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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Adequate details however 24 hour exposure; no COA; non-GLP. Needs test article id statement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: USA Federal Hazardous Substances Act (US-FHSA),
Deviations:
not specified
Principles of method if other than guideline:
USA Federal Hazardous Substances Act (US-FHSA),
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Cyclohexanone, peroxide
EC Number:
235-527-7
EC Name:
Cyclohexanone, peroxide
Cas Number:
12262-58-7
Molecular formula:
Multi-constituent substance (equilibrium mixture of a number of cyclohexyl based organic peroxides, hydrogen peroxide, cyclohexanone and water)
IUPAC Name:
Peroxycyclohexanone
Constituent 2
Reference substance name:
Cyclonox LE
IUPAC Name:
Cyclonox LE
Test material form:
other: colorless liquid
Details on test material:
None provided. Only trade name and physical form provided. The purity was not provided. However, it is assumed to be 21% based on the information provided in another acute report, conducted during the same time frame, at the same laboratory.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
None provided.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours after application
Number of animals:
Six rabbits are treated on intact ski and six on abraded skin
Details on study design:
Twelve healthy adult New Zealand White albino rabbits are used for 1-4 test substances. Twenty four hours prior to applying the materials, hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
An amount of 0.5 ml of the test substance is brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The 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.
Six rabbits are treated on the intact skin, the other six on the abrades. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or the product bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize (J. Pharmacol. 82 (1944) 377-390). A second reading is made 48 hours later (72 hours after application).
In the case of surface active test substances the skin reactions after 72 hours usually consist of scaliness and/or necrosis,. Since the Draize grading system does not comprise these abnormalities the second reading is carried out on the basis of the laboratory's own grading system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Erythema plus edema
Basis:
mean
Time point:
24 h
Score:
6.7
Max. score:
8
Reversibility:
other: No data reported
Remarks on result:
other: Intact skin
Irritation parameter:
overall irritation score
Remarks:
erythema
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
8
Reversibility:
other: No data reported
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Remarks:
erythema and edema
Basis:
mean
Time point:
24 h
Score:
6.8
Max. score:
8
Reversibility:
other: No data reported
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Remarks:
erythema
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
8
Reversibility:
other: No data reported
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
After 24 hours: distinct ischemia and slight or moderate edema.
After 72 hours: very slight to distinct scaliness or incrustation.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
The test substance is a severe to very severe primary skin irritant.
Executive summary:

The test article was evaluated for its potential skin irritation potential. The test article was applied to the intact and abraded skin of rabbits for 24 hours and the reactions scored according to the Draize method 24 and 72 hours following application.

The test article was severely irritating to rabbit skin.