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Diss Factsheets

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:
June 24 to July 14, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test experiment was performed under GLP conditions and according to OECD Guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
Identification : FAT40'815/A
Description : Dark shining powder
Batch number : WP 8/03
Purity : Approx. 75%
Stability of test item : Stable under storage conditions
Expiry date : 01-MAY-2010
Storage conditions : In the original container, at room temperature (range of 17-23 °C), away from direct sunlight.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Test system : New Zealand White Rabbit, SPF
- Rationale : Recognized by the international guidelines as the recommended test system.
- Source: Elevage Scientifique des Dombes
F-01400 Chatillon sur Chalaronne / France
- Number of animals per test : 3 (Animals of both sexes were used)
- Age at treatment : 11 weeks (male)
20 weeks (females)
- Acclimatization : Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
- Conditions : Standard Laboratory Conditions :
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70% and approximately 10-15 air changes per hour. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark.
- Accommodation : Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd,
Füllinsdorf) and haysticks 4646 (batch no. 0301, Provimi Kliba AG) were provided for gnawing.
- Diest : Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- water : Community tap water from Füllinsdorf, ad libitum.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: purified water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.
Number of animals:
3
Details on study design:
Four days before treatment, one flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.5 g of FAT 40'815/A was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 14 days (Coloration)
Other effects:
COLORATION: The test item caused blue staining of the treated skin of all animals. This effect was still
visible in one animal 14 days after treatment, at the end of the observation period.
No corrosive effects were noted on the treated skin of any animal at any of the
measuring intervals and no other clinical signs of test item related effects were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not induce significant or irreversible damage to the skin.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), FAT 40'815/A is considered to be "not irritating" to rabbit skin.
Executive summary:

The test item caused blue staining of the treated skin of all animals. This effect was still visible in one animal 14 days after treatment, the end of the observation period for all animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no other clinical signs of test item related effects were observed. Thus, the test item did not induce significant or irreversible damage to the skin. Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), FAT 40'815/A is considered to be "not irritating" to rabbit skin.