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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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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 material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material : FAT21'016/C
- Physical state: violet powder
- Analytical purity: 96 %
- Stability under test conditions: Stable at storage conditions.
- Storage condition of test material: at room temperature (ca. 20°C) away from direct sunlight.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN.Nr. 400047.32
- Expiration date of the lot/batch: December 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20 °C) away from direct sunlight.
- Stability under test conditions: Stable at storage conditions
- Stability of the test substance in the solvent/vehicle: Up to 24 hours bidistilled water

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65,D-88397 Biberach/Riss
- Age at study initiation:15 weeks
- Housing: Placed Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet : Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no.75/97)
- Water: Community tap water from Itingen, ad libitum, in water bowls.
- Acclimation period: Four days under test conditions after health examination.

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): As a solid, approximately 0.5 g (per animal) of the test article was weighed and then moistened with bidistilled water before application.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
Preparation:
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm) and the skin of the animals was examined.

TEST SITE
- Area of exposure: On the day of treatment, the test article was applied to approximately 6 cm2 of the intact skin of the clipped area.
- Type of wrap if used: It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
If evident, corrosive or staining properties of the test article were described and recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal No 7, 8 and 9
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal No 7, 8 and 9
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed

BODY WEIGHTS
The body weight of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 21016/C is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits according to OECD 404 and EU B4 guidelines. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 h) were used in calculating the respective mean values for erythema and edema. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 h and then dividing by the number of figures. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.00 edema. The test article caused violet or light violet staining of the treated skin. No irritating or corrosive effects were noted on the exposed skin of any animal at any measuring interval. Hence, FAT 21016/C is considered to be "not irritating" to rabbit skin.