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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test is done under GLP and following OECD Guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
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:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.0 kg
- Housing: individually in metal cages
- Diet (ad libitum): Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (ad libitum): drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined, total obervation time: 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape (BLENDERM), wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM:
according to Draize and guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24,48,72 h
Score:
2
Max. score:
4
Reversibility:
other: erythema fully reversible within 14 days, but other skin effects
Remarks on result:
other: effects after 14 days: keratinolysis, reduced re-growth of fur, straw-coloured crust
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24,48,72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: effects after 14 days: dried blood, thickening of skin, scar tissue, straw-coloured crust
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: effects after 14 days: dried blood, thickening of skin, scar tissue, straw-coloured crust
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: effects after 14 days: thickening of skin, scar tissue, straw-coloured crust
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: effects after 14 days: dried blood, thickening of skin, scar tissue, straw-coloured crust
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: effects after 14 days: keratinolysis, reduced re-growth of fur, thickening of skin, scar tissue, straw-coloured crust
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: reactions extending beyond site of application
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: reactions extending beyond site of application
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: reactions extending beyond site of application
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: reactions extending beyond site of application
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: reactions extending beyond site of application
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
other: unclear due to other skin effects
Remarks on result:
other: reactions extending beyond site of application
Irritant / corrosive response data:
Effects after 4 h of exposure:
Severe dermal responses were produced. The adverse skin reactions sometimes precluded accurate evaluation of erythema and oedema.
The reactions were identified as well-defined erythema, severe oedema, haemorrhage of the dermal capillaries, a brown discolouration of the epidermis, blanching of the skin, white raised areas of skin, scabbing, loss of skin elasticity, a dry straw-coloured crust (possible hyperkeratinisation), thickening of the skin, reduced re-growth of fur and glossy skin. Scar tissue, indicative of dermal corrosion was noted in five rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material was corrosive to the skin of rabbits
Executive summary:

Six New Zealand rabbits were treated with the test substance in an dermal irritation/corrosion study according to guidelines OECD 404 and EU B.4. The test substance produced erythema with a mean score of 2 and edema with a mean score of 2.2. After 4 h of exposure, severe dermal responses were produced. The adverse skin reactions sometimes precluded accurate evaluation of erythema and oedema. The reactions were identified as well-defined erythema, severe oedema, haemorrhage of the dermal capillaries, a brown discolouration of the epidermis, blanching of the skin, white raised areas of skin, scabbing, loss of skin elasticity, a dry straw-coloured crust (possible hyperkeratinisation), thickening of the skin, reduced re-growth of fur and glossy skin. Scar tissue, indicative of dermal corrosion was noted in five rabbits. Under the conditions of this study the test material was corrosive to the skin of rabbits.