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Description of key information

FEX0-080 was found to be non irritant on 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:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to recommended guidelines.
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
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Acclimatization: For at least 5 days before the treatment, in the area where the experiment took place. Housing: Animals were housed individually in cages of standard size. Excreta were removed by unrolling plasticized brown paper, previously placed under cages. These cages were placed in an air conditioned (17- 21°C) animal house kept at between 45 % and 65 % relative humidity in which non-recycled filtered air was changed approximately ten times per hour. The artificial day/night cycle was 12 hours light and 12 hours darkness with light on at 7.30 a. m.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
sterile
Controls:
no
Amount / concentration applied:
0.5 g of FEX0-080 was applied.
Duration of treatment / exposure:
3 minutes and 1 hour for the first animal.
4 hours for the other ones.
Observation period:
One hour, 24 hours, 48 hours and 72 hours approximately after removal of the dressing, any skin lesions, which may have developed on the right flank of each animal, was evaluated.
Number of animals:
Three animals were treated.
Details on study design:
Three animals are required for the complete test. Additional animals may be used to clarify equivocal responses. In case FEX0-080 shows corrosive properties in the first animal the test can be stopped at this stage. Animals will be selected on the basis of their general conditions.

Exposure of one animal:
If it is suspected that the test substance may produce severe irritancy/corrosion to the skin, then initially a single rabbit will be treated. When it is suspected that the test substance may cause corrosion, three test patches will be applied successively to separate skin sites on the animal. A first patch will be removed after three minutes. If no severe skin reaction is observed, a second patch will be applied and removed after one hour. If the observations at this stage indicate that exposure can humanely be allowed to extend to four hours, a third patch will be applied and removed after four hours and the responses will be graded. If a corrosive effect is observed after one of the three sequential exposures, the study will achieve immediately. When it is suspected that the test substance may cause severe irritancy (not corrosion), a single patch will be applied to the animal for four hours.

Exposure of two additional animals:
If neither a corrosive effect or a severe irritant effect is observed after four hours exposure, the test will be completed using two additional animals, each with one patch only, for an exposure period of four hours. Exposure of three animals: I fit is suspected that the test substance will not produce severe irritancy or corrosion, the study may be started using three animals, each receiving one patch for an exposure period of four hours.

The number of animals per group is the minimum number enabling an accurate assessment of the studied toxicological effect.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour - 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour - 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour -24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour - 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 hour - 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 hour - 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 hours - 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 hours - 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 hours - 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 hours - 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 48 hours - 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 hours - 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Acute skin lesions - Individual scores
Irritant / corrosive response data:
Under the experimental conditions adopted, FEX0-080 was found to be non irritant on rabbit.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions adopted, FEX0-080 was found to be non irritant on rabbit.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified as skin irritant.
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

Skin irritant was evaluated on rabbit according to OECD 404 Guideline. Under the experimental conditions adopted, FEX0-080 was found to be non irritant.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified as skin irritant.