Registration Dossier
Registration Dossier
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EC number: 289-214-5 | CAS number: 86261-90-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-04-08 to 1986-04-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
- EC Number:
- 289-214-5
- EC Name:
- 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
- Cas Number:
- 86261-90-7
- Molecular formula:
- C9H14N2O3
- IUPAC Name:
- 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 2.76 kg; females 2.86 kg
- Housing: single in stainless steel cages
- Diet: Kliba 341, 4mm, Fa. Klingentalmuehle AG, Kaiseraugst, CH, ca. 130 g/d
- Water: tap water, ca. 250 mL/d
- Acclimation period: at least 8 d
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:
- other: clipping
- Vehicle:
- water
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80% (w/w) - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5*2.5 cm; upper third of the back or flanks
- Type of wrap if used: four layers of absorbent gauze plus porous bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)
SCORING SYSTEM: OECD Draize scoring system
30 -60 min after patch removal the first reading was performed; the relevant readings for classification were performed after 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- No irritant effects seen in any reading.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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