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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:
25 Sep 1990 to 02 Nov 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
OECD Principles of Good Laboratory Practice, Paris, France

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 40'406/A
- Lot/batch No.: Vers. Nr. SR 6947/14
- Expiration date of the lot/batch: July 1995
- Stability: Stable
- Stability of test article dilution: at least 48 hours
- Storage: At room temperature, protected from light
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SR 6947/14.
- Expiration date of the lot/batch: July, 1995.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the original container, protected from light, at room temperature (approx. 20°C).
- Stability under test conditions: stable for at least 48 hours.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at start of treatment: Male: 15 weeks, Females: 16 weeks
- Weight at start of treatment: Male: 2.9 kg, Females: 2.9 - 3.1 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, batch 55/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen ad libitum
- Acclimation period: Four days under test conditions after veterinary examination

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
Test material was applied moistened in distilled water
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
up to 72 h
Number of animals:
3 (1 male and 2 females)
Details on study design:
Approximately 24 h before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. On test day 1, 0.5 g of the test article was applied to approximately 6cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed at 1, 24, 48 and 72 h intervals after the removal of the dressing, gauze patch and test article.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Irritation: FAT 40406/A showed a primary irritation score (24, 48, 72 h) of 0.00 when applied to intact rabbit skin. Local signs (mean 1 h to 72 h) consisted of grade 0.00 erythema and grade 0.00 edema.
Corrosion: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other effects:
Coloration: In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed during the observation period.
Body weights: The body weight gain of all rabbits was similar.
Toxic symptoms/mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

Any other information on results incl. tables

The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for the Irritant properties of a material, and they are viewed as reference values. The use of a semi-occlusive dressing is a severe test and the results are not directly comparable to human exposure conditions.


 


Necropsy:


The observation was terminated 72 hours after application of the test article. No necropsy was performed in the animals euthanized at termination of


observation. All rabbits were euthanized by an intravenous injection of T61 (Hoechst AG) into the ear vein and discarded.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40406/A was found to be not irritating or corrosive to skin.
Executive summary:

In a GLP-compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5 g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 h. After 4 h, the treated skin was flushed with water and observation were made for an additional 72 h. The test substance showed a primary irritation score (24, 48, 72 h) of 0.00 and local signs (1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No corrosive effect was evident on the skin. Under the conditions of this experiment, FAT 40406/A was found to be not irritating or corrosive to skin.