Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 April 2013 to 19 April 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
only moistened for good contact
Controls:
no
Amount / concentration applied:
0,5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours after removal of the pad
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
erythema score
Basis:
animal: #2. #3
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
A yellow coloration of the treatment site, not preventing erythema assessment, was noted in all animals between days 0 and 3. A very slight erythema was noted on the treated area in all animals 1 hour after the patch removal and was totally reversible between days 1 and 2. This reaction was associated in two animals with a very slight oedema noted 1 hour after the patch removal and totally reversible on day 1.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item does not have to be classified. No signal word or hazard steatement is required.