Registration Dossier
Registration Dossier
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EC number: 202-414-9 | CAS number: 95-38-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Feb 1989 to 15 Feb 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol
- EC Number:
- 202-414-9
- EC Name:
- 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol
- Cas Number:
- 95-38-5
- Molecular formula:
- C18H34N2O - C24H46N2O
- IUPAC Name:
- 2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol
- Reference substance name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- EC Number:
- 244-501-4
- EC Name:
- (Z)-2-(8-heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol
- Cas Number:
- 21652-27-7
- Molecular formula:
- C22H42N2O
- IUPAC Name:
- 2-(2-heptadec-8-en-1-yl-4,5-dihydro-1H-imidazol-1-yl)ethanol
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TK 10648
- Substance type: organic
- Physical state: liquid; insoluble in water
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Analytical purity: lab sample
- Lot/batch No.: EN 42441
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2100-2380 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20+/-3 °C
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The animals were killed for animal protective reasons 24 hours after removing the bandage.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- Coverage: 12 - 16 cm2
- Type of wrap: The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape.
SCORING SYSTEM: OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The test article induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage.
- Other effects:
- Moderate to severe losses of weight were detected in all animals at termination of the study 24 hours after removing the bandages.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- Based on the study results the substance is considered corrosive to skin.
- Executive summary:
The test article induced maximum irritant effects which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 24 hours after removing the bandage. It has to be concluded that the test article has corrosive effects in albino rabbits. Moderate to severe losses of weight were detected in all animals at termination of the study 24 hours after removing the bandages.
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