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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Ceraphyl 55
- Supplied by: International Specialty Products
- Data received: 01/28/04
- Storage: Room temperature and humidity
- Description: Clear light yellow liquid
- Sample preparation: The test article was used as received

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Supplied on: 02/04/04
- Date of birth: 11/09/03 and 11/16/03
- Weight at study initiation: 2.5-2.7 for females
- Housing: Suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): Free available
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C) and humidity: controlled
- Photoperiod (hrs dark / hrs light): 12 hr light/12 hr dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml/site
Duration of treatment / exposure:
4 hours
Number of animals:
1 male and 2 females rabbits
Details on study design:
The dorsal area of the trunk of each animal was clipped free of hair. The test site was approximately 10x10 cm.
The day after the preparation, 0.5 ml/site of the test article was applied under a 2.5x2.5 cm, 4 ply surgical gauze patches. The patch was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. A layer of extra tape covered the plastic in order to prevent displacement and possible evaporation of the test article.
The test material stayed in contact with the skin of the animals for 4 hours at which time, the wrapping was gently removed and the skin was gentle washed with distilled water.
The test sites were scored for dermal irritation at 60 minute, 24, 48 and 72 hour time points. Erythema and edema were scored according to the numerical Draize score. Any areas of ulcerations, necrosis and tissue damage was also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No mortaly occurred
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
#2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No mortality occurred
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
other: 60 minutes
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No mortality occurred
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 60 minutes
Score:
0
Max. score:
0
Remarks on result:
other: No mortality occurred
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No mortality occurred

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article Ceraphyl 55 is not irritating under test conditions.
Executive summary:

The test material Ceraphyl 55 was tested on 1 male and 2 female New Zealand White rabbits. A volume of 0.5 ml of the test article was applied to a patch and placed to the dorsal area of the trunk of each animal. The test site was secured with a non-irritant adhesive and the torso of the animal was wrapped with plastic in a semi-occlusive manner. The test material stayed in contact with the skin of the animals for 4 hours. The skin treated was scored for erythema and edema at 60 minute, 24, 48 and 72 hour time points according to the numerical Draize score. Any evidence of ulcerations, necrosis and tissue damage was also recorded. The result of the test shows erythema and edema score of 1 in 2 and 3 animals respectively at 60 minute time point. The dermal irritation was fully reversible within 24 hours. At 24, 48, 72 hour time points, the erythema and edema scores were 0 in all animals. In conclusion, the test material Ceraphyl 55 is considered to be not irritant under the condition of this test.