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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
Acute Dermal Irritation/Corrosion Study with Rabbits
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

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

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
Batch number: 022401

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Hygiene: Optimal hygienic conditions.
Room temperature: Average of 18.7 °C (continuous control and recording).
Relative humidity: Average of 52.8 % (contirnious control and recording).
Light: 12 hours light, 12 hours dark, only artificial light from 6 a.m. to 6 p.m.
Cages: Metal wire cages, Ehret GrnbH, D-79312, type KK 016R (79 cm x 59 cm bottom area, 38 cm height), single caging.

Feed: Altromin 2123 maintenanc1 diet for rabbits, rich in crude fiber, ad libitum. Analysis of the feed for ingredients and contaminants is performed randomly by Altromin, D-32791 Lage, Germany. Hay-briquettes (supplied bv SSNIFF, D-59494 Soest) are offered additionally as a dietary supplement.

Water: Tap water from an automatic watering system, ad libitum.
Environmental Enrichment: Aspen wood boards during acclimatisation and observation period. Exception: boards are withdrawn during the exposure.
Acclimatisation: 5 days.
Identification: Individual labelling with felt-tipped pen on an ear pinna and cage labels.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: The test substance was moistened with deionised water.
Controls:
yes
Amount / concentration applied:
500 mg

Samples with approximately 0.5 g of the test substance (thn weighed amounts of the individual doses of 500, 497 and 496 mg), were moistened with 1.0 ml deionised water and were placed on cellulose patches in a size of about 2.5 cm x 2.5 cm and were applied to the test sites. They were held in place by fixing them mal'ginally with non irritating tapes.
Duration of treatment / exposure:
4 h
Observation period:
The skins of the animals were examined for local alterations after the clipping procedure (one day before the application) and immediately before the application. The treated areas and the surrounding untreated skin (control area) of the animal . were examined for erythema/eschar and oedema as well as for other local alte,rations approximately 1, 24, 48 and 72 hours after patch removal. No further examinations were performed thereafter. The skin was examined using a cold light source KL 1500 electronic.
Number of animals:
3
Details on study design:
Scoring scheme for Acute Dermal lrritation/Corrosion.

Erythema / Eschar formation:
O No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).


Oedema formation:
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area well defined by definite raising).
3 Moderate oedema (raised approximately 1 mrn).
4 Severe oedema (raised more than 1 mm and 3xtending beyond area of exposure).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Other effects:
No systemic toxic signs were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the Directive 2001/59/EC, the test substance "STl571 F8" is not "irritating to skin".