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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:
From 29. Sep. 1987 to 02. Oct. 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madörin AG, 4414 Füllingsdorf, CH
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 2.6 to 2.7 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet: ad libitum; pelleted standard Kliba 341, batch 30/87 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Itingen (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 degrees
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hr
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Remarks:
electric clippers used 24 hours before treatment
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g solid
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Males: 2
Females: 1
Total: 3
Details on study design:
TEST SITE
- Shaved area: 100 cm² (10 cm x 10 cm)
- Area of exposure: 9 cm² (3 cm x 3 cm)
- Location: dorsal
- Type of wrap if used: surgical gauze

REMOVAL OF TEST SUBSTANCE
- Semi-occlusive dressing
- Test item removed and washed with lukewarm tap water 4 hours after application

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after application

SCORING SYSTEM:
- Colouration, corrosion and toxic symptom observations
- Irritation scores (both erythema score and oedema score):

ERYTHEMA AND ESCHAR FORMATION (Maximum possible score: 4)
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

OEDEMA FORMATION (Maximum possible score: 4)
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 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:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
IRRITATION
- Irritation scores for the test item (mean 24, 48 and 72 hours) were 0 for both erythema and oedema.

CORROSION
- No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other effects:
COLOURATION
- In the area of application slight black staining of the treated skin by pigment or colouring of the test item was observed after 1 hour in 2 rabbits. No rabbits demonstrated discolouration after 24 hours.

BODY WEIGHTS
- The body weight gain of all rabbits was similar.

TOXIC SYMPTOMS / MORTALITY
- No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

NECROPSY
- Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The test item was not found to be a skin irritant or a skin corrosive.
Executive summary:

Skin irritation potential of the test item was evaluated in an in vivo experimental study performed according to the OECD Guideline 404 (1987) and EU method B.4 (1984). 0.5 g of moistened, solid test item was applied to the shaved, dorsal area of three female rabbits for a duration of 4 hours. Observations of irritation (erythema and oedema scores; maximum score: 4) and corrosion (local destruction or corrosion) were recorded 1, 24, 48 and 72 hours after removal of the bandage. Animals were monitored for local discolouration (daily), toxic symptoms (daily) and body weight (end of study period).

Irritation scores (mean scores of 24, 48 and 72 hours) were 0 for both erythema and oedema for all animals. In the area of application, slight black staining of the treated skin by pigment or colouring of the test item was observed in 2 animals and was reversible within 24 hours. No corrosive effect, toxic symptoms or significant body weight differences were observed.