. The more recent studies leading to no irritation are superseding the old study (quoted as reliability 4 according to Klimisch criteria) having lead to DSD Annex I classification as Xi R36.
Justification for selection of skin irritation / corrosion
endpoint:
Comparable to guideline study with acceptable deviations,
sufficiently documented; study acceptable as key study ((quoted as
reliability 2 according to Klimisch)
Justification for selection of eye irritation endpoint:
Comparable to guideline study with sufficient documentation; study
acceptable as key study (quoted as reliability 1 according to Klimisch)
Justification for classification or non-classification
According to EU regulation 1272/2008 no classification for skin irritation is justified, as mean irritation scores for erythema or oedema were significantly below the critical value of 2.3 even with a prolonged contact time of 24 hrs instead of the standard 4 hrs.
According to EU regulation1272/2008 there is no classification for eye irritation as no significant eye changes were observed in the key studies.
However as acetophenone is classified as Eye Irrit. 2 H319 in Annex VI of CLP Regulation, it shall be classified and labelled in accordance with this harmonised classification.
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