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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:
26 Feb - 02 Mar 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
yes
Remarks:
several test substance concentrations were applied on one animal
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Jan 1997
Deviations:
yes
Remarks:
several test substance concentrations were applied on one animal
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: SPF albino rabbits
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.8 - 3.0 kg
- Housing: individually in PPO cages
- Diet: Altromin 2123 (Altromin, Lage, Germany), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to ph 2.5, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: for test substance concentrations of 1, 10, 25 and 50% ethanol/diethylphthalat (1:1) was used as vehicle
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentrations: 1, 10, 25, 50 and 100%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Reading time points: 1, 24, 48 and 72 hours
Number of animals:
4 females
Details on study design:
TEST SITE
- Area of exposure: 10 x 10 cm on the back (divided into six fields)
- Type of wrap: The test substance or vehicle was applied to 16-layer gauze patches (2.5 x 2.5 cm) and the patches placed on the appropriate test sites on the back of each rabbit. The gauze patches were secured with adhesive Gothaplast tape (2.5 cm wide) and fixed with Gothaplast tape (5 cm wide) loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: After application the skin sites were cleaned with mild soap and lukewarm water.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #2, #3 and #4
Time point:
other: mean after 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: test concentration: 100%
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: test concentration: 100%
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversiblitiy: not applicable
Remarks on result:
other: test concentration: 100%
Irritant / corrosive response data:
One hour after termination of exposure none of the 4 animals showed skin reactions at any concentration. 24 hours after termination of exposure a very slight erythema (score 1) was observed in all animals at 100%. 48 hours after termination of exposure a very slight erythema (score 1) was observed in one animal at 100%. The other animals were free of any signs of skin irritation after 48 hours at 100%. No skin reactions were observed at 1, 10 and 50% test substance concentration at any reading time point. Only very slight erythema (score 1) was observed in one animal 24 hours after removal of the patch at 25% test substance concentration. The animal was free of signs after 48 hours.

Any other information on results incl. tables

Table 1: Individual skin examination scores with the undiluted test substance

Skin effect

Erythema

Edema

Scoring

24h

48h

72h

Meana

24h

48h

72h

Meana

Animal 1

1

1

0

0.67

0

0

0

0

Animal 2

1

0

0

0.33

0

0

0

0

Animal 3

1

0

0

0.33

0

0

0

0

Animal 4

1

0

0

0.33

0

0

0

0

aMean of 24, 48 and 72 h scores

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this skin irritation study in rabbits the undiluted test substance (100%) was not irritating to the skin. Also the test substance concentrations of 1, 10, 25 and 50% in ethanol/diethylphthalat (1:1) did not show an irritation potential.