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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:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
This study was conducted prior to creation of the REACH regulation. The study was well documented and is sufficient for classification.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material was stored frozen.

FORM AS APPLIED IN THE TEST (if different from that of starting material):
The test material was brought to room temperature and administered as received.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HRP, Inc. Kalamazoo, MI
- Weight at study initiation: approximately 2112 g
- Housing: Animals were individually housed in screen-bottom cages in temperature- and humidity-c
ontrolled quarters
- Diet (e.g. ad libitum): ad libitum; Laboratory Rabbit Diet HF #5326, PMI Feeds, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
IN-LIFE DATES: From: 16 March 1994 To: 06 April 1994

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hour exposure period
Observation period:
21 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: Approximate exposure area of 6.25 cm2
- Type of wrap if used: The area of application was covered with a 2.5-cm x 2.5-cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® , and secured with Elastoplast ® tape to provide a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Exposure sites were washed with tap water.
- Time after start of exposure: 4 hours.

OBSERVATION TIME POINTS
30 minutes and 24, 48, 72, and 96 hours and days 7, 14, and 21

SCORING SYSTEM:
- Method of calculation: Draize method (1959).
(1) Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defiined eydthema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Highest possible erythema score 4

(2) Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges are well defined by raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised approximately 1 mm and extending beyond area of exposure) 4
Highest possible edema score 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: 1,2,3
Time point:
24/48 h
Score:
6.3
Irritant / corrosive response data:
Subcutaneous hemorrhaging, blanching, possible necrotic areas, desquamation, exfoliation, possible scar tissue and denuded areas were also observed. Irritation continued to be present in two animals at the day 21 observation.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Based on the results of the study, the test article is considered to corrosive to the skin under the conditions of this study.
Executive summary:

The objective of this study was to assess the relative level of primary skin irritation/corrosion of the test material under semioccluded conditions. The study was conducted according to the OECD 404 (1981).

Three albino rabbits (New Zealand White strain) each received 0.5 mL applications of the test article to an intact skin test site. The test sites were covered for 4 hours with a semi-occlusive dressing. The sites were evaluated for irritation at 30 minutes, 24, 48, 72 and 96 hours and 7, 14 and 21 days after removal of the test material. Application of the test article to the skin of albino rabbits under 4-hour semi-occluded conditions resulted in well-defined to severe erythema and moderate to severe edema

reactions. Subcutaneous hemorrhaging, blanching, possible necrotic areas, desquamation, exfoliation, possible scar tissue and denuded areas were also observed. Irritation continued to be present in two animals at the day 21 observation. A maximum average primary dermal irritation score of 6.3 out of a possible 8.0 was assigned at the 24- and 48-hour evaluations. Based on the results of the study, the test article is considered corrosive to the skin under the conditions of this study.