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Administrative data

Description of key information

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

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Reason / purpose for cross-reference:
reference to same study
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
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.
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
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.

no data

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Key study performed under GLP condition.

Justification for classification or non-classification

According to CLP Regulation, the substance was classified as not hazardous for the class Skin irritation/corrosion.

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