Registration Dossier
Registration Dossier
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EC number: 209-935-0 | CAS number: 598-50-5
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:
- other: Guideline study.
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 12.05.1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Methylurea
- EC Number:
- 209-935-0
- EC Name:
- Methylurea
- Cas Number:
- 598-50-5
- Molecular formula:
- C2H6N2O
- IUPAC Name:
- methylurea
- Details on test material:
- - Name of test material (as cited in study report): Methylharnstoff, technisch (methylurea, technical grade)
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
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, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.17 and 3.25 kg for the males and 3.23 kg for the female
- Fasting period before study: 16 hours before administration no feed was given; water was available ad libitum.
- Housing: 1 animal per cage, stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm.
- Diet (e.g. ad libitum): KLIBA 341, 4 mm, FA. KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, about 130 g per animal per day
- Water: TAP WATER, about 250 ml per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping at least 15 hours before the beginning of the study
- 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 of the suspension
- Concentration: 80 % aequeous formulation (w/w), because of the natural moisture of the skin, distilled water was used to prepare the suspension so that the test was carried out under as physiological conditions as possible.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application volume: the test patch was covered with an about 0.5 mm layer of the 80 % suspension
- Application site: upper third of the back or flanks
- Type of wrap if used: porous dressing (4 layers of absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test substance was removed with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- according to 83/467/EEC criteria (29 july 1986)
READINGS
- 30 - 60 minutes after removal of the test patches and 24h, 48h and 72 h after the beginning of application.
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:
- The test substance was not irritating under the conditions of this test. Mean score was 0.0 for both erythema and edema.
Very slight erythema was observed in a single rabbit at the 4-hour reading. No edema was observed in any animal at this time point. No signs of irritation were noted in any animal at the readings at 24, 48 and 72 hours. - Other effects:
- No other effects
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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