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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): "WS 400304"
- Molecular formula: C7H8O3S.C5H5N
- Substance type: organic
- Physical state: White solid
- Analysis: acid value 202, amine value 2
- Trade name: BYK-LP K 20953
- Supplier: BYK Chemie
- Lot/batch No.: CD-05-167
- Expiration date of the lot/batch: 2008-01-01
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Other:
* pH=3.74
* density 1.25 g/cm3 at 60 °C
* Soluble in water

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Number and sex: 3 males
- Bodyweights (at the start and at the termination of the study):
Animal No. 61: 2.1 kg and 2.2 kg
Animal No. 62: 2.2 kg and 2.4 kg
Animal No. 63: 2.1 kg and 2.3 kg
- Cages: individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
- Room temperature: 19.0 °C
- Relative humidity: average of 48.8 %
- Light: artificial light from 6 a.m. to 6 p.m.
- Feed: altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Hay-briquettes (supplied by SSNIGG, D-59494 Soes) were offered additionally as a dietary supplement
- Water: tap water from an automatic watering system, ad libitum
- Acclimatisation: 5 days (animal No. 61) and 12 days (animal No. 62 and 63)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: The surrounding of the administration area served as a negative control
Amount / concentration applied:
0.5 g test substance (the weighed amount of the individual dose was 505 mg) was moistened with 1.0 mL deionised water and were placed on gauze patches in a size of about 2.5 cm x 2.5 cm.
Duration of treatment / exposure:
4 hours
Observation period:
The skins were examined for local alterations one day before the administration of the test substance and immediately before the administration. The treated areas of the animals were examined approximately 1, 24, 48 and 72 hours after patch removal.
Number of animals:
3
Details on study design:
An electric hair clipper, Aesculap GH 204 with a 1 mm cutterhead, was used for clipping of the hair.
Patches were held in place by fixing them marginally with non irritating tapes. The application sites were covered semi-occlusively by a dressing. Access by the animals to the application sites was prevented by a plastic collar.
At the end of the exposure period the dressings, the tapes with the patches and the collars were removed.
The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia).
The surrounding of the administration area, i.e. the untreated skin, served as a negative control.
The skin was examined using a cold light source KL 1500 electronic.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
Other effects:
no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating