Registration Dossier
Registration Dossier
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EC number: 248-957-5 | CAS number: 28313-51-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-11-15 to 1982-11-23
- 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:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- version 1982
- GLP compliance:
- no
Test material
- Reference substance name:
- [2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate
- EC Number:
- 248-957-5
- EC Name:
- [2-[ethyl[3-methyl-4-[(3-phenyl-1,2,4-thiadiazol-5-yl)azo]phenyl]amino]ethyl]trimethylammonium methyl sulphate
- Cas Number:
- 28313-51-1
- Molecular formula:
- C22H29N6S.CH3O4S
- IUPAC Name:
- {2-[ethyl({3-methyl-4-[(E)-2-(3-phenyl-1,2,4-thiadiazol-5-yl)diazen-1-yl]phenyl})amino]ethyl}trimethylazanium methyl sulfate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Red 23 Methyl sulfate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Weight at study initiation: average: 2.7kg
- Housing: individual cages
- Diet (e.g. ad libitum): "mümmel z" (ssnif) ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%rH
-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): 500mg of with water wetted test substance on a 2.5 x 2.5cm patch - Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72 h and 8days after removal of patch
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose and elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or olive oil
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
(Indicate if minutes, hours or days)
1, 24, 48 and 72 h and 8 days after removal of patch
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
- Remarks:
- evaluation of skin reddening was made difficult due to the coloured skin caused by the test substance
- 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
| animal nr | observation time | |||
| 24h | 48h | 72h | ||
| I | erythema | * | * | * |
| edema | 0 | 0 | 0 | |
| II | erythema | * | * | * |
| edema | 0 | 0 | 0 | |
| III | erythema | * | * | * |
| edema | 0 | 0 | 0 | |
* = coloured skin caused by the test substance
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test substance is determined as not irritating to rabbit skin.
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