Registration Dossier

Diss Factsheets

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-compliant study. Adequate for assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
no data
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
CAN6
IUPAC Name:
CAN6
Test material form:
other: The test substance was moistened with sterile water in order to allow good contact between the test substance and the skin
Details on test material:
Appearance: White crystals.

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
Sex: Female.
Body weight: between 2.0 kg and 2.5 kg at the start of the experiment.
Feed and water were available ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: The test substance was moistened with sterile water
Controls:
other: Adjacent surfaces of untreated skin served as a control for the trial.
Amount / concentration applied:
0.5 g of the substance was applied on the skin of the righi flank region.
Duration of treatment / exposure:
each animal received one patch far an exposure period of four hours.
Observation period:
One hour, 24 hours, 48 hours and 72 hours approximately after removal of the dressing, any skin lesions, which ha ve developed on the right flank of each animal, w ere evaluated.
Number of animals:
3
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Score:
0
Remarks on result:
other: The score is related to 1, 24, 48 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #2
Score:
0
Remarks on result:
other: The score is related to 1, 24, 48 and 72 hours.
Irritation parameter:
erythema score
Basis:
animal #3
Score:
0
Remarks on result:
other: The score is related to 1, 24, 48 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #1
Score:
0
Remarks on result:
other: The score is related to 1, 24, 48 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #2
Score:
0
Remarks on result:
other: The score is related to 1, 24, 48 and 72 hours.
Irritation parameter:
edema score
Basis:
animal #3
Score:
0
Remarks on result:
other: The score is related to 1, 24, 48 and 72 hours.
Irritant / corrosive response data:
no data
Other effects:
no other effects were observed.

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions adopted, the substance was found to be non irritant for the skin of the rabbit.
Executive summary:

Under the experimental conditions adopted, the substance was found to be non irritant for the skin of the rabbit.

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