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Toxicological information

Skin irritation / corrosion

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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:
other: GLP-study according to OECD guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 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:
other: average 24, 48 and 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average 24, 48 and 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average 24, 48 and 72h
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.