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EC number: 204-626-7 | CAS number: 123-42-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before the implementation of the REACH regulation
Test material
- Reference substance name:
- 4-hydroxy-4-methylpentan-2-one
- EC Number:
- 204-626-7
- EC Name:
- 4-hydroxy-4-methylpentan-2-one
- Cas Number:
- 123-42-2
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 4-hydroxy-4-methylpentan-2-one
- Details on test material:
- - Name of test material (as cited in study report): DIACETONE ALCOHOL.
- Physical state: Colourless liquid.
- Analytical purity: 99.72%.
- Lot/batch No.: 9609P0513.
- Expiration date of the lot/batch: October 1997.
- Stability under test conditions: Not reported.
- Storage condition of test material: At room temperature and protected from light.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d'Elevage Lebeau, 78950 Gambais, France.
- Age at study initiation: Approximately 3 months old.
- Weight at study initiation: 347 ± 31 g (males); 373 ± 20 g (females).
- Housing: Housed individually in polycarbonate cages.
- Diet (e.g. ad libitum): 106 diet (U.A.R., 91360 Villemoisson-sur-Orge, France), ad libitum.
- Water (e.g. ad libitum): Filtered by a F.G. Millipore membrane (0.22 micron), ad libitum.
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 30 to 70
- Air changes (per hr): About 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 %
- Day(s)/duration:
- single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- single
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: See Any other information on materials and methods.
- Concentration / amount:
- -Intradermal induction: 25% (w/w) in sterile isotonic saline solution (0.9% NaCl).
-Epicutaneous induction: Undiluted.
-Cutaneous challenge: Undiluted.
II) Challenge period: undiluted test substance
- No. of animals per dose:
- Control group: 5/sex.
Test substance group: 10/sex. - Details on study design:
- RANGE FINDING TESTS: A preliminary test was conducted in order to determine the concentrations to be tested in the main study.
A preliminary test was conducted in order to determine the concentrations to be tested in the main study.
Preparation of the animals:
For all animals and before each treatment, the application sites were:
-clipped on Days -1 and 7 (scapular area 4 cm x 2 cm),
-clipped and shaved on Day 21 (each flank 2 cm x 2 cm).
I) Induction phase by intradermal and cutaneous routes
1) Intradermal route
On Day 1, six injections were made deep into the dermis of a clipped area (4 cm x 2 cm) in the dorsal region between the shoulders, using a needle mounted on a 1 mL glass syringe.
Three injections of 0.1 mL were made into each side of this shoulder region, as follows:
Treatment group:
A) Anterior: Freund's complete adjuvant diluted at 50% (v/v) with sterile isotonic saline solution (0.9% NaCl)
B) Middle: test substance at 25% (w/w) in 0.9% NaCl
C) Posterior: mixture of 50/50 (w/v) of A and B
Control group:
A) Anterior: Freund's complete adjuvant diluted at 50% (v/v) with 0.9% NaCl
B) Middle: vehicle (0.9% NaCl)
C) Posterior: mixture of 50/50 (w/v) of A and B
2) Cutaneous route
On Day 7, the scapular area was clipped. As the test substance was shown to be non-irritant during the preliminary tests, the animals were treated with 0.5 mL of sodium lauryl sulfate (10% w/w) in vaseline in order to induce local irritation.
On Day 8, a topical application to the region of the intradermal injections was performed.
Control group:
Application of 0.5 mL of the vehicle
Treatment group:
Application of 0.5 mL of the test substance undiluted.
The test substance and the vehicle were prepared on a dry gauze pad, which was then applied to the dorsal region between the shoulders and held in place for 48 hours by means of an adhesive hypoallergenic dressing and an adhesive anallergenic waterproof plaster. No residual test substance was observed after removal of the dressing. Cutaneous reactions were recorded one hour after removal of the occlusive dressing.
II) Challenge phase
On Day 22, the animals from both groups received an application of 0.5 mL of the test substance undiluted to the posterior right flank, and 0.5 mL of the vehicle to the posterior left flank. This application was performed using a 1 mL glass syringe. The test substance and the vehicle were prepared on a dry gauze pad, then applied to a 4 square cm clipped area of the skin. The gauze pad was held in contact with the skin for 24 hours by means of occlusive, hypoallergenic dressing and an adhesive anallergenic waterproof plaster. No residual test substance was observed after removal of the dressing.
