Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline No. 404 EC Directive 92/69/EEC Annex V Test B.4
GLP compliance:
yes

Test animals

Species:
other: New Zealand white rabbits.

Test system

Type of coverage:
semiocclusive
Vehicle:
other: SNEA applied as supplied.
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:
other: overall at 24, 48 and 72 h
Score:
1.33
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Irritation parameter:
erythema score
Max. score:
2
Remarks on result:
other: Max. duration: 48 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Irritation parameter:
edema score
Max. score:
2
Remarks on result:
other: Max. duration: 48 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 27 days
Other effects:
Test site hardening and thickening was noted in 2 animals24h after patch removal. Scabbing was noted at the testsite of the remaining animal 72h after patch removal.No animal had fully recovered by the end of the observationperiod. Skin at the test site was thickened, hardened andscabbed up to the end of the observation period 27 daysafter patch removal. On the basis of the test sitehardening and scabbing, SNEA has been classified as anirritant.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information