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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:
Dec. 04, 1996 to Jan. 30, 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)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
German GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: WP2/96
- Expiration date of the lot/batch: November 30, 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (ca. 20°C) away from light.
- Stability under test conditions: stable at storage conditions
- Stability of the test substance in the solvent/vehicle: Stable for at least 48 h in 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
- Weight at study initiation: male : 2.5 kg; females: 3.2 kg
- Housing: 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 (batch 71/96) ad libitum from Kliba Mühlen AG, CH-4303 Kaiseraugst
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: Four days under test conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-709
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: December 9-12, 1996

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
electric clipper
Vehicle:
water
Remarks:
bi-distilled water
Controls:
not specified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h.

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 h 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 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.
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 h. 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animal
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:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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:
GHS criteria not met
Conclusions:
FAT45'176/A was not irritating to rabbit skin.
Executive summary:

The primary skin irritation potential of FAT 45176/A was investigated in New Zealand White rabbits according to OECD 404 and EU B.4 guideline.

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. Only those animals with no signs of skin injury or irritation were used in the test. On the day of treatment, 0.5 g of the test article was applied to approx. 6 cm2of 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 h. 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.

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 hours) were used in calculating the respective mean values for each type of lesion.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. However, 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.

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 (Edema and erythema score ‘0’). Therefore, FAT45'176/A was not irritating to rabbit skin.