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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable deviations (multi patch study was performed with more than one chemical tested per animal, short observation period)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Reference Type:
publication
Title:
Unnamed
Year:
1996
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(multi patch study was performed with more than one chemical tested per animal)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 97.8%

Test animals

Species:
rabbit
Strain:
other: New Zealand White Albino
Details on test animals and environmental conditions:
TEST ANIMAL
- Housing: individually
- Diet: ad libitum, (S.Q.C. Standard Rabbit Diet, Special Diet Services Limited, Witham, Essex)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 40-80
- 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): 0.5 ml applied on lint patches
- Concentration (if solution): undiluted (100%)
Duration of treatment / exposure:
4h
Observation period:
7d
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: flank, immediately caudal to the last rib
- Type of wrap: 'Elastoplast' elastic adhesive bandage 10cm wide
- Restraining of animals: Yes

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing of site with cotton wool soaked in warm water
- Time after start of exposure: 4h

SCORING:
- Scoring time: at least 1h, 24h, 48h, 72h, 7d after removal of patch

Scoring system: Draize scoring system
Erythema and Eschar Formation
- No erythema = 0
- Very slight erythema (barely perceptible) = 1
- Well-defined erythema = 2
- Moderate to severe erythema = 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4.

Oedema Formation
- No oedema = 0
- Very slight oedema (barely perceptible) = 1
- Slight oedema (edges of area well-defined by definite raising) = 2
- Moderate oedema (raised approximately 1 mm) = 3
- Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h;48h; 72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Marked desquamation present in all 3 animals after 7 days. Slight erythema in one animal and well-defined erythema in 2 animals still present after 7 days observation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h;48h; 72;
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Slight edema still present in 2 animals after 7 days
Irritant / corrosive response data:
For assessment of the skin irritation, the mean score for all animals at time points 24, 48 and 72 h was used. The scores of each of the 3 animals for the time points 24, 48 and 72h were summed and divided by the 3, the number of examinations that the figures were taken from. The mean value for each of the 3 animals was summed and divided by 3 for the number of animals from which the values were taken from. The values obtained on assessing oedematous reaction were similarly treated.

Any other information on results incl. tables

Table 1: Summary of results of skin irritation study in rabbit

Readings

Animal

Erythema

Edema

Further findings

1h

1

0

1

2

2

2

3

1

2

24h

1

1

2

2

2

2

3

2

3

48h

1

2

2

2

2

3

3

2

3

72h

1

2

2

2

2

3

3

3

3

7d

1

1

0

Marked desquamation

2

2

2

Marked desquamation

3

2

2

Marked desquamation

Mean (24h-72h)

1

1,7

2,0

2

2,0

2,7

3

2,3

3,0

Mean (24h-72h)

all animals

2,0

2,6

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information