Registration Dossier
Registration Dossier
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EC number: 203-620-1 | CAS number: 108-83-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6-dimethylheptan-4-one
- EC Number:
- 203-620-1
- EC Name:
- 2,6-dimethylheptan-4-one
- Cas Number:
- 108-83-8
- Molecular formula:
- C9H18O
- IUPAC Name:
- 2,6-dimethylheptan-4-one
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Diisobutylketone
- Physical state: Colourless liquid
- Analytical purity: 96.1%
- Lot/batch No.: D226600037
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate
- Age at study initiation: 13-16 weeks
- Weight at study initiation: 2.39 to 2.70 kg
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40-80
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): Undiluted 96.1%
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72h and 8 (7 days after dosing) and 15 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 30x20mm
- Type of wrap if used: The dose was spread uniformly over the designated area and then covered by a dense gauze patch (30 x 20 mm). This in turn was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive bandage "Steroban" from Steroplast Ltd, Bredbury which was wrapped firmly around the torso to secure the applied dose and patch in the correct position.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, swabbed with moist cotton wool
- Time after start of exposure: 4h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- One week after treatment, the dermal test sites showed either a marked desquamation or very slight erythema. All overt effects of the semi-occluded topical application of diisobutylketone resolved within two weeks of treatment.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the study period.
Any other information on results incl. tables
A single semi-occluded application of diisobutylketone to intact rabbit skin for four hours elicited slight erythematous and oedematous reactions and other dermal changes (superficial eschar formation, tissuring and desquamation) that resolved within two weeks of treatment. Diisobutylketone has not to be classified according to DSD and CLP.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, DIBK was concluded as not irritating to semi-occluded rabbit skin. Mean scores for erythema and edema were 1.33, 0, 0.33 and 1.0, 0, 0 for animals 1, 2 and 3, respectively.
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