Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

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:
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 (as cited in study report): FAT 40'400/A
- Lot/batch No.: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
- Stability: Stable
- Stability of test article dilution: at least 2 hours

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: Males: 15 weeks, Female: 16 weeks
- Weight at study initiation: Males: 2.6 - 2.8 kg, Female: 3.0 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, batch 52/90 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:
shaved
Vehicle:
water
Remarks:
Test material was applied moistened in distilled water
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3; 2 males and 1 female
Details on study design:
Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration. On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the shaved 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 hours intervals after the removal of the dressing, gauze patch and test article.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary Irritation Score
Basis:
mean
Time point:
other: Average 24, 48, and 72 hours
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
Irritation: FAT 40'400/A showed a primary Irritation score (24,48,72 hours) of 0.00 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) 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 yellowish staining of the treated skin by pigment or coloring of the test article was observed in all animals between 1 to 72 hours (termination).
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.

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 experiment, the test substance was found to be not irritating or corrosive.
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 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 72 hours. The test substance showed a primary Irritation score (24,48,72 hours) 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, the test substance was found to be not irritating or corrosive.