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Toxicological information

Skin irritation / corrosion

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Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from Dec. 04, 1996 to Jan. 30, 1997
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guidelineopen allclose all
according to
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
according to
other: Directive 92/69 EEC, B.4. "Acute Toxicity - Skin Irritation", July 31, 1992.
GLP compliance:

Test material

Test material form:
other: solid
Details on test material:
Code number: FAT45'176/A
Batch No.: WP2/96
Purity: ca. 60 %
Appearance: orange-brown solid
Storage: room temperature
Expiration date: 11/2004

Test animals

New Zealand White
Details on test animals and environmental conditions:
Age at treatment: 15 weeks
Body weight at start of treatment: male : 2.5 kg, females: 3.2 kg
Acclimatization: Four days under test conditions after health examination. Only healthy animals were used for the study
Allocation: Male no. 4, Female nos. 5-6

Standard Laboratory Conditions:
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ± 3 °C and for relative humidity between 40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.

Test system

Type of coverage:
Preparation of test site:
bi-distilled water
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
Viability/Mortality: Daily
Clinical Signs: Daily during the observation period.
Body Weights: At the start of acclimatization, at the start of treatment and at termination of observation.
Irritation Scores: The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
Number of animals:
one male, two females
Details on study design:
The test article was moistened with bi-distilled water before application.
Approximately 24 hours 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.
Only those animals with no signs of skin injury or irritation were used in this test.
On the day of treatment, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 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. The test article was applied in such a position as to preclude oral ingestion after removal of the dressing.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

Results and discussion

In vivo

Irritation parameter:
overall irritation score
Time point:
other: 1, 24, 48 and 72 hours
Irritant / corrosive response data:
FAT 45’176/A showed a primary Irritation score of 0.00 when applied to healthy Intact rabbit skin.
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:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period and no mortality occurred.
Light orange staining by the test article of the treated skin was observed.
The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU
FAT45'176/A was 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 onto 6 cm2 intact dorsal skin of each of three young adult rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48,72 hours) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. Under the conditions of this experiment, FAT45'176/A was found to cause a primary irritation score of 0.00 (max. 8.0) when applied to healthy intact rabbit skin. Therefore, FAT45'176/A was not irritating to rabbit skin.