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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was well performed and well documented. No OECD guideline was followed, however, the study is similar to the Draize test and the obtained scores can directly be interpreted for the classification according to the GLP regulation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
Deviations:
yes
Remarks:
occlusive dressing; 24 h application; examination of erythema and edema according to Draize only 24 h after application;
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-cyclohexyl-4-methylpentan-2-one
EC Number:
225-562-6
EC Name:
4-cyclohexyl-4-methylpentan-2-one
Cas Number:
4927-39-3
Molecular formula:
C12H22O
IUPAC Name:
4-cyclohexyl-4-methylpentan-2-one

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.0 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours after application
Number of animals:
6 for treatment on intact skin, 6 others for abraded skin
Details on study design:
TEST SITE
- Area of exposure: hairs were clipped, 2.5 x 2.5 cm
- Type of wrap: patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
- Abrasions: minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, only removal of patches
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Draize method for reading time point 24 h
A. Erythema and eschar formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)

B. Edema formation
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite)
3: Moderate edema (raised approximately 1 millimeter)
4: Severe edema (raised more than 1 millimeter and extending beyond the area of exposure)

CIVO-grading system, which comprises abnormalities of scaliness and/or necrosis for reading time point 72 h
0: No reaction at all
1: Very slight scaliness
2: Distinct scaliness or very slight incrustation
3: Distinct incrustation
4: Severe incrustation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2.67
Max. score:
4
Remarks on result:
other: Test item on intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
4
Remarks on result:
other: Test item on intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2.17
Max. score:
4
Remarks on result:
other: Test item on abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Remarks on result:
other: Test item on abraded skin
Irritation parameter:
other: scaliness/incrustation (CIVO-grading)
Basis:
mean
Time point:
72 h
Score:
1.8
Max. score:
4
Remarks on result:
other: Test item on intact skin
Irritation parameter:
other: scaliness/incrustation (CIVO-grading)
Basis:
mean
Time point:
72 h
Score:
1.8
Max. score:
4
Remarks on result:
other: Test item on abraded skin
Irritant / corrosive response data:
The test item caused moderate skin irritation. Its dermal effects generally consisted of very slight to well-defined erythema, very slight ischemia, focal haemorrhages, slight to distinct scaliness, slight incrustation and very slight edema.

Any other information on results incl. tables

Individual and average skin irritation scores

 

A. Intact skin

Rabbit

24 hours - erythema

24 hours - edema

72 hours - scaliness/incrustation

8803

4

1

2

8804

2

1

2

8805

4

1

2

8806

1

0

2

8807

1

0

1

8808

4

1

2

Average

2.67

0.67

1.8

 

B. Abraded skin

Rabbit

24 hours - erythema

24 hours - edema

72 hours - scaliness/incrustation

8797

4

1

2

8798

2

1

2

8799

1

1

2

8800

4

2

2

8801

1

1

1

8802

1

0

2

Average

2.17

1

1.8

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritant) based on CLP criteria
Conclusions:
On the basis of the present results it can be concluded that the test item is a moderate skin irritant.
Executive summary:

In the current study the test item was examined for skin irritation in New Zealand White albino rabbits. No OECD test guideline was followed, however the study is similar to the Draize test. The study was not GLP.

 

The test item was used undiluted and caused moderate skin irritation. Its dermal effects generally consisted of very slight to well-defined erythema, very slight ischemia, focal haemorrhages, slight to distinct scaliness, slight incrustation and very slight edema.

According to the CLP Regulation (EC) No 1272/2008 the main criteria for the skin irritant category is that at least 2 of 3 tested animals have a mean score of >= 2.3 - =< 4.0. In the present study 6 animals were tested, thus, by extrapolation 4 of 6 tested animals should have a mean score of >= 2.3 - =< 4.0. This is not the case. Nevertheless, the mean score for erythema after contact with the test item on an intact skin was 2.67. Therefore, in the current study the test item should be classified as moderately irriting.