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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:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rabbit, New Zealand White, SPF

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Bidistilled water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Other effects:
COLORATION/IRRITATION/CORROSION:


Neither irritation, corrosion nor coloration of the treated
skin was noted throughout the study.



MORTALITY/CLINICAL SIGNS:

No mortality and no clinical signs observed.


BODY WEIGHTS:

The body weights of all animals were within the normal range
of variability.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Not classified
Executive summary:

The primary skin irritation potential of ucb22060was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores O). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore O. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no other clinical signs of test item related effects were observed. Thus, the test item did not induce significant or irreversible damage to the skin. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001 ), ucb 22060 is considered to be “not irritating” to rabbit skin.