Registration Dossier
Registration Dossier
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EC number: 214-012-0 | CAS number: 1072-63-5
Skin irritation / corrosion
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:
- 2 005
- 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:
- 2 012
- Bibliographic source:
- Regulatory Toxicology and Pharmacology 64, 402-414
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-vinylimidazole
- EC Number:
- 214-012-0
- EC Name:
- 1-vinylimidazole
- Cas Number:
- 1072-63-5
- Molecular formula:
- C5H6N2
- IUPAC Name:
- 1-ethenyl-1H-imidazole
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
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