Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

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:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent untreated skin served as control
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Erythema and Oedema
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema and Oedema
Basis:
mean
Time point:
other: 1 day
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema and Oedema
Basis:
mean
Time point:
other: 2 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema and Oedema
Basis:
mean
Time point:
other: 3 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Erythema and Oedema
Basis:
mean
Time point:
other: 4 days
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:
A single semi-occlusive application of the TS to intact rabbit skin for four hours elicited no dermal irritation.