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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Animal study from the period before entry into force of the in-vitro skin irritation requirement.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was subject to the EPA Guidelines for Good Laboratory Practice Standards 40 CFR Parts 160 & 792. The test method was performed according to the internationally accepted EPA guideline 81-5. Test substance data lacked purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: Suttocide®A- Appearance: white powder- Lot/batch No.: Not specified- Purity: Not specified- Sample praparation: The test article was weighed, applied to the site on the rabbit and covered with a gauze patch moistened with distilled water.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA - Quarantine period of at least one week.- Sex: males- Weight at study initiation: 2.0 -2.2 kg.- identification: cage notation and a uniquely numbered metal eartag.- Housing: individually in wire-meshed cages with bedding. - Diet: Fresh Purina Rabbit Chow (Diet #5321).- Water: ad libitum.- Identification: ear tags and color coded cage cards- Animal room: reserved exclusively for rabbits on acute tests, temperature controlled with a 12 hour light/dark cycle, and kept clean and vermin free.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
5 % or 0.5 %
Controls:
not required
Amount / concentration applied:
100% -Test substance as such
Duration of treatment / exposure:
4h
Observation period:
72 h in total
Number of animals:
6
Details on study design:
TEST SITE- Clipping: The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site was approximately 1 O x 15 cm and remained intact. - Application: TEST SUBSTANCE:- 0.5 g of the test article was placed under a 2.5 x 2.5 cm, moistened 4 ply, surgical gauze patch. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.SCORING:- The test sites were scored for dennal irritation at 30 to 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours following patch removal. - Erythema and edema were scored according to the numerical Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. EVALUATION:Erythema & Eschar:- 0= No erythema - 1= Very slight erythema (barely perceptible) - 2= Well defined erythema - 3= Moderate to severe erythema - 4= Severe erythema (beet redness) to slight eschar formation (injuries in depth) Edema: - 0= No edema - 1= Very slight edema (barely perceptible) - 2= Slight edema (edges of area well-defined by definite raising) - 3= Moderate edema (raised approximately 1.0 mm) - 4= Severe edema (raised more than 1.0 mm, extending beyond the area of exposure)- In evaluating the average irritation, scores for individual intact and abraded exposure sites were recorded separately for each of the two scoring time intervals. A total for erythema and eschar formation was added to a total for edema then divided by 4 to yield the individual animal score. - The mean of the three scores was calculated and this score represents the mean primary irritation score. Analysis of Data:- Dermal irritation is the production of reversible inflammatory changes in the skin following exposure to the test article. - Dermal corrosion is the production of irreversible tissue damage to the skin fallowing exposure to the test article.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 minutes
Score:
0.5
Remarks on result:
other: Individual scores: 0;0;0;1;1;1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
0.33
Remarks on result:
other: Individual scores: 0,0,0,1,0,1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 + 72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: Individual scores: 0; 0; 0; 0; 0; 0.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30 - 60 minutes
Score:
0.17
Remarks on result:
other: Individual scores: 0;0;0;0;0;1.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 + 48 + 72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: Individual scores: 0;0;0;0;0;0.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Suttocide®A was determined to be slightly irritating to the skin of rabbits, when administered as such.