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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:
14 January 1986 to 17 January 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3 male and 3 female rabbits

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5g of the test material.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
Test material (0.5g) was applied to the shaved skin of 3 male and 3 female rabbits, moistened with water and covered by a gauze pad, which was held in place by a tape for 4 hours. Collars prevented the rabbits from ingesting the test article. After the exposure period the test article was removed with a moist paper towel. One hours after removal of the gauze pad and 24, 48 and 72 hours after the application of the test article the skin reaction was scored according to the Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable - no reactions observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable - no reactions observed.
Irritant / corrosive response data:
No signs of dermal irritation were noted at any observation time.
Other effects:
None.

Any other information on results incl. tables

No signs of dermal irritation were noted at the 1, 24, 48 or 72 hour time points.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No signs of dermal irritation were noted at the 1, 24, 48 or 72 hour time points and it was concluded that benoxacor was not irritant to the skin of rabbits.
Executive summary:

A single topical application of 0.5g of benoxacor to the shaved skin of six NZW rabbits under an occluded dressing resulted in no signs of dermal irritation at any of the assessment time points. It was concluded that benoxacor was not irritating to the skin of rabbits.