Registration Dossier
Registration Dossier
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EC number: 281-589-3 | CAS number: 83969-12-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 - 22 Nov 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- yes
Test material
- Reference substance name:
- 5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
- EC Number:
- 281-589-3
- EC Name:
- 5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
- Cas Number:
- 83969-12-4
- Molecular formula:
- C17H27N6S.CH3O4S
- IUPAC Name:
- 4-{2-[(2E)-5-[bis(propan-2-yl)amino]-3-methyl-2,3-dihydro-1,3,4-thiadiazol-2-ylidene]hydrazin-1-ylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium methyl sulfate
- Test material form:
- liquid
- Details on test material:
- Basic Blue 159 methyl sulfate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: one animal/cage (type III)
- Diet (e.g. ad libitum): "ssniff K4", ad libitum
- Water (e.g. ad libitum): mains water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl - Duration of treatment / exposure:
- 4h exposure
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed patch (hypoallergenic)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4h after exposure
OBSERVATION TIME POINTS
1h, 24h, 48h, 72h, 7d and 14d
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
irritation scores
| animal nr | observation time | |||
| 24h | 48h | 72h | ||
| I | erythema | 0 | 0 | 0 |
| edema | 0 | 0 | 0 | |
| II | erythema | 0 | 0 | 0 |
| edema | 0 | 0 | 0 | |
| III | erythema | 0 | 0 | 0 |
| edema | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not cause any signs of irritation on rabbit skin. The substance is not classifiable according to CLP criteria.
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