Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Jun - Jul 04, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guideline for Testing of Chemicals No 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material CCH-3-on should not be classified as a skin irritant according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP. However, CCH-3-on revealed a long acting irritating potential in this study. Therefore, the test material exposure led to irritations up to the end of the study and should thus be handled with care.
Executive summary:

Purpose

The purpose of this assay was to identify the skin irritation/corrosion potential of CCH-3 -on when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.

Study Design

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with 2 further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily up to day 15 of the experimental phase.

Results

Erythema (scores 1 and 2) and edema (scores 1 and 2) were seen at the application sites from experimental day 1 up to experimental day 13. Strong redness around the application sites was observed from experimental day 6 up to experimental day 8.

Leathery skin at the application sites and around were observed from experimental day 6 up to experimental day 12 followed by the formation of scales up to the end of the experimental part of the study.

The evaluation of the mean scores of all animals is shown below:

Day 1 2 3 4

Erythma 1 1 1 1

Edema 1 1.33 0.33 0.33

Conclusion

The test material CCH-3-on should not be classified as a skin irritant according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP. However, CCH-3-on revealed a long acting irritating potential in this study. Therefore, the test material exposure led to irritations up to the end of the study and should thus be handled with care.