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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:
09 MAR 2000 - 19 JUN 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW)BR
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 25 weeks
- Weight at study initiation: mean 4.14 kg (range from 3.32 to 4.86 kg)
- Housing: All rabbits were housed in an air-conditioned room of about 28 m² in the Institute of Toxicology. They were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm) with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least three times a week. The cages were cleaned before the start of the study.
- Diet (e.g. ad libitum): ad libitum, the diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the German government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
- Water (e.g. ad libitum): ad libitum, the drinking water is periodically analyzed according to the German regulations for human drinking water.
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 46 - 65
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): in some drops of Aqua pro injectione

VEHICLE
- Amount(s) applied (volume or weight with unit): some drops of Aqua pro injectione
- Lot/batch no. (if required): 0189
Duration of treatment / exposure:
4 h
Observation period:
The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to day 8 of the study.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: patch, the patches were fastened to the left side of the animals backs and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any test material residues were wiped off
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to day 8 of the study

SCORING SYSTEM:
- Method of calculation: Skin changes at the application sites were evaluated according to the DRAIZE-, OECD- and EEC recommendations.

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
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed in the treated areas.
Other effects:
Symptoms
No signs of clinical toxicity were detected.

Mortality
All animals survived the observation period.

Body weight
Body weight development of the treated rabbits was inconspicuous.

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The test substance was shown to cause no skin irritation when applied under semiocclusive conditions.
Executive summary:

The skin irritation potential of the registered substance was tested in rabbits according to OECD Guideline 404 and GLP. The test item was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for further 7 days. The test substance was shown to cause no skin irritation.