Registration Dossier
Registration Dossier
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EC number: 201-375-5 | CAS number: 81-77-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP/Guideline study with acceptable restrictions: - no data on purity of the test substance
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)
- Deviations:
- yes
- Remarks:
- (occlusive application of the test substance).
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6,15-dihydroanthrazine-5,9,14,18-tetrone
- EC Number:
- 201-375-5
- EC Name:
- 6,15-dihydroanthrazine-5,9,14,18-tetrone
- Cas Number:
- 81-77-6
- Molecular formula:
- C28H14N2O4
- IUPAC Name:
- 6,15-dihydroanthrazine-5,9,14,18-tetrone
- Details on test material:
- - Purity: Lab sample
- Storage: room temperature
- Physical state: solid, insoluble in water
- Stability: guaranteed by sponsor
- Safety precautions: gloves and face masks
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Further description: KFM-NZW
- Source: Kleintierfarm, Madoerin AG, CH-4414, Fuellindorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2000 - 2050 g (within ± 20% of mean value)
- Fasting period before study: no
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland (Routine analysis of the diet for nutritive contents and for contamination indicated no significant deviations expected to influence the study outcome);
- Water: ad libitum (Routine analysis for contamination indicated no significant deviations expected to influence the study outcome).
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after removing the gauze patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² (flanks).
- Type of wrap if used: gauze patch (20 cm²) carrying the test substance covered with aluminium foil (36 cm²) and held in place adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data.
SCORING SYSTEM: OECD scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Very slight erythema was seen (score 1) at the 1 and 24 hour-observation.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Very slight erythema was seen (score 1) at the 1 and 24 hour-observation.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal # 1, 2 and 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Very slight edema was seen (score 1) in 2 animals at the 1-hour observation. The effect was fully reversible by the 24 hour observation.
Any other information on results incl. tables
Table 1: Body weights at the start and after 3 days (end)
Animal no. |
1 |
2 |
3 |
At start |
2050 g |
2000 g |
2000 g |
After 3 days |
2150 g |
2010 g |
2020 g |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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