Twenty-four and 48 hours after the challenge application, both flanks of the treated and control animals were observed in order to evaluate cutaneous reactions, according to the following scale:
Erythema and eschar formation: Grade
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema: Grade
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (visible swelling with well-defined edges): 2
Moderate oedema (visible swelling raised more than 1 mm): 3
Severe oedema (visible swelling raised more than 1 mm and extending beyond the area of exposure): 4
Any other lesions were noted.
Clinical examinations: The animals were observed twice a day during the study in order to check for clinical signs and mortality.
Body weight: The animals were weighed individually on the day of allocation into the groups, on the first day of the study (Day 1), on Days 8 and 15 and on the last day of the study (Day 25). - Challenge controls:
- See details on study design.
- Positive control substance(s):
- yes
- Remarks:
- 2,4-Dinitro Chlorobenzene
Results and discussion
- Positive control results:
- Under the experimental conditions and according to the Magnusson and Kligman method, the test substance 2,4-Dinitro Chlorobenzene at a concentration of 0.5% (w/w) induced positive skin sensitization reactions in 50% of the guinea-pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No cutaneous reactions were observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No cutaneous reactions were observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No cutaneous reactions were observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No cutaneous reactions were observed.
- Reading:
- other: 1st reading: right flank
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No cutaneous reactions were observed
- Remarks on result:
- other: Reading: other: 1st reading: right flank. . Hours after challenge: 24.0. Group: negative control. Dose level: Undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No cutaneous reactions were observed.
- Reading:
- other: 2nd reading: right flank
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No cutaneous reactions were observed
- Remarks on result:
- other: Reading: other: 2nd reading: right flank. . Hours after challenge: 48.0. Group: negative control. Dose level: Undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No cutaneous reactions were observed.
- Reading:
- other: 1st reading: left flank
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.9% NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No cutaneous reactions were observed
- Remarks on result:
- other: Reading: other: 1st reading: left flank. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.9% NaCl. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No cutaneous reactions were observed.
- Reading:
- other: 2nd reading: left flank
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.9% NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No cutaneous reactions were observed
- Remarks on result:
- other: Reading: other: 2nd reading: left flank. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.9% NaCl. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No cutaneous reactions were observed.
- Reading:
- other: positive control not applied in the test
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of the test substance diacetone alcohol were observed in guinea-pigs.
- Executive summary:
The skin sensitization potential of diacetone alcohol was assessed in a study performed according to OECD Guidelines for the Testing of Chemicals No. 406 and in compliance with GLP in male and female Dunkin-Hartley guinea pigs (de Jouffrey, 1997). In the main study, 10 animals/sex comprised the diacetone alcohol test group and 5 animals/sex comprised the vehicle control group. The intradermal induction was carried out with 0.1 mL of 25% (w/w) of diacetone alcohol in vehicle (a solution of 0.9% w/v of NaCl), and epicutaneous induction was performed with 0.5 mL of undiluted diacetone alcohol to the dorsal area under occlusive conditions. The challenge exposure also was conducted with 0.5 mL of undiluted diacetone alcohol. Additionally, all animals were dermally exposed to 0.5 mL of 10% w/w sodium lauryl sulphate (SDS) in vaseline 24 hours prior to topical sensitization of the skin area in order to induce local irritation (diacetone alcohol was shown to be non-irritating in the preliminary test). Skin reactions were observed and recorded 1 hour after dermal and 24 and 48 hours after the challenge exposure, all according to the grading scale by Magnusson and Kligman. Test and control animals displayed normal body weight gain throughout the investigation and no mortalities or clinical signs were observed. On Day 10, following dermal induction, signs of irritation were observed at the site of application in both control and treated groups. Following the challenge exposure, no incidences of erythema or oedema were observed, either at 24 or 48 hours, in all animals. Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of diacetone alcohol were observed in guinea-pigs. Therefore, the results of this study demonstrated that diacetone alcohol showed no evidence of contact skin sensitization in guinea pigs.
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