Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

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

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:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: gauze patches moistened with distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
Controls:
other: A control gauze patch was applied to the contralateral flank
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
control flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
test flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
control flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
test flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
control flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
test flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
control flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
test flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
control flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
test flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
control flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
test flank
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The TS has no primary skin irritation potency in albino rabbits.