Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
500 µl of the test substance placed on a plaster was applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Vorprodukt Katalysator WAZ 5596 B, brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.88
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Other effects:
Necrotic changes were seen in one animal. In all animals scab buidling after 14 days (erytema score = 4) was evident.

Any other information on results incl. tables

Due to the necrotic changes and scab building a classification as corrosive is justified.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

500 µl of the test substance placed on a plaster was applied on the skin of 3 rabbits. After 4 hours the plaster was removed and the exposed skin area was cleaned with water. Erythema/scab building and edema were scored according to Draize at 24, 48 and 72 hours.

For the erythema score a mean value (24, 48 and 72 h) of 2.33 (max. value = 4) and for the edema score a mean value (24, 48 and 72 h) of 0.88 was determined. Necrotic changes were seen in one animal. In all animals scab buidling after 14 days (erytema score = 4) was evident. Due to the necrotic changes and scab building a classification as corrosive is justified.