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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:
Apr 2, 1982 - May 24, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report. Restriction due to the animals were exposed to the test item for 24 h

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Section 1500.41 – Federal Hazardous Substances Act Regulation – 16 CFR – p.124.
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
The test substance was held in contact with skin for 24 hours.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Albino rabbit; strain unknown
Details on test animals and environmental conditions:
- Source: Techboard, Shepherd Products Company
- Housing: Stainless steel cages with elevated wire mesh flooring, 1 rabbit/cage.
- Diet: Wayne 15 % Rabbit Ration was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
- Acclimation period: no data available.

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70 +/- 2.
- Humidity (%): 45 % +/- 5 %.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
The test substance was administered once per site and remained in contact with the skin for 24 hours.
Observation period:
The skin was examined and graded for dermal reaction following and 72 hours after patch removal.
Number of animals:
Six rabbits
Details on study design:
TEST SITE
-One side of the animals’ backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
-0.5 mL of test material was applied to an abraded and an intact skin site on the same rabbit. Gauze patches were then placed over the treated and an impervious material was wrapped around the trunks of the animals to hold the patches in place.

SCORING SYSTEM:
Dermal Irritation was graded in accordance with the Draize method of scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0.17
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0.17
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.17
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.17
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
Total score = 3.34
Primary Irritation Score = 3.34/4 = 0.84

Any other information on results incl. tables

Table 1. Erythema and Eschar Formation

 

Site

 

Hour

Animal

 

Average

1

2

3

4

5

6

Intact skin

24

1

1

1

1

1

1

1.00

72

0

0

1

0

0

0

0.17

Abraded skin

24

1

1

1

1

1

1

1.00

72

0

0

1

0

0

0

0.17

Subtotal

2.34

Table 2. Edema Formation  

 

Site

 

Hour

Animal

 

Average

1

2

3

4

5

6

Intact skin

24

0

1

1

0

0

0

0.33

72

0

0

1

0

0

0

0.17

Abraded skin

24

0

1

1

0

0

0

0.33

72

0

0

1

0

0

0

0.17

Subtotal

1.00

 

Total score = 3.34

Primary Irritation Score = 3.34/4 = 0.84

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Primary Irritation Score = 3.34/4 = 0.84
Executive summary:

The primary dermal irritation potential of the test material was evaluated in this study with albino rabbits. A single 0.5 mL dose of the test material was applied to an abraded and an intact site on each animal's back. All doses were wrapped with an impervious material dressing for a 24 hour exposure period. At completion of exposure the bandages were removed, and application sites were evaluated in accordance with the method of Draize at approximately 24 and 72 h following patch removal.

The Primary Irritation Index was calculated to be 0.84 for sites treated with the test material.