Registration Dossier
Registration Dossier
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EC number: 201-182-6 | CAS number: 79-16-3
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
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-methylacetamide
- EC Number:
- 201-182-6
- EC Name:
- N-methylacetamide
- Cas Number:
- 79-16-3
- Molecular formula:
- C3H7NO
- IUPAC Name:
- N-methylacetamide
- Details on test material:
- - Name of test material (as cited in study report): N-METHYLACETAMIDE, 98/392-1
- Physical state: Colorless solid
- Analytical purity: 99.82% (GC)
- Lot/batch No.: Tank 143
- Date of manufacturing: September 24, 1998
- Stability: Reanalysis: stable until January 1999.
- Storage condition of test material: at room temperature (approx. 20°C) away from direct
sunlight.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-0 1400 Chatillon sur Chalaronne
- Number of animals: 1 male, 2 females
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 2.589 kg, females: 2.702 and 2.853 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with haysticks and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3410 rabbit maintenance diet ad libitum (batch no. 62/98). Provimi Kliba AG, 4303 Kaiseraugst, Switzerland.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum, provided by water bowls.
- Acclimatization period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour,
- Photoperiod (hrs dark / hrs light): 12 hour Iight/dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Ihe test article is a solid at room temperature. To liquify the test article, it was warmed in a waterbath to approximately 40°C, and allowed to cool slightly for application.
- Amount(s) applied (volume or weight with unit): 0.5 ml to each rabbit.
- Concentration (if solution): undiluted.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: the test article was applied to approximately 6 cm2 of the intact skin of the clipped area. lt was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. Ihe dressing was wrapped around the abdomen and anchored with tape.
- Type of wrap if used: 3 days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: 4 h
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
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
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
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