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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
Study period:
January 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
UVCB
Specific details on test material used for the study:
Batch 9000343808

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48 and 72 hours and 7, 14 days after application.
Number of animals:
3 (one male and two females)
Details on study design:
The primary irritation score was calculated to reflect and classify the irritant potential of the test article.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Primary Irritation Score
Score:
3.44
Max. score:
8
Reversibility:
fully reversible within: 14d
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Executive summary:

Application of Cedrene Washed to healthy intact rabbit skin resulted in a primary irritation score of 3.44.

Therefore Cedrene Washed is considered to be "Irritating" to rabbit skin.