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

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005
Reference Type:
publication
Title:
Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies
Author:
Kolle SN, Sullivan KM, Mehling A, van Ravenzwaay B and Landsiedel R
Year:
2012
Bibliographic source:
Regulatory Toxicology and Pharmacology 64, 402-414

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1-Vinylimidazol
- Test substance no.: 00/0335-2
- Physical state: liquid
- Analytical purity: 99.8 %
- Lot/batch No.: 19812968E0
- Stability under test conditions: the stability under storage conditions over the study period was guaranteed by the sponsor
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A. (01540 Vonnas, France)
- Age at study initiation: 7-8 months
- Weight at study initiation: 3.91-4.35 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor area : 3000 cm2
- Diet: Kliba-Labordiät, Kaninchen & Meerschweinchenhaltung "GLP" (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland), ca. 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
14 days but study was discontinued after 7 days because all animals were free of findings
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 x 2.5 cm
- Type of wrap: semiocclusive (test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water 1:1
- Time after start of exposure: after 4 hours of exposure

SCORING SYSTEM: as described in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no edema observed
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no edema observed
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no edema observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met