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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 15, 1980 - July 17, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study similar to OECD Guideline 404. QA. Environmental conditions not reported. Acceptable basic data.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
3 male and female rabbits used; 4 skin sites (intact and abraded)/animal; observation time: 4, 24, and 48 hours
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 180-415
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually, in suspended wire bottom galvanize steel gages
- Diet: Purina rabbit chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: one week plus

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
4, 24, and 48 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 1" x 1"/site
- coverage: 4 skin sites/animal
- Type of wrap if used: surgical gauze patch, secured in place with strips of adhesive tape and wrapped with polyethylene film.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: The scoring criteria as described by Draize. Erythema and Eschar formation / Edema formation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
and eschar formation
Basis:
mean
Remarks:
6 animals: 4 skin sites/animal
Time point:
other: 4, 24 and 48 hours
Score:
ca. 0.84
Max. score:
1
Reversibility:
not fully reversible within: 48 hours
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 animals: 4 skin sites/animal
Time point:
other: 4, 24 and 48 hours
Score:
ca. 0.22
Max. score:
1
Reversibility:
not fully reversible within: 48 hours
Remarks on result:
other: intact and abraded skin
Irritant / corrosive response data:
Erythema and edema formation scores in tables. There were no signs of tissue destruction (ulceration or necrosis), or other dermal irritation or defects present on any test site at any of the observation times. The test material is not irritant or corrosive to the skin when treated on the intact and abraded skin of albino rabbits.

Any other information on results incl. tables

Scoring table: Erythema & Eschar formation, intact and abraded skin

Overall mean: 0.84 

 

Rabbit number and sex

 

 

 

 

 

 

 

 

 

 

 

LA intact skin

Mean

 

RA abraded skin

Mean

 

 

1M

2M

3M

4F

5F

6F

 

 

1M

2M

3M

4F

5F

6F

 

 

4-hour observation

1

1

1

1

1

1

1.00

 

1

1

1

1

1

1

1.00

 

24 hour observation

1

1

1

1

1

1

1.00

 

1

1

1

1

1

1

1.00

 

48 hour observation

0

0

1

1

1

0

0.50

 

1

0

1

1

1

0

0.67

 

 

LP intact skin

 

 

RP abraded skin

 

 

 

1M

2M

3M

4F

5F

6F

 

 

1M

2M

3M

4F

5F

6F

 

 

4-hour observation

1

1

1

1

1

1

1.00

 

1

1

1

1

1

1

1.00

 

24 hour observation

1

1

1

1

1

0

0.83

 

1

1

1

1

1

1

1.00

 

48 hour observation

0

0

1

1

1

0

0.50

 

1

0

1

1

1

0

0.67

 

LA          Left anterior test site – intact test site

RA         Right anterior test site – abraded test site

LP          Left posterior test site – intact test site

RP        Right posterior test site – abraded test site

Scoring table: Edema formation, intact and abraded skin

Overall mean: 0.22

 

Rabbit number and sex

 

 

 

 

 

 

LA intact skin

Mean

 

RA abraded skin

Mean

 

 

1M

2M

3M

4F

5F

6F

 

 

1M

2M

3M

4F

5F

6F

 

 

4-hour observation

0

0

0

0

0

0

0.00

 

0

1

1

1

1

1

0.83

 

24 hour observation

0

0

0

0

0

0

0.00

 

1

1

0

0

1

0

0.50

 

48 hour observation

0

0

0

0

0

0

0.00

 

0

0

0

0

0

0

0.00

 

 

LP intact skin

 

 

RP abraded skin

 

 

 

1M

2M

3M

4F

5F

6F

 

 

1M

2M

3M

4F

5F

6F

 

 

4-hour observation

0

0

0

0

0

0

0.00

 

0

1

1

0

1

0

0.50

 

24 hour observation

0

0

0

0

1

0

0.17

 

1

1

0

0

1

0

0.50

 

48 hour observation

0

0

0

0

0

0

0.00

 

1

0

0

0

0

0

0.17

 

LA          Left anterior test site – intact test site

RA         Right anterior test site – abraded test site

LP          Left posterior test site – intact test site

RP        Right posterior test site – abraded test site

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritant or corrosive to the skin when treated on the intact and abraded skin of albino rabbits. The average mean scores calculated from the numerical values given to the skin irritation observed at the 4, 24, and 48 hour examinations were 0.84 for erythema and 0.22 for edema. Based on these results and according to EU criteria the material was considered not irritating and the substance does not have to be classified according to the classification criteria outlined in 67/548/EEC and 1272/2008.
Executive summary:

A skin irritation and corrosion study was conducted, similar to OECD guideline 404, on 3 male and 3 female albino rabbits using the test material 180-415. There were 2 intact skin test sites and 2 abraded skin test sites per rabbit. Each test site was treated with 0.5 ml of actual undiluted test material and was occluded for 4 hours. Observations for dermal irritation or defects were made at 4, 24, and 48 hours after application of the tests material and reactions at the contact sites were graded. There were no signs of tissue destruction (ulceration or necrosis), or other dermal irritation or defects present on any test site at any of the observation times. The test material is not irritant or corrosive to the skin when treated on the intact and abraded skin of albino rabbits. The average mean scores calculated from the numerical values given to the skin irritation observed at the 4, 24, and 48 hour examinations were 0.84 for erythema and 0.22 for edema. Based on these results and according to EU criteria the material was considered not irritating and the substance does not have to be classified according to the classification criteria outlined in 67/548/EEC and 1272/2008.