Registration Dossier
Registration Dossier
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EC number: 278-248-6 | CAS number: 75535-16-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan - March1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
- EC Number:
- 228-799-3
- EC Name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
- Cas Number:
- 6359-45-1
- Molecular formula:
- C23H29N2.Cl
- IUPAC Name:
- 2-{2-[4-(diethylamino)phenyl]vinyl}-1,3,3-trimethyl-3H-indolium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Violet 16
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: mean 2.59 kg (all male)
- Housing: single in stainless steel cages
- Diet (e.g. ad libitum): Kliba 341, 4 mm - ca. 130 g/animal/day; Klingentalmühle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water - ca. 250 mL/animal/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with aqua dest to provide good skin contact
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: test patches were secured in position with a porous dressing (four lavers of absorbent gauze + porous bandage).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
30-60 min after removal of patches; and 24 h, 48 h, 72 h afer start of application
SCORING SYSTEM:
- Method of calculation: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corrosive effects were noted on treated skin at any time.
At 24 h, no erythema score could be derived since the test item caused staining of the application site.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause any signs of irritation/corrosion on rabbit skin. The substance is not classifiable according to the CLP Regulation.
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